2009

Gore Launches 31-mm Excluder AAA Endoprosthesis
April 28, 2009—W. L. Gore & Associates (Flagstaff, AZ) announced the availability of a 31-mm-diameter version of the Gore Excluder abdominal aortic aneurysm (AAA) endoprosthesis for the treatment of AAAs in patients with aortic inner neck diameters up to 29 mm. Other enhancements include a flattop design that enables greater production efficiency, an additional pair of proximal anchors to help ensure excellent fixation, and a lengthening of the trunk from 7 to 8 cm to accommodate larger anatomies. The US Food and Drug Administration approved the 31-mm-diameter version in March 2009. It has been available outside the US since 2004 and has been implanted in more than 3,300 patients. The 31-mm Gore Excluder is available in 13-, 15-, and 17-cm lengths. The company has also added a 32-mm X 4.5-cm aortic extender component to its product line. Both the new trunk-ipsilateral leg and aortic extender components are 20-F introducer sheath compatible, the company stated.

"The availability of the larger aortic diameter Gore Excluder devices will certainly broaden the range of American patients that can have their aneurysms treated with endovascular repair," commented Jon Matsumura, MD. "This less invasive option has the clear benefits of a more rapid recovery and lower postoperative risk of fatal complications compared to open surgical repair."

Medtronic Initiates ENGAGE Global AAA Study
April 8, 2009—Medtronic, Inc. (Minneapolis, MN) announced the commencement of the ENGAGE (Endurant Stent Graft Natural Selection Global Postmarket Registry) study, which will evaluate the performance of the company's Endurant stent graft for the endovascular repair of abdominal aortic aneurysms (AAAs). ENGAGE is expected to enroll 1,200 patients with AAAs at up to 80 medical centers worldwide. Patients who meet the single-arm study's inclusion criteria will be treated with the Endurant system and followed for 5 years. The study's primary endpoint is treatment success at 12 months. Treatment success is a composite endpoint of criteria including successful technical delivery and deployment of the stent graft, as well as freedom from aneurysm swelling, endoleaks, aneurysm rupture, conversion to surgery, graft migration, and graft occlusion. The Endurant stent graft system received CE Mark approval in July 2008. In the United States, it is limited to use in an investigational clinical trial.

The seven-member ENGAGE executive committee is composed of Robert Fitridge, MD, from Australia; Dittmar B?ckler, MD, from Germany; Paul Hayes, MD, from England; Furuzan Numan, MD, from Turkey; Juan Carlos Parodi, MD, from Argentina; Vicente Riambau, MD, from Spain; and Yehuda Wolf, MD, from Israel. Dr. Fitridge enrolled the first patient in the study on March 24.

"ENGAGE seeks to involve more patients at more sites and in more countries than any previous study of its kind," commented Dr. Fitridge. "The data this multicenter international study collects on the Endurant stent graft will help physicians worldwide determine how to best treat AAAs in the real-world setting of standard clinical practice."

Finnish Study Reports Midterm Data on Cook Medical's Zenith AAA Device
April 1, 2009—Terhi Nevala, MD, et al have published an assessment of midterm findings from the Finnish multicenter study of Cook Medical's (Bloomington, IN) Zenith stent graft in the treatment of abdominal aortic aneurysms (AAAs) in the April issue of the Journal of Vascular and Interventional Radiology (2009;20:448–454). Between January 2001 and December 2005, a Zenith stent graft was used for endovascular repair of an infrarenal AAA in 206 patients. The mean patient age was 73.2 ± 7.3 years. Bifurcated grafts were used in 196 patients (96.1%), aortouni-iliac grafts were used in seven patients (3.4%), and a tubular graft was used in one patient (0.5%). The mean follow-up period was 2.4 ± 1.7 years.

The investigators reported that the 30-day mortality rate was 2.9%. The overall survival rates at 1-, 3-, and 5-year follow-up were 93.3%, 78.7%, and 64.5%, respectively. None of the patients died from AAA rupture. The primary and assisted technical success rates 1 week after endovascular aneurysm repair were 82% and 90.3%. The primary clinical success rates at 1-, 3-, and 5-year follow-up were 90.6%, 85.6%, and 83.5%. Twenty-seven patients (13.1%) underwent a secondary intervention during the study period.

The investigators concluded that an 83% rate of freedom from repeat vascular intervention over a period of 5 years, as well as an absence of structural failures or aneurysm ruptures, demonstrates that the Zenith stent graft is associated with favorable midterm results.

Five-Year Study Supports Wider Use of EVAR for Ruptured AAAs
March 31, 2009—The Society for Vascular Surgery (SVS) announced the publication of a study in the April issue of the Journal of Vascular Surgery by James McPhee, MD, et al that examines the national frequency, predictors, outcomes, and effects of institutional volume metrics in cases when endovascular aortic repair (EVAR) was used to repair ruptured abdominal aortic aneurysms (RAAAs) between 2001 and 2006 (2009;49:817–826). The SVS noted that with the wider acceptance and success of EVAR over the years for the elective treatment of nonruptured AAAs, there has been an increased interest in similar treatment of RAAAs. Most patients who experience RAAAs do not survive long enough to obtain medical care, and the mortality rate for patients who do survive and undergo open surgical repair exceeds 40%.

In this study, data were secured through the Nationwide Inpatient Sample to evaluate operative outcomes. The study included an estimated 27,750 hospital discharges for RAAAs, 11.5% of which were treated with EVAR. Procedure volume was determined for each institution, and hospitals were categorized as low, medium, or high volume. The investigators noted that even after adjustment for hospital surgical volume characteristics, teaching hospitals continued to show lower mortality risks following RAAA repair than nonteaching hospitals.

The investigators found that EVAR utilization increased over time (5.9% in 2001 to 18.9% in 2006; P < .0001), while overall RAAA rates remained constant. EVAR had a lower overall inhospital mortality than open repair (31.7% vs 40.7%; P < .0001), an effect that amplified when stratified by institutional volume. On multivariable regression, open repair independently predicted mortality (odds ratio [OR], 1.56; 95% confidence interval [CI], 1.29–1.89). EVAR usage for RAAAs increased with age (> 80 years) (OR, 1.58; 95% CI, 1.30–1.93), high elective EVAR volume (> 40 years) versus medium (19–40 years) (OR, 2.65; 95% CI, 1.86–3.78) and low (<19 years) (OR, 5.37; 95% CI, 3.60–8). EVAR had a shorter length of stay (11.1 vs 13.8 days; P < .0001), higher discharges to home (65.1% vs 53.9%; P < .0001), and lower charges ($108,672 vs $114,784; P < .0001).

The investigators stated that these data showed that EVAR had a lower postoperative mortality rate than open repair of RAAAs in the United States. Higher elective open repair as well as RAAA volume increased this mortality advantage for EVAR. These results support regionalization of RAAA repair to high-volume centers whenever possible and a wider adoption of endovascular repair nationwide, concluded the investigators.

IMPROVE Study Will Compare EVAR and Surgery for Ruptured AAAs
April 9, 2009—At the 31st CX International Symposium in London, UK, Janet Powell, MD, of Imperial College London presented a summary of the upcoming IMPROVE (Immediate Management of the Patient with Rupture: Open Versus Endovascular Repair) study. Imperial College London is a cosponsor of IMPROVE.

Dr. Powell has outlined the IMPROVE trial on the Imperial College Faculty of Medicine's Web site as follows. The multicenter, randomized, controlled trial's aim is to compare the mortality from ruptured abdominal aortic aneurysms (RAAAs) in patients treated by an endovascular-first strategy versus the conventional treatment of immediate open repair. The trial will be conducted at specialist vascular centers credentialed for emergency endovascular AAA repair in Europe.

Initial management of patients with suspected RAAAs will be conducted with a fluid restriction protocol. When the inhospital clinical diagnosis of RAAA has been established, patients will be randomized to either an endovascular-first strategy or to immediate open surgical repair. Patients randomized to an endovascular-first strategy will be sent for an immediate computed tomography (CT) scan to determine their anatomical suitability for endovascular repair (approximately 60% of patients will be suitable). Suitable patients will then undergo immediate endovascular repair, and the remainder will undergo open repair.

The primary outcome is 30-day mortality. Secondary outcome measures include 24-hour, inhospital, and 1-year mortality, complications, and morbidities associated with the two treatment strategies, as well as quality of life and cost-effectiveness. The trial plans to recruit 600 patients over a 27-month period to provide 90% power to detect an improvement in 30-day mortality of 14% from 44.6% in the open repair group to 30.4% in the endovascular-first strategy group.

Eligibility for the trial will include all nonmoribund patients with a clinical diagnosis of RAAA made inhospital, including patients transferred from other hospitals with a diagnostic CT scan. The trial will exclude patients with known connective tissue disorders (eg, Marfan syndrome) in whom endovascular repair may not be beneficial, patients with known previous repair of an RAAA, because either open or endovascular procedures are likely to be very complex, and there are no guidelines for anatomical restriction to repair, and deeply unconscious or moribund patients with minimal chance of recovery.

Each center has a free choice of endografts and technical approach to the aorta, and CT is optional for the open repair group. After aneurysm repair, each patient's general practitioner is notified. Patients who have been discharged following an operation will be required to attend outpatient care according to local clinical protocols. At 3 and 12 months after the operation, the patient will be asked to attend an outpatient appointment to obtain the following information: EuroQol form completed (3 and 12 months), CT scan for patients with endovascular repair (3 months only), Health Resources questionnaire for the patient to complete at home (3 and 12 months) for UK patients, and incidences of reinterventions and major morbidities (eg, myocardial infarction, stroke, renal replacement therapy, amputation) will be recorded.

TEVAR Shown to Improve 30-Day Event Rates
March 30, 2009—A study presented by Davy Cheng, MD, during the Innovation in Intervention: i2 Summit 2009 at the American College of Cardiology's 58th annual scientific session in Orlando, Florida, demonstrated that thoracic endovascular aortic repair (TEVAR) reduces early death and ischemic events including stroke, paraplegia, renal insufficiency, and myocardial infarction compared with open surgery; however, long-term mortality is similar with the two techniques.

According to the American College of Cardiology, the analysis of 41 comparative studies with 4,918 patients showed a decidedly early mortality benefit for TEVAR. All data from controlled trials of TEVAR versus open repair of thoracic aortic pathologies were obtained from medical databases and conference abstracts and combined through meta-analyses. Metaregression was then performed to evaluate the impact of baseline risk factor imbalances, study design, and thoracic pathology.

The investigators found that there was an overall 76% reduction in early all-cause mortality (30 days); however, after 1, 2, and 3 years, there was no proven mortality difference between the two procedures. With TEVAR, paraplegia was reduced by 56%, and stroke was reduced by 54% compared to open surgery. Myocardial infarction, arrhythmia, renal insufficiency, and allogeneic blood transfusion rates were also significantly reduced after TEVAR compared with open surgery.

Dr. Cheng stated that the investigators worked with the European Association for Cardiothoracic Surgery Working Group led by Marko Turina, MD. Their purpose was to evaluate all comparative studies published from the early 1990s to October 2008 to get a full picture of the merits and disadvantages of the two techniques. However, many of those studies are retrospective reviews or observational studies, and most have not compared TEVAR with open surgery, which is the standard of care, Dr. Cheng noted.

"We are very encouraged looking at these data," commented Dr. Cheng. "This is probably the most comprehensive analysis in the literature as of today looking at TEVAR versus open surgical repair of the thoracic aorta. There appears to be increasing data demonstrating that TEVAR is indeed beneficial for patients. Nonetheless, we do need to emphasize that the sustained benefit of survival more than 1 year has not yet been proven."

Legislation Seeks to Expand SAAAVE Medicare Screening
March 4, 2009—The Society for Vascular Surgery (SVS) announced that legislation (HR 1213) has been introduced to make the Screening Abdominal Aortic Aneurysms Very Efficiently (SAAAVE) Act available to more Medicare beneficiaries. Representatives Gene Green (D-TX) and John Shimkus (R-IL), who serve on the House Energy and Commerce Health Subcommittee, introduced HR 1213 on February 26, 2009. The bill unlinks abdominal aortic aneurysm (AAA) screening from the Welcome to Medicare Physical Examination and expands the one-time screening to 65- to 75-year-old Medicare beneficiaries who are at risk for AAA. These include men who have ever been smokers and men and women with a family history of AAA.

"Initial passage of the SAAAVE Act in 2005 demonstrated Congress's desire to prevent unnecessary American deaths from ruptured AAAs," commented Robert Zwolak, MD, chair of the SVS Health Policy Committee and SVS Vice President. "However, linking AAA screening to the Welcome to Medicare Physical Examination is too complex, limiting access to these life-saving screenings. In order to implement the original congressional intent, this preventive measure must be unlinked from the physical exam, thus allowing all appropriately targeted Medicare beneficiaries to undergo screening as recommended by the United States Preventive Services Task Force."

NeuroVasx's cPax Receives CE Mark Approval
March 25, 2009—NeuroVasx, Inc. (Maple Grove, MN) announced that its cPax aneurysm treatment system has received CE Mark approval for the minimally invasive embolization of cerebral aneurysms. NeuroVasx's application for 510(k) marketing clearance of the cPax in the United States is pending.

According to NeuroVasx, the cPax device is a polymer strand delivered through a microcatheter using the same delivery technique as the currently used platinum coil technology. The cPax was designed to achieve more complete filling of the aneurysm using fewer devices and to provide the physician the ability to detach the device at any point versus a fixed detachment zone common to platinum coils. The polymeric material also allows for noninvasive computed tomography and magnetic resonance imaging scans free of metallic artifacts for a more accurate patient follow-up assessment. Its soft, pliable material allows for packing densities of up to 60%, which is advantageous for treating larger or wide-necked aneurysms, the company noted.

FDA Approves Endologix's IntuiTrak Express
March 10, 2009—Endologix, Inc. (Irvine, CA) announced that it has received Food and Drug Administration (FDA) approval of the IntuiTrak Express delivery system, which is designed for the delivery of the Powerlink XL stent graft through the IntuiTrak 19-F introducer sheath during the endovascular repair of abdominal aortic aneurysms (AAA) in patients with aortic necks ≤ 32 mm in diameter. Endologix will conduct a limited market release with the IntuiTrak Express over the next several months and expects a full commercial launch in the United States in the third quarter of 2009.

According to the company, the family of IntuiTrak delivery systems was first approved by the FDA on October 22, 2008. The IntuiTrak product line is a selection of flexible low-profile delivery systems with hemostasis control and hydrophilic coating to facilitate smooth delivery, particularly in patients with limited or difficult vascular access. The integrated introducer sheath eliminates the need for sheath exchanges in introducing ancillary devices during the endovascular abdominal aortic aneurysm procedure, which potentially reduces procedure time, blood loss, and vessel trauma, the company stated.

W. L. Gore's 31-mm Excluder AAA Device Cleared
March 24, 2009—W. L. Gore & Associates (Flagstaff, AZ) announced that it has received approval from the United States Food and Drug Administration to market a 31-mm diameter version of the Gore Excluder abdominal aortic aneurysm endoprosthesis for treatment in patients with aortic inner neck diameters up to 29 mm. Other enhancements include a flat-top design for greater production efficiency, an additional pair of proximal anchors to help ensure fixation, and a lengthening of the trunk from 7 cm to 8 cm to accommodate larger anatomies. The 31-mm device will be available for clinical use in the United States in May 2009, and it has been available outside of the United States since 2004. The 31-mm Gore Excluder abdominal aortic aneurysm endoprosthesis will be available in 13-, 15-, and 17-cm lengths. A new 32-mm X 4.5-cm aortic extender component will also be available. The new trunk-ipsilateral leg and aortic extender components are 20-F introducer-sheath compatible, the company stated.

Aptus Endosystems' STAPLE-2 Completes Enrollment
February 10, 2009—Aptus Endosystems, Inc. (Sunnyvale, CA) announced it has completed primary enrollment in STAPLE-2, the US pivotal clinical study to demonstrate the safety and effectiveness of the Aptus endovascular abdominal aortic aneurysm (AAA) repair system. The device is an endograft that incorporates the company's endovascular stapling system.

The investigators enrolled 155 sequential patients across 25 US clinical trial sites as part of the study to assess the perioperative and long-term performance of the company's combination of stent graft and endovascular stapling system in the treatment of AAA. Patients enrolled in the study are subject to 1-, 6-, and 12-month follow-up reviews. The company will then submit data to the Food and Drug Administration (FDA) for review under the premarket approval process. The company intends to submit its final data module to the FDA early next year. Ronald Fairman, MD, and Manish Mehta, MD, are national coprincipal investigators for the STAPLE-2 study.

The company stated that STAPLE-1, the phase 1 study that enrolled 21 patients at five US institutions, produced positive clinical outcomes, which were presented in November 2008 at the VEITH Symposium in New York City. These study results showed no device-related endoleaks (type I, III, or IV) and no device migration as late as 2 years postprocedure for those patients who had reached that follow-up. Additionally, more than 90% of patients demonstrated a clinically significant reduction in their aneurysm size as early as 6 months postprocedure.

"The 1-year follow-up outcome data is particularly robust and impressive," commented Dr. Fairman. "The completion of the pivotal STAPLE-2 study brings the therapy to a new level. This truly novel concept of active proximal fixation using helical ïscrews' combined with a modular endograft on a very small, flexible delivery system expands the option for endovascular therapy to a greater pool of patients."

"This endovascular stapling technology facilitates our ability to perform aneurysm repair in a manner that closely approximates the suturing technique that is the foundation of open surgical repair," added Dr. Mehta. "Having the ability to separately control the fixation of the endograft in a catheter-based technology is a new and clinically important capability relative to improved outcomes for patients."

Endologix to Fully Launch IntuiTrak AAA Delivery System
February 10, 2009—Endologix, Inc. (Irvine, CA) announced that it expects to conduct a full market launch in the second quarter of 2009 of the company's new IntuiTrak delivery system, which received Food and Drug Administration approval in October 2008 and is currently in limited market release. The device was featured in a live case performed by Zvonimir Krajcer, MD, Edward Diethrich, MD, and Venkatesh G. Ramaiah, MD, at the International Congress XXII on Endovascular Interventions in Scottsdale, Arizona. Dr. Diethrich is chairman of the annual congress. The IntuiTrak system is designed for the delivery and deployment of Endologix' Powerlink stent graft for the endovascular repair of abdominal aortic aneurysm.

"Due to its low profile and integrated sheath, IntuiTrak is ideal for the percutaneous treatment of patients with abdominal aortic aneurysms," commented Dr. Krajcer.

FDA Approves Modification to Gore TAG
February 8, 2009—Gore & Associates (Flagstaff, AZ) announced that it has received Food and Drug Administration (FDA) approval to market a modified version of the Gore TAG thoracic endoprosthesis for the treatment of thoracic aortic aneurysms (TAAs). The company made the announcement at the International Congress XXII of Endovascular Interventions XXII in Scottsdale, Arizona. US distribution of the device with an upgraded delivery system has begun and will be completed during the next few months. The Gore TAG thoracic endoprosthesis was first approved by the FDA in March 2005 and has received regulatory approval in Europe, Japan, and South Korea.

According to the company, the improved delivery catheter now includes a soft, flexible tip to the leading end of the delivery system. The soft tip improves flexibility at the wire/catheter interface to facilitate tracking through challenging aortic anatomy. The hub component has also been modified to improve ease of use and durability. The device internally relines the thoracic aorta and isolates the diseased segment from blood circulation. It is composed of an ePTFE graft with an outer self-expanding nitinol support structure to provide device flexibility and material durability, the company stated.

Medtronic Commences VITALITY Postmarket Study
January 26, 2009—Medtronic, Inc. (Minneapolis, MN) announced the first enrollment in VITALITY (Endovascular Repair Using the Talent Abdominal Stent Graft in Abdominal Aortic Aneurysms), the company's postmarket clinical study of its Talent abdominal stent graft for the endovascular repair of abdominal aortic aneurysms. VITALITY will be composed of 260 patients at up to 30 different US sites. The study's primary endpoint is freedom from aneurysm-related mortality at 5 years. Aneurysm-related mortality is defined as death from aneurysm rupture or from any procedure intended to prevent it. The study design incorporates a test group of 166 patients from an earlier study that supported the device's FDA approval in 2008, as well as an additional 94 new subjects to be prospectively enrolled. All subjects will be followed for 5 years. Luis Sanchez, MD, is VITALITY's principal investigator. George Pliagas, MD, performed the first study implant on December 29, 2008, at St. Mary's Medical Center in Knoxville, Tennessee.

Study Results Published for LeMaitre's EndoFit Thoracic Stent Graft
January 6, 2009—LeMaitre Vascular, Inc. (Burlington, MA) announced the publication of a 2-year study by Lefeng Qu, MD, and Dieter Raithel, MD, in the Journal of Endovascular Therapy confirming the use of LeMaitre's endovascular thoracic stent graft in the treatment of thoracic aortic aneurysms and dissections (2008;15:530–538).

According to the company, LeMaitre Vascular's EndoFit thoracic stent graft demonstrated 100% technical success in the study, which was a retrospective review of 87 patients undergoing endovascular repair of the thoracic aorta at Nuremberg Southern Hospital in Germany. There were no device- or aneurysm-related deaths, and there was a low incidence of device- or aneurysm-related complications. The company noted that the availability of multiple custom sizes in the study allowed treatment of the majority of thoracic lesions. Thirty-five percent of patients in the study were treated with custom-manufactured stent grafts. The investigators further praised the device's cartridge-loading technique, which can reduce the number of delivery catheter insertions in cases requiring multiple stent grafts.

Data from the study were compiled from 87 patients treated with the EndoFit stent graft for thoracic aneurysm or thoracic dissection between December 2005 and December 2007. The majority of patients were deemed unfit for open surgery due to high-risk comorbidities. Twenty percent of cases were performed emergently. The investigators deployed the EndoFit thoracic stent graft successfully in all cases. The mean procedure duration was 40 minutes. The investigators conducted patient follow-up with CT imaging at discharge, at 1, 3, and 6 months, and then annually for the remainder of the study. Patient follow-up averaged 15.2 months. There were no device-related deaths. There was no stent graft kinking, collapse, or dislocation, and no postprocedure rupture or conversion to open surgery.

2008

Cook Medical's Zenith Low-Profile AAA Trial Approved
November 20, 2008—At the VEITH Symposium in New York City, Cook Medical (Bloomington, IN) announced that it has received conditional approval from the FDA to begin a clinical trial for its Zenith Low-Profile abdominal aortic aneurysm (AAA) endovascular graft under an investigational device exemption. The trial will be conducted at 24 sites. It is designed to evaluate the safety and effectiveness of the smaller endograft delivery system in 120 patients, enabling the endovascular treatment of AAA patients with smaller vascular access vessels who otherwise may not have been candidates for minimally invasive endovascular treatment. Cook states that the Zenith Low-Profile system uses a 16-F delivery sheath, significantly narrower in diameter than the company's current system, which is 20- to 24-F. This advanced delivery system enables physicians to reduce the need for a surgical cutdown to access the femoral artery for device insertion, thereby allowing the use of the less-invasive percutaneous entry technique in many cases, the company stated.

In other company news, on October 27, 2008, Cook Medical announced that it has received CE Mark approval for the MiraFlex High Flow microcatheter, which is indicated for use in small-vessel or superselective anatomy for diagnostic and interventional procedures. The MiraFlex High Flow will be marketed in Europe for use in neurological, peripheral, and coronary vasculature practices.

Free Medicare AAA Screening Benefit Extended to 1 Year
December 19, 2008—The Society for Vascular Surgery announced that the Centers for Medicare & Medicaid Services has extended the one-time, free abdominal aortic aneurysm screening for at-risk Medicare beneficiaries. The benefit will be available for 12 months after enrollment beginning January 1, 2009. The benefit became law on February 8, 2006 and was originally offered for a 6-month period after enrollment beginning January 1, 2007. Men who have smoked sometime during their life and men and women with a family history of abdominal aortic aneurysm qualify for the free screening benefit as part of their "Welcome to Medicare" physical exam.

Medtronic's Talent AAA Stent Graft Launched on Xcelerant Hydro Delivery System
November 19, 2008—Medtronic (Minneapolis, MN) announced the US launch of the Talent abdominal stent graft on the Xcelerant Hydro delivery system. The Xcelerant Hydro delivery system features a hydrophilic coating, which attracts and holds water at the device surface to reduce friction. The coating is designed to aid navigation through the femoral and iliac arteries en route to the aorta.

"The combination of the Xcelerant Hydro delivery system and the Talent abdominal stent graft represents another major step forward for the treatment of patients with abdominal aortic aneurysms," commented Manish Mehta, MD. "The hydrophilic coating takes deliverability to a new level and gives endovascular interventionists greater control over the deployment of this excellent stent graft. Taken together, these technologies simplify the procedure and enhance patient care."

EVAR Reimbursements Found to Fall Short of 5-Year Costs
November 24, 2008—The Society for Vascular Surgery announced the publication of a study by investigators from the Ochsner Clinic Foundation that evaluated Medicare reimbursement of endovascular aneurysm repair (EVAR) compared to the cost of the procedure. The study by Jason K. Kim, MD, et al was published in the December 2008 issue of the Journal of Vascular Surgery (2008;48:1390–1395).

According to the investigators, the postplacement cost of surveillance and secondary procedures over 5 years increases the global cost of EVAR by nearly 50%. Therefore, the investigators conducted this study to identify and assess the reimbursement received for long-term postplacement costs after EVAR. The study was composed of 360 patients who underwent EVAR at a single institution (Ochsner) between December 1995 and June 2007. The reimbursement collected from charges of postplacement surveillance and secondary procedures related to the aneurysmal disease was evaluated and compared against the actual costs. All amounts were converted to year 2007 dollars. To minimize costs associated with the early learning curve, the initial 50 EVAR patients enrolled between December 1995 and 1998 were excluded. Patients with <1 year follow-up were also excluded. Data are expressed as mean ± standard error.

The investigators reported that the mean follow-up after EVAR for 152 patients was 38.8±1.8 months. Medicare, capitated insurance, and commercial insurance provided coverage for 85 (56%), 49 (32.2%), and 18 (11.8%) patients, respectively. The cumulative 5-year postplacement reimbursement received per patient was $9,792—meeting 81.4% of the cumulative cost of $12,027 for a net loss of $2,235 per patient. Although 123 (80.9%) patients without secondary procedures generated a 5-year cumulative gain of $1,830 per patient, 29 (19.1%) patients with secondary procedures averaged a 5-year cumulative loss of $9,378 per patient. The average reimbursement rate over the 5-year period was 35.8%±0.6%, with the lowest reimbursement rate seen in patients with Medicare at 31.6%±0.7%.

From these findings, the investigators concluded that current reimbursement is not sufficient to meet the costs associated with long-term surveillance and the need for secondary procedures after EVAR. Inadequate reimbursement of costs associated with secondary procedures was the primary driver for the net institutional loss. Reimbursement for outpatient radiological procedures generated a modest surplus, the investigators noted.

The investigators stated that improvements in technical skills, patient selection, endograft device durability, and endograft manufacturing (to decrease the incidence of endograft failure, migration, or endoleak) will be instrumental in decreasing the rate of secondary procedures and reduce the deficit between reimbursement and cost. Additionally, modifications to the surveillance protocol derived from ongoing review of evidence-based medicine may further help to reduce costs of long-term follow-up.

"Current reimbursement for long-term surveillance and secondary procedures after EVAR does not cover the institutional costs," commented lead investigator W. Charles Sternbergh III, MD. "This fiscal reality is not sustainable for our hospitals. If left uncorrected, this could ultimately result in a contraction of these resources and negatively affect patient outcomes."

Data Support Boston Scientific Neurovascular Devices
December 1, 2008—In Neurosurgery, Akira Ishii, MD, et al published findings from a single-center experience using first- and second-generation versions of Boston Scientific Corporation's (Natick, MA) Matrix bioabsorbable coils (2008;63:1071–1079). According to the investigators, the Matrix devices were developed to overcome the problem of recanalization after coil embolization of cerebral aneurysms, which remains a limitation of this progressively accepted modality.

As detailed in Neurosurgery, immediate and midterm angiographic outcomes of 235 consecutive patients with 250 aneurysms treated with Matrix coils were reviewed retrospectively. The first 16 aneurysms included in the postmarket ACTIVE (Acceleration of Connective Tissue Formation in Endovascular Aneurysm Repair) study were treated exclusively with the Matrix coil, as per protocol. The next 234 aneurysms were treated in combination with bare platinum coils, stents, and the balloon-assisted technique. First-generation Matrix coils were used in 155 aneurysms (Matrix1 group), and second-generation Matrix coils were used in 79 aneurysms (Matrix2 group). Outcomes of the three groups were compared.

The investigators reported that immediate complete obliteration was achieved in 12.5% of the ACTIVE group aneurysms, 32.9% of the Matrix1 group, and 43% of the Matrix2 group. Overall, 87 (34.8%) aneurysms were completely occluded acutely. Procedure-related morbidity and mortality rates were 2.4% and 0%, respectively. Follow-up (median, 7.9 months) angiograms were obtained for 186 (74.4%) aneurysms. Complete obliteration of aneurysms was confirmed in 26.7% of the ACTIVE group, 53.4% of the Matrix1 group, and 64.2% of the Matrix2 group. Recanalization was observed in 33.3% of the ACTIVE group, 16.9% of the Matrix1 group, and 9.4% of the Matrix2 group. The overall recanalization rate was 16.1%.

The investigators concluded that use of Matrix2 coils resulted in improved mechanical performance and anatomic outcome compared with Matrix1 coils; however, they advised that interventionists must be familiar with the mechanical characteristics of the Matrix coils, which are different from those of bare platinum coils.

On November 27, a small study by Michael E. Kelly, MD, et al was published online ahead of print in Neurosurgery that concluded that symptomatic subacute occlusions of intracranial arteries may be revascularized using Boston Scientific's Wingspan stent system in selected patients.

According to the investigators, collateral circulation in some patients may preserve the viability of brain parenchyma distal to an intracranial arterial occlusion for hours or days after the presenting event. These patients may be good candidates for revascularization, even when they present outside of the accepted 6-hour time window for stroke intervention. In the study, three patients were revascularized with the Wingspan stent system after presenting with subacute occlusions of intracranial arteries and progressive ischemic symptoms despite maximal medical therapy. All pre- and postprocedural imaging data and clinical records were reviewed. The investigators reported that three patients (mean age, 64 years; two women, one man) presented with symptomatic intracranial occlusions of the internal carotid artery (n=2) and vertebrobasilar system (n=1). All three patients presented >6 hours after symptom onset, and no intravenous or intra-arterial thrombolysis had been instituted. In all cases, despite supportive medical therapy (anticoagulation and antiplatelet therapy and induced hypertension), the patients continued to demonstrate progressive ischemia, both clinically and on diffusion magnetic resonance imaging. All patients were successfully revascularized without periprocedural complications and improved clinically after revascularization, stated the investigators.

Abciximab Studied for Intracranial Aneurysm Coiling
December 15, 2008—In Neuroradiology, Jan Gralla, MD, et al concluded that abciximab is efficacious and safe for thrombolysis during and after endovascular intracranial aneurysm treatment in the absence of preexisting ischemic stroke (2008;50:1041–1047). The study was conducted in light of the fact that thrombotic events are a common and severe complication of endovascular aneurysm treatment with significant impact on patients' outcome.

As detailed in Neuroradiology, the investigators evaluated risk factors for thrombus formation and assessed the efficacy and safety of abciximab for clot dissolution. Data of all patients treated with abciximab during (41 patients) or shortly after (22 patients) intracranial aneurysm coil embolization were retrieved from the institutional database (2000–2007, 1,250 patients). Sixty-three patients (mean age, 55.3±12.8 years) had received either intra-arterial or intravenous abciximab. Risk factors for clot formation were assessed, and the angiographic and clinical outcome was evaluated.

The investigators found that no aneurysm rupture occurred during or after abciximab application. The intraprocedural rate of total recanalization was 68.3%. Thromboembolic complications were frequently found in aneurysms of the Acom complex and of the basilar artery, whereas internal carotid artery aneurysms were underrepresented. Two patients died of treatment-related intracranial hemorrhages into preexisting cerebral infarcts, and two other patients developed a symptomatic groin hematoma, the investigators reported.

VEITH Presentation Suggests Statins Be Used With EVAR
November 22, 2008—At the VEITH Symposium in New York City, Jacob Buth, MD, presented findings that suggest that in the management of patients with abdominal aortic aneurysms (AAAs) >5.5 cm in diameter, initial treatment should be focused on minimizing the risk of the procedure. With an endovascular aneurysm repair (EVAR), persisting expansion and sometimes rupture of the aneurysm cannot always be prevented. Therefore, medical management of EVAR-treated patients should be targeted on stabilizing the aneurysmal wall, stated Dr. Buth.

According to Dr. Buth, the effect of statins has been the subject of extensive experimental and clinical investigation during the last decade. In addition to effectively reducing atherogenic lipoproteins, statins demonstrated additional biological action (ie, pleiotropic effects), which include inhibition of inflammatory activity and protease inhibition in the arterial wall. Dr. Buth commented that there is growing evidence that statins are independently associated with the reduction of aneurysmal growth rate in patients who do not undergo EVAR or open surgery but who are followed closely with serial ultrasound exams. It is accepted that statin therapy is clearly important in the management of coronary artery disease and peripheral vascular disease, Dr. Buth said, and now it appears from some studies that the effects of these drugs might translate to aneurysm treatment. Further research is still necessary to decide on the appropriate timing and dose of statin therapy for this patient population, Dr. Buth stated.

FDA Approves Endologix's IntuiTrak Delivery System
October 22, 2008—Endologix, Inc. (Irvine, CA) announced FDA approval of the IntuiTrak delivery system for the minimally invasive delivery and deployment of the Powerlink stent graft during endovascular abdominal aortic aneurysm (AAA) repair (EVAR). The company plans to conduct a limited market release over the next several months and expects a full commercial launch in the US in the second quarter of 2009.

According to the company, the IntuiTrak's design and deployment mechanism simplify delivery of the unibody bifurcated Powerlink device. The low-profile delivery system features enhanced flexibility, advanced hemostasis control, and a hydrophilic coating to facilitate smooth delivery, particularly in patients with limited or difficult vascular access. The delivery catheter has an integrated sheath to facilitate the introduction of ancillary devices during EVAR. This feature avoids the need for exchanges, thereby having the potential to reduce procedure time, blood loss, and minimize vessel trauma, the company stated.

On October 17, Endologix announced FDA approval of the premarket approval supplement for its Powerlink XL system, which includes new suprarenal stent grafts as well as the new Powerlink XL stent graft. This approval substantially broadens the EVAR treatment indications for the Powerlink System. The company stated that the Powerlink XL System was evaluated in an investigational device exemption clinical study and approved for the treatment of AAA patients with proximal aortic necks between 23 and 32 mm. Endologix noted that approximately 15% of EVAR procedures are performed in patients with aortic necks >26 mm. The low-profile Powerlink XL system allows for the treatment of AAAs in patients with limited or difficult vascular access. The Powerlink and Powerlink XL systems have proximal extensions in both infrarenal and suprarenal configurations to treat a wide range of patient anatomies, said the company.

REACH Registry Studies Risk Profile in AAA Patients
September 29, 2008—In the Journal of Vascular Surgery, Iris Baumgartner, MD, et al published data from the Reduction of Atherothrombosis for Continued Health (REACH) Registry (2008;48:808-814). The investigators' aim was to obtain data on the risk-factor profile and cardiovascular comorbidity among multi-ethnic patients with known abdominal aortic aneurysms (AAA) in the global REACH registry. The investigators stated that datasets regarding AAA patients have almost universally been restricted to single geographic regions.

As detailed in the Journal of Vascular Surgery, REACH is an international, prospective, observational outpatient registry enrolling outpatients ≥45 years of age with established coronary artery disease (CAD), cerebrovascular disease (CVD), peripheral arterial disease (PAD), or with at least three atherothrombotic risk factors. The report includes observations pertaining to 68,236 outpatients enrolled in 44 countries. Gender, ethnic origin, cardiovascular risk factors, established atherosclerotic disease (CAD, CVD, and PAD) at baseline, and cardiovascular outcome events at 1 year were compared in patients with and without AAA.

AAA was reported in 1,722 (2.5%) of 68,236 outpatients enrolled in the REACH registry. Older age (73±8 vs 68±10; P<.0001), male gender (81% vs 63%; P<.0001), white ethnicity (79% vs 67%; P<.0001), and a history of smoking (81% vs 55%; P<.0001) were independently related to the diagnosis of AAA. There was a weaker association with hypertension or hypercholesterolemia, and an inverse relation with diabetes. Fatal and nonfatal coronary and cerebrovascular event rates were not different between the AAA and non-AAA cohorts, but individuals with AAA experienced increased rates of other cardiovascular deaths (1.39% vs 0.94%; P=.0135), hospitalizations for atherothrombotic events (14.1% vs 9.3%; P<.0001) due to increased rates of revascularization procedures, and new or worsening PAD (3.7% vs 1.3%; P<.0001) at 1-year follow-up.

The investigators concluded that this study, the largest published to date, presents the cardiovascular risk profile and outcome of patients with an established diagnosis of AAA from a cohort of patients with either overt manifestations of cardiovascular disease or multiple risk factors and further defines these patients in a multiethnic, global context.

Study Supports EVAR Over Surgery in High-Risk Patients
September 29, 2008—The Society for Vascular Surgery (SVS) announced that 1-year data from a study by Jean-Eric Tarride, PhD, et al published in the October issue of the Journal of Vascular Surgery demonstrated that endovascular aneurysm repair (EVAR) yields better results than open surgical repair (OSR) in high-risk patients with similar costs (2008;28:779-787). The study was conducted at the request of the Ontario Ministry of Health and Long-Term Care to provide evidence to the Ontario Health Technology Advisory Committee to support policy recommendations regarding the use of EVAR in the province, the SVS noted.

According to the SVS, data were collected from 342 patients who had an abdominal aortic aneurysm (AAA) >5.5 cm and required elective AAA repair at London Health Sciences Center in London, Ontario, where EVAR has been used since 1997. Of the 192 patients at a high risk of postoperative complications, 140 underwent EVAR and 52 had OSR. The 1-year nonrandomized prospective study collected demographic, medical, healthcare-resource utilization, cost, and quality-of-life data to determine incremental costs and effects associated with each of these procedures. Sensitivity analyses were conducted to extrapolate the 1-year mortality results to a 5-year time horizon under various assumptions regarding convergence of mortality rates and reintervention rates (for EVAR patients only).

Ruptured AAA Outcomes in US Improved by EVAR
October 30, 2008—In the Journal of Vascular Surgery, two related studies have been published that investigated the treatment of ruptured abdominal aortic aneurysms (rAAAs) in the US.

The first study by Natalia Egorova, PhD, et al compared national outcomes of the treatment of rAAAs by open (OAR) versus endovascular (EVAR) aneurysm repair (2008;48:1092-1100). The investigators noted that EVAR of rAAAs has been shown to acutely decrease procedural mortality compared to OAR; however, little is known about either the effect of choice of procedure or the impact of physician and institution volume on long-term survival and outcome.

In the study, patients hospitalized with rAAA who underwent either OAR or EVAR, were derived from the Medicare inpatient dataset (1995–2004) using ICD9 codes. The investigators evaluated long-term survival after OAR and EVAR in the entire fee-for-service Medicare population and then in patients matched by propensity score to create two similar cohorts for comparison with Kaplan-Meier analysis. Annual surgeon and hospital volumes of EVAR (elective and ruptured), OAR (elective and ruptured), and rAAA (EVAR and OAR) were divided into quintiles to determine if increasing volumes correlate with decreasing mortality. Predictors of survival were determined by Cox modeling.

The investigators reported that 43,033 Medicare beneficiaries had rAAA repair: 41,969 had OAR and 1,064 had EVAR. The proportions of patients with diabetes, hypertension, cardiovascular, cerebrovascular, renal disease, hyperlipidemia, and cancer were statistically higher in the EVAR group than in the OAR group, whereas lower extremity vascular disease was higher in the OAR group. The initial evaluation of EVAR versus OAR, before propensity matching, showed no statistical advantage in EVAR survival after 90 days. The survival analysis of patients matched by propensity score showed a benefit of EVAR over OAR that persisted throughout the 4 years of follow-up (P=.0042). Perioperative and long-term survival after rAAA repair correlated with increasing annual surgeon and hospital volume in OAR and EVAR and also with rAAA experience. EVAR repair had a protective effect (hazard ratio=0.857; P=.0061) on long-term survival controlling for comorbidities, demographics, hospital volume, and surgeon volume.

The investigators concluded that when EVAR and OAR patients are compared using a reliable statistical technique such as propensity analysis, the perioperative survival advantage of endovascularly repaired rAAAs is maintained over the long term. Institutional experience with rAAAs is critical for survival after either OAR or EVAR, the investigators noted.

In the second study, Leila Mureebe, MD, et al evaluated trends in hospitalizations, treatment, and mortality of rAAAs in the US Medicare population (2008;48:1101-1107).

The investigators found that a significant decrease has occurred in the number of patients who have a diagnosis of rAAAs and undergo treatment, but there has been no change in repairs of AAAs. The perioperative mortality rate has improved due to the introduction of EVAR and a small but progressive improvement in survival after OAR for patients aged 65 to 74 years, the investigators concluded.

In this study, the investigators reviewed the Medicare inpatient database (1995–2006) for patients with rAAA and AAA based on International Classification of Disease (9th Clinical Modification) codes. Proportions and trends were analyzed by c2 analysis, continuous variables by t test, and trends by the Cochran-Armitage test.

According to the investigators, during the study period, hospitalizations with the diagnoses of rAAA declined from 23.2 to 12.8 per 100,000 Medicare beneficiaries (P<.0001), as did repairs of rAAA (from 15.6 to 8.4 per 100,000; P<.0001). No change was observed in AAA elective repairs. The 30-day mortality rate after OAR of rAAA decreased by 4.9% (from 39.6% to 34.7%; P=.0007 for trend) for the age group 65 to 74 years and by 2.4% (from 52.9% to 50.5%; P=.0008) for the age group ≥75 years. Perioperative mortality after EVAR was reduced by 13.6% (from 43.5% in 2001 to 29.9% in 2006; P=.0020). Mortality among women was higher than among men (51.1% vs 40% in 2006). The demographics of patients treated for rAAA changed to include a greater proportion of women and patients aged ≥75 years, reported the investigators.

Endovascular Treatment of TICAs Studied
September 23, 2008—In Neurosurgery, results of early angiographic diagnosis and endovascular treatment of traumatic intracranial aneurysms (TICAs) were published by José E. Cohen, MD, et al (2008;63:476-486).

As detailed in Neurosurgery, from June 2002 to December 2006, diagnostic angiography was performed on patients with moderate-to-severe traumatic brain injury that involved a cranial base fracture or a penetrating brain injury with a tract from the penetrating agent that entered at the pterional area, went through the middle cerebral artery candelabra, and crossed the midline. TICAs were treated by various endovascular techniques during the same angiographic procedure. Thirty-four patients with traumatic brain injury underwent angiography (25 penetrating brain injuries, nine blunt injuries); 13 TICAs were diagnosed (10 penetrating brain injuries, three blunt injuries). The Glasgow Coma Scale score at diagnosis ranged from 5 to 15. Angiography was performed for screening in eight patients and for clinical indications in five patients; 11 TICAs were diagnosed before rupture. Seven aneurysms were located on branches of the middle cerebral artery, two were on the pericallosal branches of the anterior cerebral artery, and four were on the internal carotid artery. No recanalization was detected in 12 patients. One patient treated with a bare stent and coiling had a growing intracavernous pseudoaneurysm; therefore, internal carotid artery occlusion with extracranial-intracranial microvascular bypass was performed. Six patients refused angiographic follow-up, but computed tomographic angiography failed to show recanalization. No patient presented with delayed bleeding (mean follow-up, 2.6 years). There were no procedure-related complications or mortality, the investigators reported.

The investigators concluded that early angiographic diagnosis with immediate endovascular treatment provided an effective approach for TICA detection and management. Endovascular therapy is versatile and offers a valuable alternative to surgery, allowing early aneurysm exclusion with excellent results, the investigators stated.

VALOR Supports Medtronic's Talent Thoracic Stent Graft
August 28, 2008—The Society for Vascular Surgery (SVS) announced that Ronald M. Fairman, MD, et al published findings from the VALOR (Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms) trial in the September issue of its Journal of Vascular Surgery (2008;48:546-554). The findings demonstrated that the Talent thoracic stent graft system (Medtronic Vascular, Santa Rosa, CA) is a safe and effective endovascular therapy, as an alternative to open surgery in patients with thoracic aortic aneurysms who were considered candidates for open surgical repair. VALOR is a prospective, nonrandomized, multicenter, pivotal trial conducted at 38 sites. In the VALOR trial, 195 patients were enrolled, and 189 patients were identified as retrospective open-surgical subjects. Endovascular enrollment occurred between December 2003 and June 2005. Endovascular results were compared with retrospective open-surgical data from three centers of excellence.

According to the SVS, the mean number of Talent thoracic stent graft components implanted was 2.7±1.3 devices per patient. Of the proximal main Talent components implanted, 25% had diameters <26 mm or >40 mm. Left subclavian artery revascularization was performed before the initial stent graft procedure in 5.2% of patients, and iliac conduits were utilized in 21.1% of patients. Also, 33% of patients had the bare-spring segment of the most proximally implanted device in zones 1 or 2 of the aortic arch, and 194 patients (99.5%) had successful vessel access and deployment of the Talent device at the intended site.

The investigators reported that the 30-day VALOR results included perioperative mortality (2.1%), major adverse events (41%), incidence of paraplegia (1.5%), paraparesis (7.2%), and stroke (3.6%). The 12-month VALOR results included all-cause mortality (16.1%), aneurysm-related mortality (3.1%), conversion to open surgery (0.5%), target aneurysm rupture (0.5%), stent graft migration >10 mm (3.9%), endoleak (12.2%), stent graft patency (100%), stable or decreasing aneurysm diameter (91.5%), and loss of stent graft integrity (four patients). There were no instances of deployment-related events or perforation of the aorta by a graft component. The submission of these pivotal trial results led to FDA approval of the Talent thoracic stent graft system for treatment of thoracic aortic aneurysms in June 2008, the SVS noted.

"The Talent thoracic stent graft showed statistically superior performance with respect to acute procedural outcomes (P<.001), 30-day major adverse events (41% vs 84.4%; P<.001), perioperative mortality (2% vs 8%; P<.01), and 12-month aneurysm-related mortality (3.1% vs 11.6%; P<.002) when compared to open surgery," commented Dr. Fairman, National Principal Investigator of the VALOR trial.

Endologix's Powerlink 6-Year Data Published
August 28, 2008—In the Journal of Vascular Surgery, Grace J. Wang, MD, and Jeffrey P. Carpenter, MD, compared the results of treating abdominal aortic aneurysm (AAA) with endovascular repair (EVAR) using the Powerlink endovascular graft (Endologix, Inc., Irvine, CA) and conventional open surgical repair through a 6-year follow-up period (2008;48:535-545). The investigators concluded that 6-year follow-up of patients treated with the Powerlink system demonstrated the continued safety and efficacy of its treatment of AAA.

In the study, 258 patients with AAA were prospectively enrolled in a multicenter trial and underwent EVAR (n=192) or surgery (n=66). All endovascular repairs were approached through a surgically exposed and percutaneously accessed femoral artery. Study endpoints included all-cause mortality and morbidity. Follow-up imaging consisted of contrast-enhanced CT scans and plain abdominal x-rays at 1, 6, and 12 months, and annually postoperatively.

The investigators reported that technical success was achieved in 97.9% of test patients, with four failed insertions (three early conversions because of deployment issues, one access failure). Mean follow-up was 4.1±1.7 years (test group) and 3.1±1.9 years (control group). Perioperative morbidity and mortality rates were significantly reduced in the test group compared with the control group (P<.05). At 6 years, all-cause mortality and morbidity rates were no different in the Powerlink group compared with the open repair group. There were no reported stent fractures, graft disruptions, or aneurysm ruptures. Core laboratory-reported endoleaks included proximal or distal type I (n=1) and type I/II (n=3), with no type III or type IV endoleaks. One explant (0.5%) was undertaken to resolve a refractory type I endoleak. A total of 37 secondary procedures were performed in 26 patients to treat site-reported endoleak (n=26; seven for type I and 19 for type II), graft limb occlusion (n=7), native artery occlusion (n=3), or endograft migration (n=1). A reduction in mean aneurysm sac diameters and volumes has been noted at every follow-up interval. Consistent with other reports, perioperative morbidity and mortality rates were significantly reduced in the endovascular group compared with the open-repair group.

Cook Medical's Zenith AAA Iliac Flex Legs Approved
August 4, 2008—Cook Medical (Bloomington, IN) announced FDA approval to market its improved Zenith abdominal aortic aneurysm (AAA) Iliac Flex Legs and Z-Trak introduction system, made for use with the Zenith Flex AAA endovascular graft. The products are designed specifically to provide increased flexibility and improved conformability in the aorta and iliac artery, a tortuous section of patient anatomy, for patients undergoing endovascular aneurysm repair (EVAR). The Cook Zenith AAA Flex Legs and Z-Trak introduction system are available in the US, UK, and continental Europe. On July 14, Cook Medical announced the launch of the CE Mark-approved Zenith AAA Iliac Legs with Flex Stent Gapping.

According to the company, the Zenith AAA Flex Leg external stents are shorter than those of Cook Medical's previous device, with increased gaps between the stents. This design improves flexibility and conformability, reducing the potential of the leg to kink. The device, like the Zenith Flex main body, is constructed of polyester graft material supported by stainless steel Z-stent bodies. The Zenith Flex endograft main body with Flex Leg stents represents an important engineering achievement in the pursuit of improved outcomes for patients undergoing EVAR.

Cook Medical stated that its Z-Trak introduction system provides an integrated interface to the Zenith, with precise, controllable device orientation and deployment of the company's endovascular stent graft. Precision allows the interventionist to make last-minute adjustments before deployment of the stent graft. The trigger-wire delivery mechanism allows adjustment of the endograft in a semideployed state for accuracy.

EVAR Compared to Surgery in Thoracoabdominal Treatment
August 4, 2008—Roy K. Greenberg, MD, et al have published online ahead of print in Circulation at http://circ.ahajournals.org, a contemporary analysis of descending thoracic and thoracoabdominal aneurysm treatments that compared endovascular aneurysm repair (EVAR) and open surgical techniques. The study investigators are from the Cleveland Clinic Foundation. According to the investigators, the background of the study is that although thoracic EVAR has demonstrated low risks of mortality and spinal cord ischemia (SCI), few large series have been published on thoracoabdominal EVAR, and reports suffer from a lack of accurate comparison with similar open surgical procedures.

The investigators concluded that no significant difference in the incidence of mortality or SCI was found between EVAR and open surgical techniques. The strongest factor associated with SCI remains the extent of the disease. Further studies are indicated to compare EVAR with patients considered eligible for open surgical repair, the investigators stated.

As detailed in Circulation, the study analyzed a consecutive cohort of patients with thoracic and thoracoabdominal aneurysms treated electively with EVAR or open surgical repair techniques between 2001 and 2006 at the Cleveland Clinic. The association between repair technique and SCI was evaluated with univariable analysis. Adjustments for potential confounders and for the propensity to undergo EVAR or open repair were also performed in multivariable analysis. A total of 724 patients (352 EVAR, 372 open) underwent repair. The mean age of patients was 67 years, and 65% were male. EVAR patients were on average 9 years older (P<.001), had more comorbid conditions, and more frequently had previous distal repair (P<.001) or underwent a type I or IV repair. Open surgical repair patients more commonly had chronic dissection or required type II or type III repairs (P<.001).

The investigators found that mortality rates were similar at 30 days (5.7% EVAR vs 8.3% open; P=.2) and 12 months (15.6% EVAR vs 15.9% open; P=.9). A borderline difference in SCI was found between repair techniques: 4.3% of EVAR patients and 7.5% of open surgical patients (P=.08) had SCI. In EVAR patients, prior distal aortic operation was associated with the development of SCI in univariable analysis (odds ratio, 4.1; 95% confidence interval, 1.4–11.7). Multivariable analysis showed that the type of required repair (type I, II, III, or IV) was the primary factor associated with the development of SCI in EVAR and open surgical patients, the investigators reported.

According to the Cleveland Clinic, the study is the first to compare outcomes for the EVAR versus surgical repair of aneurysms involving both the thoracic and abdominal area. It noted that the procedures were found to have similar clinical outcomes despite the more severe comorbid disease in patients treated with EVAR. The Cleveland Clinic stated that it is the only medical institution in the country where both the EVAR and surgical repair techniques are commonly used to treat aneurysms involving both the thoracic and abdominal segments. The EVAR patients in this study were participants in clinical research trials, and the devices that were used are currently investigational and are not commercially available in the US, the Cleveland Clinic advised.

"This study can serve as a basis for patients with complex aneurysms who have not previously been considered candidates for EVAR," commented Dr. Greenberg. "Despite the higher-than-average age and the complex conditions of the patients treated with EVAR, we were able to achieve results similar to those of a more invasive surgery with respect to possible complications."

Zenith Investigators Call for Redefined Post-EVAR Regimen
July 22, 2008—In the August issue of the Journal of Vascular Surgery, W. Charles Sternbergh III, MD, et al, for the Zenith Investigators, published recommendations for redefining postoperative surveillance after endovascular aneurysm repair (EVAR) (2008;48:278-285). The recommendations are based on the 5-year follow-up in the US multicenter trial of the Zenith endovascular graft (Cook Medical, Bloomington, IN) that was reported in the July issue of the Journal of Vascular Surgery (2008;48:1-9).

According to the Zenith investigators, the current recommended postoperative surveillance after EVAR includes serial contrast-enhanced computed tomography scans. The cumulative deleterious effect on renal function, the radiation exposure, and the significant cost of this surveillance regimen are all problematic. However, there are scant data to support modulation of current post-EVAR surveillance regimens.

The Zenith study comprised patients who underwent EVAR as part of the prospective multicenter pivotal (phase 2) and continued-access (phase 3) US Zenith endovascular graft trials. A core lab prospectively recorded patient data. A composite aneurysm-related morbidity (ARM) variable was calculated to include aneurysm ruptures, open conversions, any secondary interventions, limb thromboses, migrations, renal morbidities, or aneurysm-related deaths. The long-term freedom from ARM as a function of the presence or cumulative absence of any endoleak at 1, 6, and 12 months was analyzed. The potential additive predictive utility of aneurysm sac shrinkage (≥5 mm) was assessed at 12 months. The instructions for use for aortic neck anatomy (≥15-mm length, 18- to 28-mm diameter, ≤60° angulation) were followed.

The investigators reported that EVAR was performed in 739 patients (mean follow-up, 29.9±17.1 months). Freedom from endoleak at 1 month was highly predictive (P<.001) of reduced ARM: freedom from ARM was 92.3%, 89.8%, 85.2%, 83.1%, and 83.1% at 1, 2, 3, 4, and 5 years, respectively, in patients without endoleak (83.1%) and 75%, 67.1%, 61.5%, 55.9%, and 55.9% in patients with endoleak (16.9%). Cumulative absence of endoleak at 1 year (77.6%) was associated with 94%, 91.5%, 88.1%, 85.8%, and 85.8% 1- to 5-year freedom from ARM versus 73.3%, 66.7%, 56.6%, 52.5%, and 52.5% in patients with endoleak ≤1 year (22.4%; P<.001). In patients without endoleak at 12 months, the subsequent risk of any ARM was 8.2% (5-year risk, 14.2%; 1-year risk, 6%). In patients with significant sac shrinkage (≥5 mm) and cumulative absence of endoleak at 12 months, the subsequent risk of an ARM was 5.3% (5-year risk, 11.1%; 1-year risk, 5.8%). Absence of endoleak at 30 and 365 days predicted greatly improved long-term freedom from ARM compared with early endoleak.

The Zenith investigators recommended a new EVAR surveillance regimen that modulates the intensity and frequency of postoperative imaging based on these early outcomes. In patients without early endoleak, the 6-month surveillance is eliminated, and aortic ultrasound is suggested for long-term surveillance >1 year. In most patients, this reduced surveillance regimen would be appropriate and could improve patient safety by reducing the cumulative deleterious effects of intravenous contrast and radiation exposure while also reducing health care costs. These subjective recommendations would be ideally validated in a randomized, prospective trial, the investigators concluded.

ATENA Study Indicates Feasibility of Intracranial EVAR
July 10, 2008—According to a study by Laurent Pierot, MD, PhD, et al published online ahead of print in Stroke at http://stroke.ahajournals.org, the management of unruptured intracranial aneurysms remains controversial, and the results of endovascular treatment are not precisely known because no prospective data exist. Therefore, the investigators conducted ATENA (Aneurysms Treated by Endovascular Approach), the first prospective multicenter study in Canada and France to determine the clinical outcome and risks of this treatment.

As reported in Stroke, in the ATENA study, 649 patients with a total of 1,100 aneurysms from 27 Canadian and French neurointerventional centers were prospectively and consecutively treated by endovascular coil embolization. Of these, 739 unruptured intracranial aneurysms were treated during 700 procedures. Aneurysms were selectively treated in the great majority of cases (98.4%) with coils alone (54.5%), the balloon remodeling technique (37.3%), or stenting (7.8%). The investigators found that endovascular treatment failed in 32 aneurysms (4.3%). Technical adverse events with or without clinical modification were encountered in 15.4% of patients and included thromboembolic complications (7.1% per procedure), intraoperative rupture (2.6% per procedure), and device-related problems (2.9% per procedure). Adverse events associated with transient or permanent neurological deficits or deaths were encountered in 5.4% of cases. The 1-month morbidity and mortality rates were 1.7% and 1.4%, respectively. These data indicate that the endovascular treatment of unruptured intracranial aneurysms is feasible in a high percentage of patients with low morbidity and mortality rates, the investigators concluded.

EU Approves Medtronic's Endurant AAA Stent Graft
July 7, 2008—Medtronic Vascular (Santa Rosa, CA) announced that the Endurant abdominal stent graft system received CE mark approval for endovascular aortic repair (EVAR) of abdominal aortic aneurysms (AAAs). The device is being launched outside the US in mid-July. According to the company, the Endurant addresses AAA patients whose aortas are highly angulated or whose aneurysms have short necks. Professor Hence Verhagen, MD, PhD, led the Endurant's European clinical trial, which supported the CE Mark.

The company also announced the commencement of enrollment in the US clinical trial of the Endurant stent graft system. The FDA approved the US clinical trial in June under an investigational device exemption. Michel Makaroun, MD, is the US trial's principal investigator. The trial is designed to evaluate the Endurant's safety and effectiveness in the endovascular treatment of AAAs. This pivotal trial will be used to seek FDA approval of the device. The study will enroll 150 patients at up to 30 US sites in the next 12 to 18 months. All patients who meet the single-arm study's inclusion criteria will receive an Endurant stent graft. Their outcomes will be compared to those who received Medtronic's Talent abdominal stent graft as part of the pivotal study that led to that device's FDA approval in April. The first implants of the Endurant in the US clinical trial were performed recently with excellent periprocedural results, said the company.

Micrus's Intracranial Stent Approved in Europe
June 23, 2008—Micrus Endovascular Corporation (San Jose, CA) announced that its Pharos Vitesse intracranial balloon-expandable stent has received CE Mark approval for the treatment of intracranial ischemic stenosis and wide-neck aneurysms. The company is commencing an immediate market launch in the EU. The Pharos Vitesse is manufactured exclusively for Micrus Endovascular through a collaborative agreement with Biotronik AG (BÙlach, Switzerland). According to the company, the device enables the intracranial delivery and deployment of a stent in one step, thereby eliminating the need for predilation of constricted vasculature. The Pharos Vitesse features include a longer, softer distal tip; a newly designed, thinner balloon; Micrus's rapid-exchange delivery system; and a proprietary coating that may reduce the need for retreatment due to restenosis. Micrus has applied for an FDA investigational device exemption to initiate a randomized, prospective, clinical trial for the Pharos Vitesse for the treatment of neurovascular stenoses.

On July 10, Micrus announced receipt of Shonin approval from the Ministry of Health, Labour and Welfare to market in Japan its Cerecyte microcoil product line, including the MicruSphere, Presidio, HeliPaq and UltiPaq Cerecyte embolic coils, for the endovascular treatment of cerebral aneurysms.

Cook Medical Announces Zenith AAA Stent Graft Data
June 25, 2008—Cook Medical (Bloomington, IN) announced that a nonrandomized, controlled study by Roy K. Greenberg, MD, et al generated positive results on the Cook Zenith abdominal aortic aneurysm (AAA) endovascular graft for endovascular aortic repair (EVAR). According to the company, the trial results indicated that EVAR using the Cook Zenith is a safe and effective alternative to open surgical repair for the treatment of AAAs. The results were presented on June 6 at the annual meeting of the Society for Vascular Surgery in San Diego, California, and were published in the Journal of Vascular Surgery (2008;48:1-9).

Dr. Greenberg, along with trial investigators Timothy A. Chuter, MD, Richard P. Cambria, MD, and W. Charles Sternbergh III, MD, presented 5-year data on 739 patients in the multicenter trial. The study compared EVAR using the Cook Zenith device to a control group that underwent open surgical repair to treat AAAs. The mid- and long-term data found long-term durability, a significantly low risk of aneurysm-related death or rupture, and infrequent complications of migration, limb occlusion, and device integrity issues. Specifically, the study demonstrated that for Zenith patients at standard and high medical risk, aneurysm-related death was 2% and 4%; and freedom from rupture was 100% and 99.6%, respectively. Overall, the cumulative risk of conversion, limb occlusion, migration >10 mm, or component separation was ≤3% at 5 years. The Cook Zenith AAA Endovascular Graft 5-Year User Report is available online at www.cookmedical.com/ai.

Aptus's STAPLE-1 Presented at PVSS for EVAR Device
June 16, 2008—Aptus Endosystems, Inc. (Sunnyvale, CA) announced that David H. Deaton, MD, presented results of the STAPLE-1 multicenter clinical trial at the annual meeting of the Peripheral Vascular Surgery Society held on June 6 in conjunction with the Vascular Annual Meeting in San Diego, California. The STAPLE-1 clinical study evaluated the primary endpoints of safety and feasibility of the Aptus endograft and endostapling system in the endovascular repair (EVAR) of abdominal aortic aneurysms (AAAs). The device is a novel technology platform composed of a three-piece modular endograft with a flexible main body and two fully supported limbs delivered via a 16-F delivery system. Aptus EndoStaples are delivered through an independent endostapling system to approximate the durable outcomes of open surgical repair with a less-invasive procedure. Both the location and number of the EndoStaples are actively controlled by the interventionist and provide for a customized solution for endograft fixation and sealing depending on the anatomical challenges of the individual patient, the company stated.

The STAPLE-1 clinical study enrolled 21 patients at five centers in the US. Inclusion criteria incorporated standard indications for EVAR but with a proximal aortic neck length of 12 mm and iliac landing zone of 10 mm, allowing for the inclusion of patients who might not otherwise be indicated for treatment with some commercially available devices. The STAPLE-1 treatment group met its primary 30-day safety and feasibility endpoints, and all patients have been sequentially followed for 6 months. More than half of those have been followed up for more than 1 year. Secondary endpoints included freedom from endoleaks, rupture, and migration, as well as device integrity. No device migration of any length, and no type I, III, or IV endoleaks were detected in the patient population out to 1 year. Significant aneurysm reduction occurred in 43% of the population at 6 months and in 69% of patients at 1 year. No aneurysm enlargement was seen at 6 months or 1 year, the investigators found. The company stated that it is currently enrolling patients in the STAPLE-2 pivotal study of the Aptus AAA EVAR system at 25 centers in the US, with a goal of enrolling up to 155 treatment patients to demonstrate the safety and effectiveness of the system in a larger and broader population.

"These early results demonstrate a high degree of success with a new technology that has the promise of improving both acute and, more importantly, long-term outcomes of EVAR by creating a proximal fixation that mimics a hand-sewn anastomosis," commented Dr. Deaton.

Long-Term TEVAR Data Published for Zenith TX
July 1, 2008—In the Journal of Vascular Surgery, Jose P. Morales, MD, et al have published a study of the durability and long-term results with the Zenith TX1 and TX2 thoracic devices (Cook Medical, Bloomington, IN) in high-risk patients (2008;48:54-63).

Noting that little data exist to support the durability of thoracic endovascular repair during prolonged periods of follow-up, the investigators prospectively collected data from 2001 to 2007 on high-risk patients who presented with thoracic aneurysms, chronic aortic dissection, or fistulas treated with a Zenith thoracic device. Surgical modifications of proximal or distal landing zones were performed when necessary. Computed tomography follow-up scans were performed before discharge, at 1, 6, and 12 months, and yearly thereafter. Three-dimensional reconstruction software with a central line of flow measurements was used to assess aortic morphologic characteristics. Kaplan-Meier analysis was used to assess survival, freedom from reintervention, predictive factors of poor outcome, and morphologic changes, including aneurysm sac behavior.

The investigators reported that a total of 160 patients (44% women; mean age, 70) were treated for 130 thoracic aneurysms, 25 aortic dissections with aneurysm, two fistulas, and three symptomatic or aortic ruptures, or both. Mean follow-up was 36 months, and aneurysm size was 67 mm. Seventy-five patients (47%) had undergone previous aortic aneurysm repair. Surgical modifications were required to create adequate landing zones in 33% patients, including 28 elephant trunk/arch reconstruction, 22 carotid-subclavian bypasses, and seven visceral vessel bypasses. Iliac conduits were required in 31 patients. Early mortality (<30 days) occurred in 11 patients (6.9%). The overall mortality rate at 1 year was 16%. Aneurysm sac increase (>5 mm) requiring intervention was observed only in one patient in the settings of component separation and type III endoleak that was treated; the sac is now stable. Twenty-seven endoleaks were detected in 25 patients: 15 primary endoleaks (9.4%) <30 days and 12 secondary endoleaks (7.5%) >30 days. Secondary interventions were required in 42 patients (26%). From these data, the investigators concluded that endovascular treatment of thoracic aortic pathologies with the Zenith TX1 and TX2 devices is feasible and durable. The mid- to long-term results are encouraging, with acceptable low reintervention rates and with good survival within high-risk patients.

On June 24, Cook Medical announced the first commercial placement in the US of its Zenith TX2 thoracic aortic aneurysm endovascular graft. The device received FDA approval on May 23. Sean Lyden, MD, performed the 45-minute procedure on a 69-year-old man.

"The two-piece device allowed customization to the patient's anatomy to sit perfectly at the level of the left subclavian artery proximally and distally to near the celiac artery and prior repair," commented Dr. Lyden. "The hydrophilic Flexor delivery system passed through his anatomy to the treatment area with remarkable ease."

FDA Approves Medtronic's Talent Thoracic Stent Graft
June 5, 2008—Medtronic Vascular (Santa Rosa, CA) announced FDA approval for the Talent thoracic stent graft for the endovascular repair of aneurysms of the descending thoracic aorta. With a range of 22-mm to 46-mm diameters, the device makes thoracic endovascular aortic repair (TEVAR) accessible to an additional 25% of patients and offers interventionists multiple options to customize devices to the needs of patients and a wider range of anatomies. Ronald Fairman, MD, was Principal Investigator of the Medtronic-sponsored VALOR (Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms) clinical trial.

According to Medtronic, 195 patients were enrolled in the VALOR trial at 38 medical centers between December 2003 and June 2005. All 195 patients received a Talent thoracic stent graft, and their outcomes were compared to 189 open surgical control patients at three centers of excellence who matched selected inclusion/exclusion criteria of the VALOR trial. The Talent group met its primary safety and efficacy endpoints, with an all-cause mortality rate of 16.1% and a successful aneurysm treatment rate of 89.2% at 12 months. In the VALOR trial, the 30-day mortality rate was 2.1%, and the aneurysm-related mortality rate at 12 months was 3.1%. The VALOR data show that TEVAR with the Talent thoracic system resulted in lower mortality than open surgery, as well as low rates of morbidity and device-related adverse events, the company stated.

Gore's TAG Endoprosthesis Approved in Japan for TEVAR
June 5, 2008—Gore & Associates, Inc. (Flagstaff, AZ) announced that it has received regulatory clearance from the Japanese Ministry of Health, Labor, and Welfare to market the Gore TAG thoracic endoprosthesis for the treatment of aneurysms of the descending thoracic aorta. The first postapproval procedure using the device in Japan was conducted by Toru Kuratani, MD, at Osaka University who was supported by Takao Ohki, MD, who has a significant amount of experience with the device. The 1-hour procedure went very smoothly, the company said.

The company noted that the Gore TAG was designated as the highest priority device for expedited regulatory review by the various physician societies in Japan. In the US, the Gore TAG was approved in March 2005. In January 2007, the company received regulatory clearance to market the Gore Excluder AAA endoprosthesis in Japan for the endovascular treatment of abdominal aortic aneurysms.

According to Gore, the TAG device is an extremely flexible ePTFE graft with an outer self-expanding nitinol support structure. In the Gore TAG's pivotal study comparing the device to open surgical repair, patients treated with the endoprosthesis experienced fewer complications, significantly less procedural blood loss, shortened hospital stays, and a two times faster return to normal activity than those treated with open surgery. Through 5 years of follow-up, patients treated with the Gore TAG device experienced a significantly lower incidence of major adverse events and improved aneurysm-related survival than patients treated with open surgery, the company stated.

EVAR of Ruptured Thoracic Aneurysms Reduces Mortality
June 5, 2008—At the Vascular Annual Meeting in San Diego, California, a study of endovascular repair of ruptured thoracic aortic aneurysms (r-TAAs) was associated with markedly reduced mortality and improved midterm survival, when compared to open surgical approach in a prospective intent-to-treat longitudinal study. Treatment and postoperative care, surgical repair of r-TAAs has continued to have a high morbidity and mortality rates despite improvements in perioperative diagnosis.

Manish Mehta, MD, presented findings of a study of 121 patients who presented emergently with r-TAAs since 2001 at The Vascular Institute for Health and Disease at Albany Medical Center. Of these patients, 43% underwent emergent thoracic endovascular aneurysm repair (TEVAR), and 57% had emergent open surgical repair. Compared to the open surgical group, the endovascular patients had significantly higher pre-existing defined comorbidities, including coronary artery disease (47% vs 17%), hypertension (69% vs 30%), chronic obstructive pulmonary disease (21% vs 4%), and chronic renal insufficiency (16% vs 4%). Neurological complications, including paraplegia and stroke, occurred more frequently in the open group (16% vs 5%). Over a mean follow-up of 15 months, 11% of the patients in the endovascular group and 16% of the patients in the open surgical group required secondary adjunctive procedures.

According to Dr. Mehta, use of endovascular techniques for emergent treatment of r-TAA increased annually from 29% in 2005 to 67% in 2006, and up to 90% in 2007. Before 2005, open surgical repair of r-TAA was the primary treatment of choice. The surgeons at the Vascular Institute for Health and Disease stated that the ability to treat r-TAA by endovascular means has had a significant impact on improving patient survival.

"The life table analysis indicated the cumulative survival in the endovascular group to be significantly better than the open surgical group at 30 days (71% vs 44%), at 1 year (51% vs 33%), at 2 years (45% vs 33%), and at 3 years (45% vs 26%)," observed Dr. Mehta. "Besides improving on the morbidity and mortality of these complex high-risk procedures, with an endovascular approach, we can expand on offering this treatment to patients with significant comorbidities who might otherwise be left untreated."

EVAR Approval Resulted in Decrease of Total AAA Deaths
June 5, 2008—At the Vascular Annual Meeting in San Diego, California, Kristina Giles, MD, reported that, in the US population, deaths from all abdominal aortic aneurysms (AAAs) as well as the total number of ruptured AAAs is declining, whereas the number of elective repairs is increasing. The findings were based on an analysis of nationwide database of hospital discharges from 1988Ð2005 conducted by Marc Schermerhorn, MD, and colleagues at Beth Israel Deaconess Medical Center in Boston. The database used in this study represented a 20% sample of national nonfederal hospital admissions (with sample weights allowing extrapolation to 100%) and the decreased mortality rates support the benefit of EVAR rather than open surgery in suitable patients. Dr. Schermerhorn noted before the meeting that these improved results coincide with the introduction of endovascular aneurysm repair (EVAR), approved by the FDA in 1999. According to the investigators, during the last 17 years, the average number of elective repairs performed annually has increased from 34,147 to 35,744. Conversely, the overall annual number of ruptures of AAAs decreased from 9,662 before the approval of EVAR to 7,017 after the approval of EVAR, and rupture repairs decreased from 6,607 to 4,617. The investigators calculated the deaths from elective repair, ruptured repair, and ruptured aneurysms without repair. The overall annual number of aneurysm-related deaths was 6,741 before the approval of EVAR (1988Ð1999) and 4,640 after the approval of EVAR (2000Ð2005). Patient mortality during the endovascular era decreased from 5,309 in 2000 to 3,949 in 2005. The average death rate after rupture repair dropped from 45% before the approval of EVAR to 41% after the approval of EVAR. After the approval of EVAR, the average number of annual deaths in each classification decreased as follows: elective AAA repair, from 1,598 to 1,136; ruptured AAA repair, from 2,978 to 1,875; and ruptured AAA without repair, from 2,238 to 1,629. Additionally, the overall mortality rate with elective repair has decreased after EVAR was introduced, from 4.7% to 3.2%, with an average mortality rate with EVAR of 1.4%. By comparison, the mortality rate of standard open surgical elective repair was 4.7% and declined to 4.5% after the approval of EVAR, the investigators noted.

Cerecyte Microcoil Studied to Treat Cerebral Aneurysms
June 5, 2008—Micrus Endovascular Corporation (San Jose, CA) announced the publication of positive data from two clinical studies evaluating the use of the company's bioactive Cerecyte microcoil in the treatment of cerebral aneurysms. Cerecyte platinum microcoils contain a polyglycolic acid filament that researchers suggest may accelerate the healing process, the company stated.

Erol Veznedaroglu, MD, et al published findings on the impact of the Micrus bioactive Cerecyte detachable coils on reducing recurrence rates in Neurosurgery (2008;62:799-806). In the study, the investigators evaluated 81 patients with 89 aneurysms treated exclusively with Cerecyte bioactive microcoils for safety, durability, and effectiveness on recanalization rates. Of the 89 aneurysms, 65% were ruptured, and the mean aneurysm size was 7 mm. Follow-up angiography at a mean of 11.2 months demonstrated a total recurrence rate of 10.7% and recurrences requiring retreatment of 6.7%.

"The Cerecyte bioactive coil seems safe and effective for use in both ruptured and unruptured aneurysms, and the fact that the bioactive polymer is located within the coil makes for handling characteristics similar to those of bare platinum coils," commented Dr. Veznedaroglu.

On May 16, Serdar Geyik, MD, et al published online ahead of print in Neuroradiology, "Endovascular Treatment of Intracranial Aneurysms With Bioactive Cerecyte Coils: Effects on Treatment Stability." The investigators evaluated midterm angiographic follow-up data to assess Cerecyte bioactive microcoils' durability and efficacy in preventing recanalization. The results were based on 78 patients with 84 intracranial aneurysms treated exclusively with Cerecyte bioactive coils. Of those 78 aneurysms, 48 were ruptured and 36 were incidental; 77 were small (<10 mm), six were large (10Ð25 mm), and one was giant (>25 mm). Follow-up angiography was obtained in 80 aneurysms over a 6-month to 2-year time period, with an overall recanalization rate of 11.3%. Procedure-related morbidity and mortality rates were 2.6% and 1.3%, respectively.

"Although our results provided an improved initial treatment success with relatively low complication and recurrence rates compared to those reported for bare-platinum coils, the effectiveness of Cerecyte bioactive coils in preventing aneurysm recurrence remains to be proven by the ongoing controlled, multicenter, randomized CERECYTE trial," commented investigator Saruhan Cekirge, MD. The company expects further clinical data to be published from individual clinical series, as well as the results from the company's 500-patient CERECYTE prospective, randomized trial conducted by Andrew J. Molyneux, MD.

Cook Announces FIM Use of Zenith Low Profile Endograft
June 3, 2008—Cook Medical (Bloomington, IN) announced the first-in-man use of the company's Zenith Low Profile AAA endograft system for the treatment of abdominal aortic aneurysms. The radically smaller system has been simplified to eliminate the top cap and uses more highly compressible Z-stent bodies instead of the existing stents used in the current Zenith Flex endografts and features a 16-F delivery sheath. If proven safe and effective in an upcoming clinical trial, Cook's miniaturized device could open endovascular treatment of aneurysms to a new class of patients who currently have only open surgery as a treatment option due to the small diameter of their blood vessels and other anatomic issues. In addition, it may enable physicians to eliminate the need for a surgical cutdown to access the femoral artery and allow the use of the percutaneous entry technique with less trauma, the company stated.

Cook Medical's Zenith TX2 TEVAR Graft Approved by FDA
May 23, 2008—Cook Medical (Bloomington, IN) announced it has received FDA approval for its Zenith TX2 thoracic aortic aneurysm (TAA) endovascular graft. The Zenith TX2 is indicated to treat patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair (TEVAR). Approval for the device indication was based on the 12-month results of Cook's multinational STARZ-TX2 clinical trial, the results of which indicated that TEVAR with the Zenith TX2 is a safe and effective alternative to open surgical repair for the treatment of TAAs in patients with suitable anatomy. The Cook Zenith TX2 includes an uncovered distal stent with fixation barbs to hold the device in place. The device relieves pressure on the aneurysm, reduces the risk of rupture, and in most cases, allows the aneurysmal sac to shrink, the company stated.

FDA Reinforces Need for Continued Surveillance of EVAR Patients
March 17, 2008—Daniel G. Schultz, MD, the Director of the FDA's Center for Devices and Radiological Health (CDRH) issued a public health notification (PHN) updating data on mortality associated with Medtronic Vascular's (Santa Rosa, CA) AneuRx stent graft system. According to Dr. Schultz, this notification is made to re-emphasize the need for continued surveillance of patients treated with endovascular grafts and to provide physicians with updated information on the mortality risks associated with the use of the AneuRx device to prevent abdominal aortic aneurysm (AAA) rupture. Medtronic stated that this PHN is consistent with the company's 5-year clinical data update, which was distributed with the October 2007 issue of Endovascular Today.

Dr. Schultz stressed that this notification focuses on the AneuRx system because it is the only currently marketed device with a significant number of patients with clinical follow-up at 5 years. Medtronic noted that as one of the first commercially available AAA stent grafts approved in the US, the AneuRx system has the longest and largest dataset of patients treated with early stent graft devices. The other devices on the market are the Powerlink (Endologix, Inc., Irvine, CA), the Excluder (Gore & Associates, Flagstaff, AZ), and the Zenith (Cook Medical, Bloomington, IN). The CDRH's complete notification with recommendations is available online at www.fda.gov/cdrh.

According to Dr. Schultz, the CDRH's earlier notifications suggested an increasing trend in aneurysm-related mortality (ARM) among AneuRx graft patients. The CDRH had estimated that late ARM was approximately 0.4% per year. The CDRH now has additional, longer-term data that suggest that ARM continues to increase after 3 years from the implant, reaching 1.3% by year 4 and 1.5% by year 5. These rates are substantially higher than the mortality rate for open surgical repair, which averages 0.18% per year with a range of 0% to 0.3% per year, stated Dr. Schultz.

Medtronic responded that the CDRH's analysis focused on late ARM and did not cover the early benefits of endovascular aneurysm repair. The company noted that recent level-1 evidence from the UK EVAR-1 trial published in The Lancet showed the short-term benefits of endovascular repair (1.7%) versus open surgical repair (4.7%) are significant and are consistent with the AneuRx (2005;365:2179-2186). This benefit was sustained out to 4 years as demonstrated by the EVAR-1 trial results. The FDA analysis estimated an average 0.18% per year mortality rate for open surgical repair, which was based on a review of historical published literature. Based on the EVAR-1 trial, the average mortality rate for open repair was 0.58% per year. The cumulative long-term freedom from ARM of 96% from the EVAR-1 endovascular group compared favorably to the AneuRx freedom from ARM at 4 years of 96%. Additionally, the EVAR-1 surgical control group freedom from ARM was 93% at 4 years, the company stated.

According to the CDRH, clinicians should consider the information available in the product labels and in the yearly clinical updates from Medtronic and other graft manufacturers when selecting treatment options for patients with AAAs and in following previously treated patients.

The clinical updates for three of the currently marketed AAA endovascular grafts, the AneuRx, Powerlink, and Excluder, are available online at www.medtronic.com/physician/aneurx/experience, www.endologix.com/health_clinical.php, and www.goremedical.com/excluder/annualupdate.html. The Cook Zenith clinical update can be obtained by request at www.cookmedical.com/home.do.

Medtronic Launches Xcelerant Hydro Delivery System for Talent AAA Stent Graft in Europe
March 12, 2008—Medtronic Vascular (Santa Rosa, CA) announced the European market launch of the Talent abdominal stent graft on the new Xcelerant Hydro delivery system, which features a hydrophilic coating designed to aid navigation of the device through tight and tortuous arteries by reducing friction with the artery wall. The device is intended for the endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA).

The company noted that the Xcelerant Hydro delivery system was shown in bench testing to generate a 99% reduction in friction compared to the previous delivery system, which does not have the hydrophilic coating. The device features an integrated sheath that contributes to the system's low-profile characteristics, which are intended to enable excellent tracking and access through small vessels.

According to Medtronic, EVAR has been shown to be an effective therapy for AAAs, with fewer postoperative complications and shorter recovery times than open surgical repair. In The Lancet, Professor Roger M. Greenhalgh, MD, for the EVAR trial participants, published a UK study that the 30-day mortality rate for EVAR patients was 1.7% compared to 4.7% for patients who underwent open repair, a nearly threefold difference (2004;364:843-848). Similarly, the New England Journal of Medicine recently published results from a US study by Marc L. Schermerhorn, MD, et al indicating that perioperative mortality was significantly lower after EVAR than after open repair (1.2% vs 4.8%; a fourfold difference) (2008;358:464-474).

"The Xcelerant Hydro delivery system is a significant innovation that will make EVAR using the Talent stent graft a treatment option for more patients with abdominal aortic aneurysms," commented Dierk Scheinert, MD, PhD, the leader of the first team to implant the device using the new delivery system. "It will simplify the procedure for endovascular interventionists in treating patients whose iliac arteries are difficult to navigate when they are small and tortuous."

EVAR Safer Than Open AAA Repair
January 31, 2008—Marc L. Shermerhorn, MD, et al published a study in the New England Journal of Medicine that concluded that endovascular repair of abdominal aortic aneurysms (AAAs) is associated with lower short-term rates of death and complications compared with open repair (2008;358:464-474). The survival advantage is more durable among older patients. Late reinterventions related to AAA are more common after endovascular repair but are balanced by an increase in laparotomy-related reinterventions and hospitalizations after open surgery, the investigators found.

According to the investigators, randomized trials have shown reductions in perioperative mortality and morbidity rates with endovascular repair of AAAs, as compared with open surgical repair. Longer-term survival rates, however, were similar for the two procedures. There are currently no long-term, population-based data from the comparison of these strategies. Therefore, the investigators studied perioperative rates of death and complications, long-term survival, rupture, and reinterventions after open repair as compared with endovascular repair of AAAs in propensity score-matched cohorts of Medicare beneficiaries undergoing repair during the 2001-2004 period, with follow-up until 2005.

As detailed in the New England Journal of Medicine, there were 22,830 matched patients undergoing open repair of AAAs in each cohort. The average age of the patients was 76 years, and approximately 20% were women. The results showed that the perioperative mortality rate was lower after endovascular repair than after open repair (1.2% vs 4.8%; P<.001), and the reduction in mortality increased with age (2.1% difference for patients 67 to 69 years old vs 8.5% for those 85 years or older; P<.001). Late survival was similar in the two cohorts, although the survival curves did not converge until after 3 years. By 4 years, rupture was more likely in the endovascular-repair cohort than in the open-repair cohort (1.8% vs 0.5%; P<.001), as was reintervention related to AAA (9% vs 1.7%; P<.001), although most reinterventions were minor. In contrast, by 4 years, surgery for laparotomy-related complications was more likely among patients who had undergone open repair (9.7%, vs 4.1% among those who had undergone endovascular repair; P<.001), as was hospitalization without surgery for bowel obstruction or abdominal-wall hernia (14.2% vs 8.1%; P<.001).

Also in the New England Journal of Medicine, Professors Roger M. Greenhalgh, MD, and Janet T. Powell, MD, PhD, presented a case of an endovascular AAA repair that included a therapeutic recommendation, a discussion of the clinical problem, and the mechanism of benefit of this form of therapy (2008;358:494-501). Major clinical studies, the clinical use of this therapy, and potential adverse effects are reviewed. Relevant formal guidelines are presented, and clinical recommendations are suggested.

Cook's STARZ-TX2 1-Year TEVAR Data Published
January 28, 2008—In the Journal of Vascular Surgery, Jon S. Matsumura, MD, et al have published the 1-year results from the STARZ-TX2 trial of the Cook Medical's (Bloomington, IN) Zenith TX2 endovascular graft (2008;47:247-257). This trial evaluated the safety and effectiveness of thoracic endovascular aortic repair (TEVAR) with this contemporary endograft system compared with open surgical repair of descending thoracic aortic aneurysms and large ulcers.

In the study, 42 international trial sites enrolled 230 subjects with descending thoracic aortic aneurysms or ulcers. The study compared 160 TEVAR subjects treated with the Zenith TX2 with 70 open-repair subjects. Subjects were evaluated before the procedure, before discharge, at 1, 6, and 12 months, and annually for 5 years with medical examination, laboratory testing, chest radiographs, and CT scans. Mortality rates, prespecified severe morbidity composite index, major morbidity, clinical utility, aneurysm rupture, and secondary interventions were compared. The TEVAR subjects were evaluated by a core laboratory for device performance, including change in aneurysm size, endoleak, migration, and device integrity.

As detailed in the Journal of Vascular Surgery, the 30-day survival rate was noninferior (P<.01) for the TEVAR group compared with the open-repair group (98.1% vs 94.3%). The severe morbidity composite index was lower for TEVAR (0.2±0.7 vs 0.7±1.2; P<.01). Cumulative major morbidity scores were significantly lower at 30 days for the TEVAR group compared with the open-repair group (1.3±3 vs 2.9±3.6; P<.01). The TEVAR patients had fewer cardiovascular, pulmonary, and vascular adverse events, although neurologic events were not significantly different. Clinical utility for the TEVAR patients was superior to that of the open-repair patients. No ruptures or conversions occurred in the first year. Reintervention rates were similar in both groups. At 12 months, aneurysm growth was identified in 7.1% (8/112), endoleak in 3.9% (4/103), migration (>10 mm) in 2.8% (3/107), and other device issues were rare. None of the patients with migration experienced endoleak, aneurysm growth, or required a secondary intervention.

From these data, the investigators concluded that TEVAR with the TX2 is an effective and safer alternative to open surgical repair for treating anatomically suitable descending thoracic aortic aneurysms and ulcers at 1-year follow-up. Device performance issues are infrequent, but careful planning and regular follow-up with imaging remain a necessity.

On January 22, Cook Medical announced commencement of patient enrollment in the STABLE clinical trial to evaluate the Cook Zenith dissection endovascular system for treating type B thoracic aortic dissections. The system is composed of the new Cook Zenith dissection stent, used in conjunction with the Cook Zenith TX2 endovascular graft. The first patient found suitable for inclusion in the STABLE dissection clinical trial was a 60-year-old man diagnosed with a type B dissection of his thoracic aorta. He was treated with the Zenith dissection system. The TX2 stent graft repaired the primary entry tear. The bare-metal dissection stents were placed to expand and support the remainder of the dissected aorta for the length of the dissection, which, in this case, was to the level of the aortic bifurcation.

The Cook Zenith dissection endovascular system is intended for use in the endovascular treatment of descending thoracic aortic dissection in patients with anatomies appropriate for endovascular repair. The device's Z-stent exerts pressure that allows gradual apposition of the dissection septum and re-expansion of the true lumen, while not covering important arteries supplying the spinal cord with blood. The uncovered Zenith dissection stent is used to expand the true lumen in the distal thoracic aorta where preservation of the side branch artery blood flow is critical. In the US, the Cook Zenith dissection endovascular system is an investigational device not commercially available. The Cook Zenith TX2 endovascular graft is approved in Europe, Australia, and New Zealand for the treatment of thoracic aortic aneurysms and dissections.

Costs of Endovascular Coiling Compared to Surgical Clipping
January 1, 2008—In Stroke, Jane Wolstenholme, PhD, et al published a study in which investigators considered the treatment pathways, resource use, and costs of endovascular coiling versus surgical clipping after aneurysmal subarachnoid hemorrhage (2008;39:111-119). The investigators concluded that there is no significant difference in costs between the endovascular and neurosurgery groups at 12- or 24-month follow-up.

According to the investigators, the background of the study is the following: The International Subarachnoid Aneurysm Trial (ISAT) reported that endovascular coiling yields better clinical outcomes than surgical clipping at 1 year. The high cost of the consumables associated with the endovascular coiling procedure (particularly the coils) led health care purchasers to conclude that coiling was a more costly procedure overall. To examine this assumption and provide evidence for future policy, accurate and comprehensive data are required on the overall resource usage and cost of each strategy, the investigators stated.

In the study, the investigators provide detailed results of patient treatment pathways, resource utilization, and costs up to 24 months after randomization for endovascular and neurosurgical treatment of aneurysmal subarachnoid hemorrhage. Data are reported on costs related to initial and subsequent procedures (ward days, intensive care unit, equipment, staff, consumables, etc.), adverse events, complications, and follow-up. The data are based on a subsample of all patients randomized in ISAT, across 22 centers (n=1,644) in the UK. There was a nonsignificant difference of -£1,740 (-£3,582 to £32) in the total 12-month cost of treatment in favor of endovascular treatment. Endovascular patients had higher costs than neurosurgical patients for the initial procedure, for the number and length of stay of subsequent procedures, and for follow-up angiograms. However, these factors were more than offset by lower costs related to length of stay for the initial procedure. In the following 12- to 24-month period, costs for subsequent procedures, angiograms, complications, and adverse events were greater for the endovascular patients, reducing the difference in total per patient cost to -£1,228 (-£3,199 to £786) over the first 24 months of follow-up, reported the investigators.

Endovascular Treatment of TAAA Supported in JVS Study
January 2, 2008—A study by Timothy A.M. Chuter, MD, et al that assessed the role of multibranched stent grafts for thoracoabdominal aortic aneurysm (TAAA) repair was published in the Journal of Vascular Surgery (JVS). The investigators found that multibranched stent graft implantation eliminates aneurysm flow, preserves visceral perfusion, and avoids many of the physiologic stresses associated with other forms of repair. The results support an expanded role for this technique in the treatment of TAAA, the investigators concluded.

As detailed in JVS, the investigators used self-expanding covered stents to connect the caudally directed cuffs of an aortic stent graft with the visceral branches of a TAAA in 22 patients (16 men, 6 women) with a mean age of 76±7 years. All patients were unfit for open repair, and nine had undergone previous aortic surgery. Customized aortic stent grafts were inserted through surgically exposed femoral (n=16) or iliac (n=6) arteries. Covered stents were inserted through surgically exposed brachial arteries. Spinal catheters were used for cerebrospinal fluid pressure drainage in 22 patients and for spinal anesthesia in 11 patients. All 22 stent grafts and all 81 branches were deployed successfully. The results demonstrated that aortic coverage, as a percentage of subclavian-to-bifurcation distance, was 69%±20%. Mean contrast volume was 203 mL, mean blood loss was 714 mL, and mean hospital stay was 10.9 days. Two patients (9.1%) died perioperatively: one from guidewire injury to a renal arterial branch and the other from a medication error. Serious or potentially serious complications occurred in nine of 22 patients (41%). There was no paraplegia, renal failure, stroke, or myocardial infarction among the 20 surviving patients. Two patients (9.1%) underwent successful reintervention: one for localized intimal disruption and the other for aortic dissection, type I endoleak, and stenosis of the superior mesenteric artery. One patient had a type II endoleak. Follow-up was available for more than 1 month in 19 patients, more than 6 months in 12 patients, and more than 12 months in eight patients. One branch (renal artery) occluded for a 98.75% branch patency rate at 1 month. The other 80 branches remained patent. There were no signs of stent graft migration, component separation, or fracture, the investigators reported in JVS.

2007

Dynamic Cine-CT and MR Imaging Studied With EVAR
November 16, 2007—At the 34th Annual VEITH Symposium in New York City, Hence J.M. Verhagen, MD, presented findings from a study of the influence of the cardiac cycle on aortic configuration and diameter by using dynamic cine-CTA and MRA to observe the dynamics of acute dissections. The investigators also evaluated renal artery and aortic arch vessel movement. The investigators concluded that dynamic cine-CTA and MRA show insight into the dynamics of aortic disease and their endoluminal treatment that may improve the understanding of aortic pathology and be an important tool to improve stent graft design and treatment results.

According to Dr. Verhagen, CTA is the preferred modality for evaluation of aortic aneurysmal disease and dissections. Because CTA is used for endograft sizing and follow-up, it forms the basis of crucial endograft treatment decisions. The accuracy of measurements taken from CTA, however, is uncertain because they rely on static images of a dynamic process. The investigators' methods included pre- and postoperative measurements performed using electrocardiography-gated 64-slice CTA or dynamic MRA. Changes were measured in transverse aortic sections at different relevant levels. Center-of-mass displacement of the renal arteries and aortic arch vessels was determined per heartbeat. Data were analyzed using image segmentation software (DynamiX, Image Sciences Institute, Utrecht, The Netherlands). Differences were compared with p2 .05 significance.

Dr. Verhagen stated that the results of the dynamic cine-CTA and MRA demonstrated significant aortic diameter changes during the cardiac cycle both before and after endovascular aneurysm repair (EVAR) at all levels (mean 8.9%–11.5%; P<.001 for all levels). The investigators found that EVAR had no effect on changes in the aortic area and diameter. Cardiac-induced preoperative renal artery motion was up to 3 mm and was unchanged after either endograft treatment. Fenestrated EVAR with the placement of renal stents almost abolishes renal artery motion (.3 mm; SD, .1; range, .2–.5 mm; p2 .01). Dynamic imaging gave relevant insight in acute dissections and arch vessel movement and showed that the aorta is a truly dynamic environment, said Dr. Verhagen.

Medtronic Announces 5-Year Clinical Data for AneuRx
October 2, 2007—Medtronic CardioVascular, Endovascular Innovations (Santa Rosa, CA) announced the release of its fourth edition of the AneuRx Clinical Update, representing the largest collection of clinical data available for any commercially approved endograft. The update includes data on more than 1,000 patients in its clinical trial and 70,000 implants since 1996. The Clinical Update was distributed to more than 18,000 physicians worldwide as an insert in the September 2007 issue of Endovascular Today and is also on the AneuRx section of the company's Web site, www.medtronic.com.

According to the company, a principal component of the Clinical Update is newly released long-term data from the AneuRx IDE (investigational device exemption) clinical trial, which included 1,193 patients treated with an early generation of the AneuRx device. Of the more than 600 patients in the trial, 96% were free from an aneurysm-related death at 5 years of follow-up. In collaboration with the FDA, Medtronic also analyzed aneurysm-related death using a broader FDA definition, and the analysis showed a freedom from aneurysm-related death at 5 years of 94.6%. Between 4 and 5 years of follow-up, there was an observed increase in aneurysm-related death. Factors that were associated with late aneurysm-related death include, but are not limited to, poor follow-up, patients refusing treatment, and an elderly patient population. These data show the continued safety and efficacy of this device, taking into consideration early-generation endograft designs, the physician learning curve for implantation technique, and liberal patient selection criteria, the company stated.

In addition to the updated IDE clinical trial results, Medtronic also reported on the AneuRx Postmarket Surveillance Registry and the Lifeline Registry of Endovascular Aneurysm Repair, both of which provide contemporary, real-world usage data on the AneuRx stent graft. In the Postmarket Surveillance Registry, at 3 years, patients experienced freedom from aneurysm rupture of 99% and freedom from surgical conversion of 96%. The incidence of migration in both registries consisted of a single report of migration out of a 334-patient cohort, representing a migration rate of .3% at 3 years, according to Medtronic. Other key areas highlighted in the Clinical Update include information on endoleaks, migration, and the related critical importance of appropriate patient follow-up for successful long-term outcomes, the company stated.

Obesity Linked to Risk of AAA
October 29, 2007—A study by Jonathan Golledge, MD, et al investigated the association between anthropometric measures of obesity, serum adipokines, and abdominal aortic aneurysm (AAA), noting that obesity is associated with occlusive artery disease but is not considered a risk factor for AAA. The investigators concluded that measures of obesity are independently associated with AAA. Serum resistin concentrations were more strongly associated with aortic diameter than adipokines, which are more intimately associated with adiposity. Further studies are required to investigate the mechanisms linking resistin and AAA, the investigators stated. The study will be published in Circulation and is available online at circ.ahajournals.org.

As detailed in Circulation, the investigators screened 12,203 men 65 to 83 years of age for AAA using ultrasound, as part of a population study. Of those men, 875 had an AAA (≥30 mm). Cardiovascular risk factors and waist and hip circumference were recorded. Serum adipokines were measured in 952 men, 318 of whom had an AAA. Waist circumference (odds ratio [OR], 1.14; 95% confidence interval [CI], 1.06–1.22) and waist-to-hip ratio (OR, 1.22; 95% CI, 1.09–1.37) were independently associated with AAA after adjustment for other known risk factors. The association was stronger for AAA ≥40 mm (waist-to-hip ratio: OR, 1.53; 95% CI, 1.26–1.85). Serum resistin concentration was strongly independently associated with AAA (OR, 1.53; 95% CI, 1.32–1.76) and aortic diameter (β=.19, P<.0001). Serum adiponectin was associated with AAA ≥30 mm (OR, 1.26; 95% CI, 1.07–1.50) but not AAA ≥40 mm (OR, 1.03; 95% CI, .77–1.39). Serum leptin was not associated with AAA, the investigators reported in Circulation.

Endologix's Visiflex Used With Powerlink in AAA Treatment
October 3, 2007—Endologix, Inc. (Irvine, CA) announced the first procedures using the company's Powerlink system with its Visiflex Integrated System (IS) for the minimally invasive treatment of abdominal aortic aneurysms. The first seven procedures using the Visiflex IS were performed at Southern Clinic in Nuremberg, Germany; Imelda Hospital in Bonheiden, Belgium; St. Joseph Hospital in Marseille, France; and the Wilhelminenspital in Vienna, Austria. The Powerlink with Visiflex IS has received CE Mark approval for sale in the European Union, but it is not approved for sale in the US, the company advised.

According to the company, the Visiflex IS is the company's third-generation delivery system. It is designed to simplify endoluminal stent graft deployment and catheter withdrawal by eliminating the front sheath. The single-sheath design provides easier insertion through challenging iliac anatomy and allows interventionists to treat a broader spectrum of patients. The Visiflex IS uses the Powerlink's outer sleeve as a 19-F hemostatic introducer sheath to act as a conduit for adjunctive procedures and eliminates catheter exchanges, the company stated.

Abbott's ProGlide Shows Success in Percutaneous Access
May 30, 2007—The Society for Vascular Surgery announced that a study in the Journal for Vascular Surgery reports that totally percutaneous access for endovascular abdominal aorta repairs (EVAR) and thoracic endovascular aorta repairs (TEVAR) are safe and feasible using the Perclose ProGlide device (Abbott Vascular, Redwood City, CA) (2007;45:1095-1101). Investigators from the Division of Vascular Surgery and Endovascular Therapy at the University of Florida in Gainesville noted that the ProGlide with larger sheaths in a select group of patients showed a higher technical success rate (94.6%) than historically reported when using Abbott Vascular's Prostar XL device.

Between December 2004 and August 2006, 262 EVAR procedures were performed with percutaneous access. The technique involved deployment of two ProGlide devices before sheath insertion with the sutures left extracorporeally for closure after the procedure ("preclose technique"). A total of 559 ProGlide devices were used to close 279 femoral arteries. Of those, 175 femoral arteries required insertion of 18-F to 24-F sheaths (6.7-mm to 8.6-mm outer diameter). For EVAR and TEVAR procedures, the success rates when using 12-F to 16-F sheaths were higher than for the 18-F to 24-F sheaths (99% vs 91.4%). The preclose technique also resulted in shorter overall procedure times as compared to a similar cohort using open femoral exposures (EVAR, 115 vs 128; TEVAR, 80 vs 112).

LeMaitre Vascular to Begin UNITE Trial of UniFit AAA Stent
June 12, 2007—LeMaitre Vascular, Inc. (Burlington, MA) announced the enrollment of the first patient in the UNITE aorto-uni-iliac stent graft clinical trial, a pivotal study to evaluate the safety and effectiveness of the UniFit abdominal stent graft in the treatment of aorto, aorto-iliac, and iliac aneurysms. The endovascular procedure was conducted at Emory University in Atlanta, Georgia. The company announced on May 9 that the FDA granted an IDE supplement to conduct the trial.

According to the company, UNITE will enroll 90 patients in up to 14 centers who will be followed for at least 1 year before LeMaitre's premarket approval application to the FDA. The primary effectiveness endpoint of the study is based on aneurysm exclusion as evaluated through 1-year follow-up. The UNITE study compares the safety and efficacy of the UniFit against open-surgical abdominal aorta aneurysm repair, the company stated.

The UniFit, which is commercially available in the European Union, features a single-bodied, encapsulated design to prevent its stents from touching the vessel wall and allows a wider range of stent graft sizes. The company noted that the FDA's IDE approval applies only to the investigational use of UniFit stent grafts that have been sterilized with ethylene oxide gas. UniFit devices sold outside the US are sterilized with hydrogen peroxide, a newer and generally faster means of sterilizing medical devices that enables more rapid production of customized stent grafts, according to the company. LeMaitre Vascular stated that it is working with the FDA to resolve questions regarding this method of sterilization with the intent of seeking a premarket approval for UniFit systems processed in the manner.

Medtronic Talent's 12-Month VALOR Data Presented at SVS
June 8, 2007—Medtronic, Inc. (Minneapolis, MN) announced that Ronald M. Fairman, MD, Principal Investigator for the VALOR (Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms) clinical study, presented positive 12-month results for the study at the 61st Annual Meeting of the Society for Vascular Surgery in Baltimore, Maryland. VALOR is evaluating the company's Talent thoracic stent graft system in a prospective, multicenter study of 195 test group patients with thoracic aortic aneurysms who were considered candidates for open surgical repair. The primary endpoint is all-cause mortality at 12 months, comparing endovascular stent graft treatment to a historical surgical control group.

According to Medtronic, Dr. Fairman reported that patients in the test group who received the Talent thoracic stent graft had a statistically significant reduction in all-cause mortality (16.1% vs 29.8% in the control group; P<.001), using literature-derived figures for the open surgery group. Aneurysm-related mortality in the VALOR trial was 3.1% at 12 months. The Talent thoracic system also had a successful aneurysm treatment rate of 89.2%, defined as no aneurysm growth >5 mm between 1 and 12 months and the absence of a type 1 endoleak. The Talent system demonstrated 100% patency with a 99.5% deployment success rate. The Talent features a wide range of sizes, with 22-mm to 46-mm diameters, allowing the therapy to be available to a greater number of patients. In March 2007, Medtronic submitted a premarket approval application to the FDA based on the VALOR data and is awaiting approval. The Talent has been available outside the US since 1998.

In other company news, Medtronic reported that Rudy Boesch, the oldest participant in the reality television series Survivor, has survived another challenge. The former US Navy Seal, who at age 79 competed with people half his age for 6 weeks on the island of Borneo, was diagnosed with an abdominal aortic aneurysm (AAA). The AAA was detected in an x-ray of Mr. Boesch's back, which he injured while weightlifting. He went to vascular surgeon Richard DeMasi, MD, for an endovascular implantation of a Medtronic AneuRx AAA stent graft. Mr. Boesch resumed exercising in 6 weeks and has completely recovered. He and his wife will compete in the racquetball event in the 2007 Summer National Senior Olympic Games. Medtronic, a charter member of the National Aneurysm Alliance, is highlighting Mr. Boesch's experience to increase public awareness of the importance of AAA screening. Since 2004, the National Aneurysm Alliance has provided more than 31,000 screenings, in which approximately 600 AAAs have been detected.

Data for Cook's STARZ-TX2 TEVAR Study Presented at SVS
June 9, 2007—Jon S. Matsumura, MD, et al presented early results of STARZ-TX2, a clinical trial to evaluate thoracic endovascular aortic repair (TEVAR) in the elective treatment of patients with descending thoracic aortic aneurysms or ulcers. The presentation was made at the 61st Annual Meeting of the Society for Vascular Surgery in Baltimore, Maryland. STARZ-TX2 is an international, nonrandomized, controlled trial comparing the safety and effectiveness of open-surgical repair (control) with TEVAR using the Zenith TX2 TAA (thoracic aortic aneurysm) endovascular graft (Cook Medical, Bloomington, IN). The Zenith TX2 features a modular system of tubular components constructed of self-expanding, stainless steel Z-stents sewn to full-thickness woven polyester fabric. In the trial, 160 TEVAR patients and 70 control patients were enrolled at 42 medical centers between March 2004 and July 2006.

According to the investigators, 72% of TEVAR subjects and 60% of controls were male. Mean age was 72 years for the TEVAR group and 68 years for the control group. Two patients in the TEVAR group did not receive the device due to access concerns. Clinical utility measures were markedly superior in the TEVAR group compared to the control group (ie, intraoperative red blood cell transfusion [TEVAR 3%, control 87%] and days to hospital discharge [TEVAR 5±9 days, control 16±19 days]). After 30 days, perioperative mortality was lower in the TEVAR group compared to the control group (1.9% vs 5.7%), and sentinel perioperative major morbidity events were lower in the TEVAR group compared to controls: stroke (2.5% vs 7.1%), paraplegia (1.3% vs 5.7%), and renal failure requiring dialysis (1.3% vs 4.3%). Through 30 days, secondary interventions were performed on three TEVAR patients and three control patients. There were no aneurysm ruptures in either group, and there were no conversions to open repair in the TEVAR group. Also, preliminary 1-year data presented at the meeting included a 1-year survival rate of 92% in the TEVAR cohort.

The STARZ-TX2 investigators concluded that preliminary 30-day results of this trial suggest that TEVAR has mortality, major morbidity, and clinical utility that compare favorably to open repair, with no ruptures in either group, and no conversions in the TEVAR group, the investigators stated. Analysis of the 12 month data is almost completed and will be submitted for peer review, the investigators stated.

TEVAR With Gore TAG Studied in Complex Pathology
June 7, 2007—At the 61st Annual Meeting of Society for Vascular Surgery (SVS) in Baltimore, Maryland, Richard P. Cambria, MD, et al, presented data from a prospective study designed to evaluate the use of the Gore TAG (Gore & Associates, Flagstaff, AZ) thoracic endoprosthesis for the thoracic endovascular aneurysm repair (TEVAR) of thoracic aortic rupture (TAR), acute complicated type B dissections (AD), and traumatic aortic tear (TAT) at 14 academic medical centers. The investigators concluded that the preliminary data suggest the utility of TEVAR for life-threatening complex thoracic aortic pathology wherein conventional surgical treatment has traditionally been accompanied by excess mortality and/or paraplegia. Further analysis is underway.

From August 2005 to February 2007, the trial enrolled 59 patients (20 TAR/19 AD/20 TAT). Thirty-day outcomes were available. The investigators reported that demographic/clinical data included that 80% of patients were male, with median age of 66 years, but differed widely as function of pathology (80 years for TAR but 53 years for AD/TAT). Mean injury stroke scale (ISS) in TAT patients was 36, and mean SVS risk score was highest (7.6±5.6) in TAR patients. There were no arterial access or deployment failures. Thirty-day composite death/paraplegia occurred in eight of 59 (13.6%) patients with a single paraplegia event (1.7% overall) in a TAT patient; six (10.2%) patients experienced reversible paraparesis. Of the six patients, three died without known recovery from paraparesis, two recovered, and one was ongoing, although this patient had no motor function assessment before treatment.

Thirty-day mortality was 5% for TAT, but in the 15% range for both TAR/AD. American Society of Anesthesiologists class was the sole independent predictor of mortality/paraplegia (odds ratio, 4; 95% confidence interval, 1.3-18). Procedural deployment-related adverse events occurred in seven (11.9%) patients and included two instances of extension of AD. Device-related adverse events through 30-day follow-up occurred in eleven (18.6%) patients: rupture in two AD patients, graft infection (presented with infection, but not confirmed until after treatment) in one TAR patient, graft collapse in two TAT patients and major endoleak in six patients; three (5% overall) of these underwent explant/open conversion. Four reinterventions with TEVAR were performed: three for endoleak and one for persistent aortic dissection, the investigators reported.

Cordis Neurovascular's Enterprise Granted HDE to Treat Intracranial Aneurysms
May 10, 2007—Cordis Neurovascular, Inc., (a division of Cordis Corporation, a Johnson & Johnson company, Miami, FL) announced that the FDA has granted Humanitarian Device Exemption (HDE) approval for the Cordis Enterprise vascular reconstruction device and delivery system for use with embolic coils in the treatment of wide-neck intracranial aneurysms. The Enterprise is a self-expanding nitinol stent with a closed-cell design. It is available in the US for use in patients with hard-to-treat aneurysms selected for endovascular neurointervention. Specifically, the stent is approved to treat wide-neck, intracranial, saccular, or fusiform aneurysms arising from a parent vessel with a diameter ≥3 mm and ≤4 mm. The clinical outcomes from the Cordis Enterprise Vascular Reconstruction Device Study, which enrolled patients in Europe and the US, were assessed by an independent core lab. Data from the independently evaluated clinical study suggest that the Enterprise is a promising assist device for the treatment of aneurysms, but the device's effectiveness for this use has not been demonstrated, the company noted.

ev3's Onyx HD 500 Liquid Embolic System Receives HDE to Treat Cerebral Aneurysms
April 16, 2007—ev3 Inc. (Plymouth, MN) announces that it has received an FDA Humanitarian Device Exemption (HDE) approval for the Onyx HD 500 liquid embolic system for the treatment of intracranial aneurysms. The HDE allows ev3 to market the Onyx for use in patients with wide-necked cerebral aneurysms. The HDE is limited to saccular, sidewall aneurysms with dome-to-neck ratios of <2 mm that are not amenable to treatment with surgical clipping. In July 2005, the Onyx 18 and 24 systems received FDA approval for the treatment of cerebral arteriovenous malformations.

According to the company, marketing of the Onyx HD 500 will be preceded by a lengthy period of education and training of a small group of leading neurovascular specialists. Once trained, this group of proctors will help ensure that the use of Onyx HD 500 is carefully controlled as is required for all HDE-approved devices. A US Investigational Device Exemption study and two European clinical studies examined approximately 200 patients with wide-necked aneurysms who were effectively treated with the Onyx HD 500. Wide-necked aneurysms occur in approximately 20% of the 17,000 patients who are treated with embolic coils each year in the US, the company stated.

MicroVention's HELPS Trial Completes Enrollment
April 5, 2007—MicroVention, Inc. (Aliso Viejo, CA) announced today the completion of enrollment in an independent, physician-designed and -managed, international trial of the company's HydroCoil embolization system for treating cerebral aneurysms.

According to the company, HELPS (HydroCoil Endovascular Aneurysm Occlusion and Packing Study) is a head-to-head prospective, blinded, randomized trial that compares the results of the HydroCoil system to results from approved bare-platinum coils. The trial is managed by the Lothian Health Board with initial support from the UK's National Health Service. The trial enrolled 500 patients at 24 medical centers from Scotland, England, Wales, Germany, France, Australia, Brazil, Northern Ireland, Argentina, and the US. The study's Chief Investigator is Philip White, MD, of Western General Hospital in Edinburgh, Scotland. Dr. White will present unblinded safety data and initial angiographic procedural data at the World Federation of Interventional and Therapeutic Neuroradiology meeting in Beijing in September 2007. The HydroCoil embolic system combines platinum microcoil technology with the company's Intelligel polymer, an expandable microporous hydrogel. MicroVention, which merged with Terumo Corporation (Somerset, NJ) in 2006, has received 510(k) clearance and CE Mark approval for the HydroCoil.

Boston Scientific Commences MAPS Brain Aneurysm Trial
April 2, 2007—Boston Scientific Corporation (Natick, MA) announced the commencement of enrollment in the company's MAPS (Matrix And Platinum Science) clinical trial. The MAPS trial is designed to identify and investigate clinically relevant endpoints for evaluating the efficacy and durability of endovascular treatment of brain aneurysms. Patients will be randomized to receive either Matrix2 detachable coils or GDC detachable coils. Boston Scientific manufactures both the GDC coils, which are bare-platinum detachable coils that are cleared for aneurysm treatment and the Matrix2 coils, which are covered with a polyglycolic-polylactic acid biopolymer shown to improve treatment durability in preclinical studies, the company stated.

According to the company, MAPS is a prospective, multicenter study that will randomize approximately 630 patients at 50 global centers for treatment of brain aneurysms. The trial's primary endpoint is target aneurysm recurrence, a composite of target aneurysm reintervention, target aneurysm rupture or rerupture, or death. The first patient was enrolled and treated by Michael Madison, MD, and James Goddard, MD, at the Healtheast Neurovascular Institute of St. Joseph's Hospital in St. Paul, Minnesota.

"Not only is this trial important in its own right, but it further demonstrates that multidisciplinary aneurysm trials can and will help define the future of aneurysm treatment," commented MAPS Co-Principal Investigator Cameron McDougall, MD, Chief of Endovascular Neurosurgery, at the Barrow Neurological Institute in Phoenix, Arizona.

Data Presented on Endologix Powerlink in Difficult AAAs
February 12, 2007—Endologix, Inc. (Irvine, CA) announced that favorable data presented at the International Congress XX on Endovascular Interventions (ICEI) supports the use of the company's Powerlink system in patients with anatomies considered difficult to treat with traditional endoluminal stent grafts (ELGs). The data include 5-year patient follow-up data from the Powerlink system pivotal clinical trial.

The Powerlink was featured in three presentations at ICEI, which was held February 9-15, 2007 in Scottsdale, Arizona. According to the company, "Secondary Intervention in Unfavorable AAA Neck Anatomy," an abstract presented by John T. Collins, MD, included core lab-reviewed data demonstrating the Powerlink's ability to effectively treat patients with reverse-tapered neck anatomies. Of the 50 patients in the Powerlink pivotal clinical trial identified with reverse-tapered aortic necks, no secondary procedures were required for migration or proximal type 1 endoleaks through a mean follow-up of 40.2 months (range, 1 to 64 months).

A second presentation, "New Approach to Prevent Distal Migration and Rupture in EVAR: Anatomical Fixation," by Dieter Raithel, MD, highlighted data from 378 patients treated during 7 years with the Powerlink. The data demonstrate the long-term efficacy of an implant strategy of anatomical fixation to place the Powerlink stent graft on the aortic bifurcation, which allows for treating anatomies previously unsuitable for endovascular aneurysm repair (EVAR).

The third presentation, "Results of EVAR for Small vs Large Aneurysms," by Jeffrey Carpenter, MD, discussed 5-year follow-up data from the pivotal study that indicate that patients with larger aneurysms treated with the Powerlink system had no greater incidence of major adverse events, secondary procedures, or endoleaks than those with smaller aneurysms. Dr. Carpenter noted that there were no aneurysm ruptures, no graft material failures, and no stent fractures through the 5-year follow-up period. These results demonstrated the device's durability, the company stated.

APEX Study of CardioMEMS EndoSure Published in JVS
January 29, 2007—Takao Ohki, MD, PhD, et al have published the initial results from the APEX trial (Acute Pressure Measurement to Confirm Aneurysm Sac EXclusion) trial in the Journal of Vascular Surgery (2007;2:227-235). The results were first presented at the 59th annual meeting of the Society for Vascular Surgery held in Chicago on June 16-19, 2005.

APEX is a prospective, multicenter, international trial sponsored by CardioMEMS, Inc. (Atlanta, GA), to evaluate the safety and efficacy of the company's EndoSure wireless pressure sensor for endovascular repair (EVAR). The EndoSure has been developed and tested in a clinical setting to increase its efficacy and safety for intraoperative endoleak detection. The investigators concluded that implantation of the wireless pressure sensor is safe, and remote aneurysm sac pressure sensing is feasible. It was a valuable guide in evaluating the completeness of the EVAR procedure. Long-term study will be needed to prove its efficacy for postoperative surveillance, the investigators stated.

According to the investigators, complete exclusion and depressurization of the aneurysm sac is the prime goal of EVAR of abdominal aortic aneurysms. Thus, any EVAR that results in a type 1 or 3 endoleak has been classified as a technical failure. The current method to detect endoleaks uses intraoperative aortography, which is limited by its subjective nature, inability to quantify the significance of the endoleak, and artifacts such as bowel gas that may mimic an endoleak. In addition, repetitive contrast injection may impair renal function, the investigators stated.

As detailed in the Journal of Vascular Surgery, the 30-mm X 5-mm X 1.5-mm sensor contains no battery and is powered externally with radiofrequency energy. The sensors are extremely stable, operate over the full physiologic range of pressures, and have a resolution of 1 mm Hg. Ninety patients, 76 of whom were eligible for analysis, were enrolled at 12 sites. The sensor was implanted via the contralateral femoral artery at the time of EVAR. The sac pulse pressure was measured with both an angiographic catheter and the sensor after deployment of the main endograft but before the deployment of the contralateral limb (type 1 endoleak equivalent). Sac pressure was again measured with the sensor after deployment of the contralateral limb and completion of the EVAR. Data were collected in a prospective manner. The investigators found that in all of the eligible patients (n=76), the initial sensor pressure measurement agreed closely with the angiographic catheter pressure measurement of the type 1 endoleak equivalent. At the completion of the procedure, there was agreement between the sensor measurement and angiography regarding the presence or absence of a type 1 or 3 endoleak in 92.1% (n=70) of the measurements. The sensitivity was 94%, and the specificity was 80% for detecting type 1 or 3 endoleaks. Final pulse pressures decreased significantly compared with baseline measurements.

"This trial demonstrates that this wireless sensor for aneurysm sac measurement is safe and feasible, and can be used to diagnose the location and type of endoleak during endovascular aneurysm repair," commented Dr. Ohki. Dr. Ohki noted that the APEX data were instrumental in the FDA approval of the EndoSure device, which is now commercially available for stent graft implantation procedures. Future studies will focus on using sac pressure monitoring as an alternative to computed tomography for long-term aneurysm surveillance.

Excellent Results Shown for EVAR of High-Risk AAAs
January 29, 2007—In the Journal of Vascular Surgery, Ruth L. Bush, MD, MPH, et al published a study of veterans who were deemed high risk for surgical therapy for the treatment abdominal aortic aneurysms (AAAs) (2007;2:227-235). The study found that outcomes after elective endovascular repair (EVAR) of AAAs are excellent and that the procedure is relatively safe in this special patient population. The retrospective data demonstrated that patients with considerable medical comorbidities and infrarenal AAAs benefit from and should be considered for primary EVAR.

According to the investigators, recent results after AAA EVAR have raised questions of its value in patients deemed at high risk for surgical intervention. The National Surgical Quality Improvement Program (NSQIP) of the Department of Veteran Affairs (VA) is the largest prospectively collected and validated US surgical database representing current clinical practice. The study's purpose was to evaluate outcomes after elective EVAR performed in high-risk veterans. Using NSQIP data from 123 participating VA hospitals, the investigators retrospectively evaluated patients who underwent elective aneurysm repair from May 2001 to December 2004. High-risk criteria were used to identify a cohort for analysis (EVAR, n=788; open, n=1580). High-risk criteria analyzed included age ≥60 years, American Society of Anesthesiology (ASA) classification 3 or 4, and the comorbidity variables of history of cardiac, respiratory, or hepatic disease, cardiac revascularization, renal insufficiency, and low serum albumin level. The primary end points were 30-day and 1-year all-cause mortality, and a secondary end point of perioperative complications was evaluated. Statistical analysis included univariate analysis and multivariate modeling.

As detailed in the Journal of Vascular Surgery, veterans who were classified as high risk underwent elective EVAR with significantly lower 30-day (3.4% vs 5.2%, P=.047) and 1-year all-cause mortality (9.5% vs 12.4%, P=.038) than patients having open repair. EVAR was associated with a decrease in 30-day postoperative mortality (adjusted odds ratio [OR], 0.65; 95% confidence interval [CI], 0.42 to 1.03; P=.067) as well as 1-year mortality (adjusted OR, 0.68; 95% CI, 0.51 to 0.91; P=.0094) despite the presence of severe comorbid conditions. The risk of perioperative complications was significantly lower after EVAR (16.2% vs 31%; P<.0001; adjusted OR, 0.41; 95% CI, 0.33 to 0.52; P<.0001). A subset analysis of higher-risk patients (ASA 4 and the above comorbidity variables) still demonstrated an acceptable 30-day mortality rate, the investigators reported.

Japan Grants Preliminary Reimbursement for AAA EVAR
January 18, 2007—Cook Medical (Bloomington, IN) announced that preliminary hospital reimbursement for endovascular repair of abdominal aortic aneurysms (AAAs) has been granted in Japan, where the company's Zenith AAA stent graft is approved for sale. Cook expects full reimbursement in March 2007, which will precipitate a complete rollout of the Zenith stent graft system in the country with its Japanese distributor, Medico's Hirata Co. Ltd. (Osaka, Japan). Hirata's approval was granted on July 11, 2006, under the Japanese Pharmaceutical Affairs Law. The Zenith endograft will be re-examined 3 years after the approval date. A requirement of approval includes providing detailed clinical training to Japanese physicians to ensure their safe and effective use of the device. The device has a 9-year history of successful use in Europe and a 7-year history in the US, Cook stated.

Gore Excluder Approved in Japan for AAA Treatment
January 30, 2007—Gore & Associates (Flagstaff, AZ) announced that the Japanese Pharmaceuticals and Medical Device Agency granted Shonin regulatory clearance for the company to market the Gore Excluder abdominal aortic aneurysm (AAA) endoprosthesis in Japan. The Gore Excluder is indicated for the endovascular treatment of AAAs. Gore also stated that it recently launched a new patient education resource intended to help provide the public with information about the causes, symptoms, and available treatments for AAAs. The resource, part of broader content and feature improvements to www.goremedical.com, guides visitors through a television-like experience that addresses questions and concerns commonly raised by those affected by AAAs.

2006

VALOR II and VIRTUE Study Medtronic's Valiant Stent Graft; Talent's VALOR Data Presented
December 15, 2006–Medtronic Vascular (Santa Rosa, CA) announced the first patient enrollments of two separate clinical trials, VALOR II and VIRTUE, as well preliminary results from the VALOR trial.

Joseph Bavaria, MD, of the University of Pennsylvania, enrolled the first patient in the VALOR II clinical trial, which will examine the safety and efficacy of Medtronic's Valiant stent graft in treating descending thoracic aortic aneurysms. The trial will enroll a maximum of 125 patients at up to 30 investigational sites in the US. The company anticipates that the data from VALOR II will be used to support a product approval application to the FDA. The national principal investigator for VALOR II is Ronald Fairman, MD, of the University of Pennsylvania.

Ivan Degrieck, MD, of the Onze-Lieve-Vrouw Hospital in Aalst, Belgium, enrolled the first patient in the VIRTUE registry. VIRTUE will enroll 100 patients at approximately 20 clinical centers in Western Europe to evaluate the use of the Valiant graft for the treatment of descending thoracic aortic dissections, known as type B dissections. According to the company, the objective of the VIRTUE registry is to collect additional data on the health economics and the clinical performance of Valiant for the treatment of acute dissections, complicated or expanding subacute dissections, and expanding chronic dissections. The VIRTUE registry's Principal Investigator is Prof. Matt Thompson, MD, of St. George's Hospital at the University of London. The Valiant stent graft has been available outside the US since 2005 for the treatment of thoracic aortic aneurysm, dissections, and other lesions.

On November 16, 2006, at a satellite event at the VEITH Symposium in New York City, Dr. Fairman presented 12-month safety endpoint data from the VALOR trial's test arm. The results met the primary safety endpoint for the trial. Based on the data, Medtronic Vascular would be filing for FDA approval of the Talent thoracic stent graft, stated Dr. Fairman.

The VALOR trial is a prospective, nonrandomized, multicenter, consecutive trial enrolling subjects into three study arms (test, registry, and high-risk). The objective of the test arm was to evaluate the safety and efficacy of the Talent thoracic stent graft system for patients with thoracic aortic aneurysm who are considered candidates for open surgical repair and are low-to-moderate risk, per modified SVS/AAVS criteria (categories 0, 1, or 2).

The primary safety endpoint of the VALOR test arm was all-cause mortality at 12 months (hypothesis: superiority of the VALOR test arm to a literature control of 30%); the primary efficacy endpoint was successful aneurysm treatment at the 12-month follow-up visit. Of the 195 patients entered into the test arm, 59% were male, and the mean age was 70.2 years. Most were considered SVS risk class 2 (72.8%), with 21% considered class 1. At 12 months, the all-cause mortality rate before the 12-month visit was 16.1% (31/193), with a confidence interval of 11.2% to 22%, Dr. Fairman reported.

Cook's Z-Trak Introduction System Receives CE Mark
December 4, 2006–Cook Medical (Bloomington, IN) announced CE Mark approval for the Z-Trak introduction system for its Zenith TX2 thoracic aortic aneurysm (TAA) endovascular stent graft. According to the company, by utilizing a hydrophilic-coated Cook Flexor sheath and superelastic alloy inner cannula, the Z-Trak Plus system is designed to provide enhanced precision and flexibility of entry and tracking well into the aortic arch. The Flexor sheath features kink-resistant tubing technology for superior flexibility, and a low coefficient of friction during use. Combining the Cook Flexor's capabilities with the Z-Trak delivery system allows the interventionist to navigate the aortic arch more easily to deliver the stent graft to the precise treatment location. The device's trackability and maneuverability provide precise, controllable device orientation and deployment of the Cook TAA stent graft, the company stated.

Cook's Zenith TX2 TAA endovascular graft is indicated for treatment of descending thoracic aortic aneurysm and type B aortic dissection. The TX2 is reinforced with self-expanding stainless steel Z-stents. It features circumferentially anchoring barbs on both the proximal and distal segments of the device, which provides superior fixation. Radial force from the self-expanding Z-stents allows the graft to provide an excellent seal within the patient's aorta. The Zenith TX2's US trial results will be submitted soon to the FDA for US market approval, the company stated.

"Packaging such a stent into a low-profile delivery system, which can negotiate the potential tortuosity of the iliacs, infrarenal aorta, and distal thoracic aorta and yet retain accurate deployment characteristics is vital when there is no room for error," commented Michael P. Jenkins, MD, of St. Mary's Hospital, London, UK. "I believe the Cook TX2 has made significant advances towards these goals."

Lombard's Refix Endostapler Earns CE Mark Approval
November 10, 2006–Lombard Medical Technologies PLC (Boston, MA) announced that it has received CE Mark approval for the Refix Endostapler. According to the company, the Refix has been initially designed to provide increased fixation of endovascular stent grafts to treat abdominal and thoracic aortic aneurysm. The device percutaneously delivers tiny fasteners (staples), which are pushed through both the wall of the stent graft and the wall of the aorta, to keep the stent graft firmly in place and prevent it from migrating, thus reducing the risk of endoleaks. In the US, Lombard Medical is seeking an IDE for Refix with an investigational study targeted to begin in early 2007, subject to FDA consent, the company stated.

Endologix's Powerlink 5-Year Follow-Up Data Presented
October 23, 2006–Endologix, Inc. (Irvine, CA) announced that Rodney A. White, MD, presented 5-year follow-up data on the Powerlink System pivotal clinical trial for the treatment of abdominal aortic aneurysm (AAA) at the 18th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, DC. According to the company, the data demonstrated that 97.9% of patients were free from AAA mortality; there were no aneurysm ruptures; there were no stent or graft material failures; and 86.6% of patients were free from device-related secondary procedures.

"The clinical data for the Powerlink System is compelling," commented Dr. White. "Endologix has set the bar as it pertains to the durability of the pivotal trial data set, with a 95% compliance of eligible patient follow-up at 5 years as well as core lab 3-D modeling."

Endologix Launches Visiflex Delivery System for AAA Treatment
October 2, 2006–Endologix Inc. (Irvine, CA) announced the US launch of its next-generation Visiflex delivery system for the deployment of the Powerlink endoluminal stent graft in the endovascular treatment of abdominal aortic aneurysms. The Visiflex received FDA approval in May 2006, and a limited strategic release was initiated for physician preference testing prior to the full launch this fall. According to the company, the Visiflex's new design improves delivery of the system by facilitating smoother insertion and withdrawal of the delivery catheter. The device also improves visibility under fluoroscopy while deploying the stent graft.

First US Procedure Performed With Aptus AAA System
July 24, 2006–Georgetown University Hospital announced that David H. Deaton, MD, Chief of Endovascular Surgery, performed the first procedure in the US using the Aptus AAA Repair System (Aptus Endosystems, Inc., Sunnyvale, CA). The Aptus system is an endovascular graft for the repair of an abdominal aortic aneurysm (AAA). The patient is the first to be enrolled in the FDA-sanctioned clinical trial designed to demonstrate the safety and efficacy of the repair system. As many as 25 patients will be slated for enrollment in the initial phase of the clinical trial, which is to be conducted in four US medical institutions. Dr. Deaton and Takao Ohki, MD, PhD, of Jikei University School of Medicine in Tokyo, were part of a team of specialists who worked during the last 2 years on the device's design and performed the first human implants of the device last summer in Venezuela. Both of those patients had successful outcomes and continue to do well, the hospital noted. Georgetown and its team of vascular surgeons were chosen as the site for the initial US procedure as a result of their involvement in the development of the device in cases done outside the US and during the preclinical phase, the hospital stated.

The current patient is a 69-year-old man who lost both of his parents to AAAs, so he was keenly aware of the danger represented by AAAs. He immediately sought vascular consultation at Georgetown when his primary care physician detected his aneurysm after an ultrasound test. The procedure occurred Wednesday morning, July 19, and the patient went home Thursday afternoon.

According to Aptus Endosystems, the AAA repair system consists of a highly conformable endograft, which is deployed from a low-profile delivery catheter and a unique endovascular stapler for securely attaching the endograft to the artery wall. The use of endovascular staples is designed to replace the need for barbs and/or transrenal stents, while enabling the treatment of short and angulated proximal necks. Georgetown noted that the Aptus endograft is the first endovascular device to be attached to the aortic tissue with individual staples that reproduce the suture fixation used in open surgical repair of AAAs. The capability to deliver the staples separately, and in locations determined by the surgeon, allows for a much smaller delivery device and secures the graft in place in a manner essentially identical to the grafts used in open surgical repair that has proven long-term results.

"The innovations of the Aptus endograft represent a potential revolution in the applicability and durability of endovascular aneurysm repair," commented Dr. Deaton. "This is the first endovascular technology that allows us to repair the aorta using the principles which are the foundation of the very successful open surgical repair that has been the standard over the last 50 years."

Cook's Zenith AAA Endograft Is First EVAR Device Approved in Japan
August 7, 2006—Cook Incorporated (Bloomington, IN) announced that the Zenith Endograft device for the endovascular repair of abdominal aortic aneurysms (AAAs) has been granted Shonin regulatory approval by the Japanese Ministry of Health, Labor, and Welfare. Cook noted that the Zenith endovascular graft system is the first and only device available for endovascular repair of AAAs in Japan. The device will be distributed in Japan by Medico's Hirata, Inc.

According to Cook, the Shonin filing was approved on July 11. The Zenith endograft is approved as a new medical device and that status will be re-examined 3 years after the approval date. Shonin was granted on the basis of the Zenith US pivotal trial results, and on the basis of the limited confirmation trial that was performed in Japan. The device has been successfully used in the US for 7 years and for 9 years in Europe, the company stated.

On July 13, Professor Takao Ohki, MD, PhD, of Jikei University School of Medicine in Tokyo, performed the first post-Shonin Zenith placement. Dr. Ohki, the newly appointed Chief of Vascular Surgery, had joined Jikei the previous week. According to Dr. Ohki, the first patient was a 62-year-old man who had been waiting for an endograft to become available for more than a year. The OR time (skin to skin) was 80 minutes and was performed under local anesthesia. The AAA was successfully treated with the Zenith endograft and the patient was discharged to home on the second day. Dr. Ohki related that after the procedure the patient said, "The procedure was painless and was worth the wait."

Dr. Ohki added, "The first approval of an endograft marks the beginning of a new era in endovascular therapy in Japan." He said that Shonin of the Gore Excluder (Gore & Associates, Flagstaff, AZ) and the Endologix PowerLink (Endologix Inc., Irvine, CA) is expected in late 2006.

Enrollment Completed in Cook's STARZ-TX2 TAA Trial
July 31, 2006—Cook Incorporated (Bloomington, IN) announced that patient enrollment has been completed in the STARZ-TX2 clinical trial (Study of Thoracic Aortic Aneurysm [TAA] Repair with the Zenith TX2 Thoracic TAA Endovascular Graft). The trial studied the safety and efficacy of Cook's Zenith TX2 for the treatment of TAAs by comparing the performance of the device in treatment of aneurysms in the descending thoracic aorta to traditional open surgery. The trial is assessing device performance, as well as patient survival and rupture rates over a 12-month period. The trial date is being prepared for submission to the FDA later this year for device approval, stated the company.

The trial enrolled more than 200 patients at 39 clinical sites around the world. All patients enrolled in the STARZ-TX2 trial are being evaluated at regular intervals during the 12 months after either insertion of the Zenith TX2 or open surgery. Patient data will continue to be monitored regularly. Cook said that while it has now enrolled enough patients to fulfill the study criteria, 11 clinical trial sites in North America are still providing TAA treatment with the Zenith device to patients through continued access. While designated as an investigational device and not commercially available in the US, the Zenith TX2 has been approved for sale in Europe, Australia, Brazil, Thailand, Singapore, Argentina, Peru, Mexico, Columbia, and New Zealand, the company noted.

FDA Approves Study of Abbott Vascular's Xpert Stent for Placement Below the Knee
May 31, 2006—VIVA Physicians, Inc. (VPI, San Jose, CA) and Abbott Vascular, Inc. (a division of Abbott Laboratories, Redwood City, CA) announced that the FDA has cleared the first US, multicenter, prospective clinical trial to investigate the use of minimally invasive stent placement to treat severe peripheral arterial disease (PAD) below the knee. The study, titled XCELL, is sponsored by VPI and supported by a restricted educational grant from Abbott Laboratories. The FDA has approved an investigational device exemption (IDE) for the study for the use of Abbott's Xpert expandable nitinol stent below the knee. VPI submitted its IDE application to study the stent's use in the popliteal and tibial arteries to the FDA on February 7. The Xpert is currently cleared in the US to treat blockages in the biliary ducts.

According to James Joye, DO, Principal Investigator for the XCELL trial, the study is one of only a very few independent, physician-sponsored efforts. VPI set the protocol, applied for the IDE, and is responsible for data collection, evaluation, and reporting. The study is expected to enroll 140 patients at 10 centers. The primary endpoint of the study is avoidance of major amputation at 12-months follow-up after treatment, Dr. Joye said.

"The Xpert stent is particularly appropriate for this trial because it is the only self-expanding stent that comes in a variety of sizes small enough to treat the blood vessels below the knee," commented Dr. Joye, whose center, El Camino Hospital in Mountain View, California, will be a participating site in the study.

Role of Cytokines in AAAs Demonstrated in Study
May 1, 2006—Koici Shimizu, MD, et al from The Donald W. Reynolds Cardiovascular Clinical Research Center at Harvard Medical School published "Inflammation and Cellular Immune Responses in Abdominal Aortic Aneurysms (AAAs)," which considered the role of Th1/Th2 cytokines in vascular disease. The article appeared as part of a series of brief reviews in Arteriosclerosis, Thrombosis, and Vascular Biology (2006;26:987-994) titled "Abdominal Aortic Aneurysms: Pathophysiological Mechanisms and Clinical Implications."

The investigators began with the observation that expansion and rupture of AAAs result in high morbidity and mortality rates. Like stenotic atherosclerotic lesions, AAAs accumulate inflammatory cells, but usually exhibit much more extensive medial damage. Leukocyte recruitment and expression of pro-inflammatory Th1 cytokines typically characterize early atherogenesis of any kind, and modulation of inflammatory mediators mutes atheroma formation in mice. However, the mechanistic differences between stenotic and aneurysmal manifestations of atherosclerosis remain unexplained. The investigators had recently showed that aortic allografts deficient in interferon signaling developed AAAs correlating with skewed Th2 cytokine environments, suggesting important regulatory roles for Th1/Th2 cytokine balance in modulating matrix remodeling and important implications for the pathophysiology of aortic aneurysm and atherosclerosis. Further probing of their distinct aspects of immune and inflammatory responses in vascular diseases should continue to shed new light on the pathophysiologic mechanisms that give rise to aneurysmal versus occlusive manifestations and atherosclerosis.

Cook Marks 100th Zenith Renu AAA Graft Registry Case
May 3, 2006—Cook Incorporated (Bloomington, IN) announced the completion of the 100th case in the US registry of its Zenith Renu Ancillary Graft for the treatment of patients with a migrating aortic endograft. The Zenith Renu is specifically designed for secondary endovascular intervention in patients who had previous endovascular repair of infrarenal abdominal aortic aneurysms (AAAs). The device has been used to successfully treat more than 300 AAA patients in Europe and Australia since 2002 and has been available in the US since September 1, 2005. The company noted that use of the device is a postapproval activity to document device performance data in the clinical setting.

According to the company, the Zenith Renu is available in two configurations: a main body extension and a converter to accommodate differing endograft designs. It is engineered to treat migrations in either Dacron or ePTFE membrane-based aortic endografts. Other device features include an uncovered suprarenal stent with anchoring barbs to provide strong proximal fixation and enhanced graft-to-vessel sealing and the Flexor introducer system. The device is constructed with a lightweight, strong, shrink-resistant woven synthetic polyester graft material and comes preloaded in a kink-resistant, hydrophilic delivery sheath. A trigger-wire system facilitates accurate placement, controlled release, and stabilization of the ancillary endograft during deployment, while the system's Captor hemostatic valve inhibits blood reflux.

Twelve-Month Clinical Data Presented for Lombard's Aorfix Stent Graft
April 12, 2006—Lombard Medical Technologies PLC (Didcot, Oxfordshire, UK) announced that 12-month clinical results on its Aorfix endovascular AAA stent graft were presented at the 28th Charing Cross International Symposium, which was held April 8-11 at Imperial College in London. According to the company, the follow-up data on 24 trial patients demonstrated freedom from all endoleaks, fracture, migration, or kinking. Aorfix has been used in more than 130 patients worldwide. Several of the AAA bifurcated stent grafts have exceeded 24 months of implantation with no device-related adverse clinical outcomes, the company said. The Aorfix is CE Mark approved in the EU and has obtained IDE approval from the FDA in connection with US clinical trials.

FDA Approves Medtronic's AneuRx AAAdvantage
March 27, 2006—Medtronic, Inc. (Minneapolis, MN) announced that it has received FDA approval of the AneuRx AAAdvantage abdominal aortic aneurysm (AAA) stent graft with Xcelerant delivery system. According to the company, the AneuRx AAAdvantage system offers interventionists a low profile for ease of use, a wider range of lengths and diameters, and other enhancements that allow broader patient applicability than previous generation Medtronic devices. Enhancements to the system include potentially broader proximal and distal sealing areas due to longer aortic bodies, longer and larger straight iliac limbs, and flared iliac limbs and extensions. Other features are improved radiopaque markers and contoured stents. The enhancements will provide greater patient applicability, help reduce the complexity of the procedure, and upgrade the durability of the stent graft, the company stated.

SAAAVE Becomes Law, Providing Medicare Coverage for AAA Screening
February 10, 2006—The Society of Vascular Surgery (SVS) announced that the Screening Abdominal Aortic Aneurysm Very Efficiently (SAAAVE) Act became law with President Bush's signing of S.1932, the Deficit Reduction Act of 2005, on February 8. Also known as the Budget Reconciliation Act, the law contains the key SAAAVE provisions that will implement AAA screening as a Medicare benefit. Effective January 1, 2007, SAAAVE will provide for one-time AAA screening as part of the Welcome to Medicare physical for males with any history of smoking and those with a family history of AAAs. The proposed measures for a national education and information campaign and standards sections were not included in the final bill.

The National Aneurysm Alliance (NAA), which includes the SVS, led the campaign to bring the urgent need for widespread AAA screening to the attention of Congress, and with this latest development, vascular health will be positioned at the forefront of public awareness, the SVS stated. The NAA is a coalition of medical professional organizations, foundations, patient advocates, and medical technology manufacturers dedicated to reducing the number of Americans who die each year from ruptured aortic aneurysms and other vascular diseases.

According to the SVS, the enactment of SAAAVE is a great victory for both vascular surgeons and their patients. This is the only new preventive benefit that was included in the budget reconciliation measure and is estimated to cost $200 million over 5 years. Pamela Phillips, the SVS's Director of Health Policy and Government Relations, along with representatives of the NAA, met with congressional conference committee members and staff to persuade them to support the inclusion of SAAAVE in the conference committee version of the bill and encouraged House sponsors to do the same. Congressional members had also received numerous letters from SVS members in support of this legislation. Both of these efforts influenced conference committee members to include SAAAVE in the final version of budget reconciliation.

"The members of the SVS are extremely pleased that Congress and President Bush recognize that AAA screening is an important measure that will save thousands of American lives each year," said vascular surgeon Robert Zwolak, MD, a member of the SVS Board of Directors. "Our members worked diligently on SAAAVE. These vascular surgeons concentrate their practices on the prevention and cure of vascular disease, and they know the effectiveness of screening in saving lives."

Study Reveals Cellular Activity Related to AAA Rupture
January 24, 2006—In a study published in Circulation (2006;113:438-445), Matthew M. Thompson, MD, et al concluded that a localized increase in matrix metalloproteinase-8 and -9 (MMP-8 and -9), mediated by native mesenchymal cells, presents a potential pathway for collagen breakdown and abdominal aortic aneurysm (AAA) rupture. The aim of this study was to investigate the proteolytic and cellular activity of ruptured AAAs, focusing on MMPs and their inhibitors (TIMPs). The investigators began by noting that, although it is known that AAA expansion is characterized by extracellular matrix degradation and widespread inflammation, the processes that characterize AAA rupture are not fully understood.

As detailed in Circulation, anterior aneurysm wall biopsies were taken from 55 nonruptured and 21 ruptured AAAs. A further biopsy from the site of rupture was taken from 12 of the ruptured AAAs. MMP-1, -2, -3, -8, -9, and -13, as well as TIMP-1 and -2, were quantified in each biopsy with enzyme-linked immunosorbent assay (ELISA). A comparison of anterior aneurysm biopsies showed no difference in MMP or TIMP concentrations between nonruptured and ruptured AAAs. In a comparison of ruptured AAA biopsies, MMP-8 and -9 levels were significantly elevated in the 12 rupture site biopsies compared with the 12 paired anterior wall biopsies, whereas other MMPs and TIMPs showed no difference. MMP-8 and -9 expression was mediated by native mesenchymal cells and was independent of the inflammatory infiltrate.

Edwards and Medtronic Settle Endovascular Graft Patent Infringement Lawsuit
January 23, 2006—Edwards Lifesciences Corporation (Irvine, CA) announced that it has entered into an agreement with Medtronic, Inc. (Minneapolis, MN) and Medtronic Vascular, Inc. (Santa Rosa, CA), resolving patent infringement litigation initiated in August 2003 by Edwards and Endogad Research Pty. Ltd. (Sydney, Australia), the company formed by the clinician-inventors of the patents. According to the company, the alleged infringement was of certain patents related to modular or multipart endovascular grafts especially suited for treatment of various types of aneurysms, including abdominal aortic aneurysms (AAAs). In exchange for a cash payment of $37.5 million to Edwards and Endogad, Medtronic has been granted nonexclusive licenses to the patents involved in the litigation, as well as other patents relating to endovascular AAA grafts and delivery systems.

Under the terms of the agreement, Medtronic has also purchased delivery system assets to be used with AAA grafts. Edwards and Endogad remain in litigation with Cook Incorporated (Bloomington, IN), and Gore & Associates (Flagstaff, AZ) regarding infringement of the patents that are owned by Endogad and exclusively licensed to Edwards Lifesciences. The products named in the original suit include Medtronic's AneuRx Stent Graft and Talent Stent Graft Systems, Cook's Zenith Endovascular Graft, and Gore's Excluder Bifurcated Endoprothesis, stated Edwards.

2005

Regression of AAA Linked to Inhibition of JNK Molecules
December 1, 2005—In Nature Medicine (2005;11:1330-1338), Koichi Yoshimura, MD, et al, from Yamaguchi School of Medicine in Japan reported that they have identified c-Jun N-terminal kinase (JNK) as a proximal signaling molecule in the pathogenesis of abdominal aortic aneurysms (AAAs). According to the investigators, human AAA tissue showed a high level of phosphorylated JNK. In the article, the investigators show that JNK programs a gene expression pattern in different cell types that cooperatively enhances the degradation of the extracellular matrix while suppressing biosynthetic enzymes of the extracellular matrix. Selective inhibition of JNK in vivo not only prevented the development of AAA but also caused regression of established AAA in two mouse models. Thus, JNK promotes abnormal extracellular matrix metabolism in the tissue of AAA and may represent a therapeutic target, the investigators stated.

Congress Moves Toward Coverage for AAA Screening
November 3, 2005—The US Senate voted unanimously to support a measure that would provide coverage for ultrasound screening for abdominal aortic aneurysms (AAAs) under part B of the Medicare program. The provision was voted as amendment S.2419 and included as section 6117 to Senate bill S.1932, which is known as the Deficit Reduction Omnibus Reconciliation Act of 2005. Senator Rick Santorum (R-PA) was the primary sponsor of the amendment. The omnibus bill was approved by the Senate, 52-47, and now goes to the House of Representatives for consideration.

The measure, if passed into law, would apply to ultrasound screenings for AAAs performed on or after January 1, 2007. Coverage would be limited to a one-time ultrasound screening by a qualified technologist of any Medicare beneficiary who has had a "Welcome to Medicare" physical and who manifests certain risk factors for cardiovascular disease as determined by the US Preventive Services Task Force (such as evidence of atherosclerosis, hypertension, or a history of smoking). In addition to the AAA screening program, the legislation provides for a national educational and information campaign to be carried out by the Secretary of Health and Human Services in consultation with relevant national medical societies to promote awareness among health care practitioners and the general public with respect to the importance of early detection and treatment of AAAs. The Secretary would be authorized to make appropriate grants of money to national medical, vascular technologist, and sonographer societies for AAA education programs for practitioners and providers.

The current legislation is a modification of a bipartisan initiative originally known as the SAAAVE (Screen Abdominal Aortic Aneurysms Very Efficiently) Act of 2005, which was introduced in the Senate as S.390 and the House of Representatives as H.R.827 earlier this year (Endovascular Today, March 2005). Congressional leaders for the SAAAVE provisions have been Senators Jim Bunning (R-KY) and Christopher Dodd (D-CT), who were cosponsors of the current amendment. In the House, Representatives John Shimkus (R-IL), Gene Green (D-TX), and Ron Lewis (R-KY) introduced SAAAVE. The SAAAVE legislation has been supported by a number of medical professional societies including the Society for Vascular Surgery and the Society of Interventional Radiology, as well as patient advocates, foundations, and medical technology manufacturers.

CardioMEMS Launches Endosure Wireless AAA Pressure Measurement System
November 1, 2005—CardioMEMS, Inc. (Atlanta, GA) announced that the FDA has granted 510(k) clearance for the EndoSure Wireless AAA Pressure Measurement System for measuring intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair and for use as an adjunctive tool in the detection of intraoperative endoleaks. An immediate US market launch was also announced.

According to the company, the FDA approval is based upon completion of the APEX (Acute Pressure measurement to confirm aneurysm EXclusion) clinical trial. In the study, more than 100 patients in Brazil, Argentina, Canada, and at nine hospitals in the US successfully received an EndoSure sensor at the same time they had a stent graft inserted to repair their aortic aneurysm. Implantation of the EndoSure Wireless AAA Pressure Sensor did not lead to any adverse events in the clinical trial. Last June, Co-Principal Investigator, Takao Ohki, MD, who performed the first implantation of the sensor in a patient, presented preliminary results of the APEX trial at the Society of Vascular Surgery annual meeting in Chicago.

The company stated that the EndoSure Sensor is the first wireless, unpowered, permanently implantable pressure sensor for human use to be commercially available in the US. The system is based on recent innovations in both microelectromechanical systems (MEMS) and wireless technologies. The system comprises the EndoSure Sensor, a unique delivery catheter, the external interrogation device, and proprietary software. The EndoSure Wireless AAA Pressure Sensor is implanted during the endovascular aortic repair procedure and is compatible with all commercially available stent grafts. Accurate pressure measurements within the aneurysm sac can be taken simply and efficiently, the company stated. To take a measurement, the physician places the antenna on the patient's abdomen and activates the sensor using low-power radiofrequency energy. A real-time, high-resolution pressure waveform is quickly displayed on a 15-inch, flat-panel, touch screen monitor.

"The implantation of the EndoSure is straightforward and safe," commented Dr. Ohki. "I believe that over time this important new technology may demonstrate its value by helping physicians confirm that aneurysms have been effectively treated with EVAR procedures and also identify problems that may arise."

CE Mark Granted for Cook's Zenith Endograft for Complex AAAs
October 25, 2005—Cook Incorporated (Bloomington, IN) announced that the Zenith Fenestrated AAA Endovascular Graft has received CE Mark certification, making it commercially available in the EU to treat complex abdominal aortic aneurysms. According to the company, the Zenith's design incorporates tailored openings or scallops called fenestrations in the top section of the endograft, which allow the self-expanding stent graft to treat aortic and aortoiliac aneurysms extending close to the renal and superior mesenteric arteries, which are then stented to reduce the risk of restricting or blocking critical blood flow to the kidneys and bowel. Each fenestrated device is custom-made to suit individual patients' anatomy. The Zenith design features include suprarenal fixation with anchoring barbs to ensure maximal stability and graft-to-vessel sealing, woven polyester graft material that is lightweight, strong, and shrink-resistant, and the H&L-B One-Shot Introducer System that allows simple, accurate deployment and positioning of the graft, the company stated.

"For the first time, we're seeing the possibility of offering safe, effective endovascular treatment for diseases affecting the more proximal aorta," said Roy K. Greenberg, MD, US Principal Investigator. "As branch technology joins the fenestrated family, the entire aorta falls within the domain of aortic interventionists."

Early Outcomes of Endovascular Repair of Ruptured AAAs Examined
October 1, 2005—In the Journal of Vascular and Interventional Radiology (JVIR. 2005;16:1309-1312), Michael Brandt, MD, et al from University Hospital Schleswig-Holstein in Kiel, Germany, published their findings from a retrospective review of 39 consecutive patients treated for ruptured abdominal aortic aneurysms (AAAs) from 2001 to 2004. The investigators examined the impact of the introduction of endovascular treatment on the early outcomes of ruptured AAAs and assessed the suitability of acute endovascular aneurysm repair (EVAR) in patients with ruptured AAAs.

The patients were divided into two groups: 15 who underwent open repair from 2001 to 2002 (group I) and 24 who were treated with open repair (n = 13; 54%) or endovascular repair (n = 11; 46%) from 2003 to 2004 (group II). Hospital charts and computed tomographic scans were reviewed to evaluate the feasibility of EVAR. Age, gender, and aneurysm size were similar between the two groups.

The 30-day mortality rates were 53% in group I and 8% in group II. Median procedure times were shorter in the patients who underwent EVAR. Intensive care unit stay and hospital stay were 22 days and 29.7 days, respectively, in group I, and 5.6 days and 16.1 days, respectively, in group II. Eleven patients were found ineligible for EVAR as a result of an unsuitable neck (n = 5), iliac arteries (n = 3), or both (n = 3). No graft failures were detected during follow-up.
As reported in JVIR, the study found that after introduction of acute EVAR, a total of 46% of patients with ruptured AAAs were treated with the procedure and that, potentially, 54% of patients could have been suitable for EVAR. Dr. Brandt et al concluded that endovascular stent graft implantation has significantly improved outcomes in ruptured AAAs and may therefore be beneficial in the overall treatment strategy in these patients.

Poor Outcomes Shown in Mild Stroke Patients Who Do Not Receive tPA
November 1, 2005—In a retrospective analysis of data from a prospective single-center study, Eric Smith, MD, et al showed that a substantial minority of patients deemed "too good to treat" (TGT) with intravenous tissue plasminogen activator (tPA) were unable to be discharged home (Stroke. 2005;36:2497-2499). The investigators concluded that a re-evaluation of the stroke severity criteria for tPA eligibility may be indicated.

The investigators found that some of these TGT patients with mild or improving ischemic stroke symptoms who do not receive tPA have poor outcomes. The data reviewed were from a study conducted between 2002 and 2004 of 128 patients presenting within 3 hours of stroke onset. Of these patients, 41 (34%) were not given tPA because of mild or improving stroke. Of the TGT patients, 11 of 41 (27%) died or were not discharged home because of neurological worsening (n=6) or persistent "mild" neurological deficit (n=5). No single variable at presentation was associated with death or lack of home discharge. Ten of 41 TGT patients (24%) had four-point improvement in National Institutes of Health Stroke Scale score before tPA decision; these patients were more likely to have subsequent neurological worsening, the investigators stated.

Cook Launches Zenith Renu AAA Ancillary Graft for Secondary Endovascular Intervention
August 18, 2005—The Zenith Renu AAA Ancillary Graft from Cook Incorporated (Bloomington, IN) has received FDA approval and will be available to US physicians in September, the company announced. The device has been available in Europe and Australia since 2002. The Zenith Renu is specifically designed for secondary endovascular intervention in patients who have received prior endovascular repair of infrarenal abdominal aortic aneurysms (AAAs). The Zenith Renu is available in two configuration options: a main body extension and a converter; and, it has been engineered to treat migrations in either Dacron or ePTFE membrane-based aortic endografts, the company says. Utilizing an uncovered suprarenal stent with anchoring barbs, the Zenith Renu provides strong proximal fixation and enhanced graft-to-vessel sealing. The woven synthetic polyester graft material is the same strong, lightweight, and shrink-resistant material that has been used in all of Cook's Zenith endografts. The new Zenith Renu graft system also uses Cook's Flexor Introducer System that features a kink-resistant, hydrophilic delivery sheath. A trigger-wire system facilitates accurate placement, controlled release, and stabilization of the ancillary endograft during deployment, while the system's Captor Hemostatic Valve inhibits blood reflux, the company says.

Endologix to Conduct Powerlink AAA Clinical Trial
July 26, 2005—Endologix, Inc. (Irvine, CA) has received FDA approval to enroll patients in a clinical trial using its Powerlink system to treat abdominal aortic aneurysms (AAAs) in patients with large-diameter aortic necks. According to the company, if it is cleared for marketing in the US, the Powerlink system would be the only endoluminal stent graft (ELG) for use in AAA patients with aneurysm neck diameters up to 32 mm. Endologix estimates that 5% to 10% of AAA patients evaluated for minimally-invasive treatment are excluded due to a large aortic neck diameter. There are currently three FDA-approved ELG devices to treat aortic necks up to 26 mm in diameter and one ELG that is approved to treat necks up to 28 mm in diameter, the company says. Endologix says that the Powerlink system is designed with multiple main body lengths and diameters, as well as 25-mm, 28-mm, and 34-mm cuffs, and multiple limb extensions, to improve its adaptability to variations in patient anatomies.

The company also announced that the FDA has allowed inclusion of a large-diameter Powerlink ELG in the ongoing suprarenal arm of its clinical study, which the company says should accelerate enrollment and permit physicians to treat patients who cannot be treated with an FDA-approved ELG. Endologix also received approval to initiate a seven-center, 60-patient protocol using a large-diameter infrarenal cuff with its approved Powerlink bifurcated device. These two studies will permit Endologix to study alternative implant strategies to treat this subset of patients, the company says. Endologix expects to begin enrollment in both studies in the third quarter of 2005.

PIVOTAL Trial Will Study Early EVAR for Small AAAs
July 7, 2005—The Cleveland Clinic and Medtronic, Inc. (Santa Rosa, CA) separately announced commencement of the largest US clinical trial to determine if early endovascular aneurysm repair (EVAR) after diagnosis of small abdominal aortic aneurysms (AAAs) is preferable to waiting and monitoring the growth of the aneurysm before intervening.

PIVOTAL (Positive Impact of EndoVascular Options for Treating Aneurysms Early) is a multicenter, prospective, randomized trial comparing early stent graft intervention to medical surveillance. PIVOTAL will be conducted at 70 centers in the US and will enroll approximately 1,680 patients. Half of the patients diagnosed with aneurysms between 4 cm and 5 cm will be randomized to immediate EVAR using Medtronic's AneuRx abdominal aortic stent graft system. The other half will be monitored with ultrasound every 6 months. Those in the surveillance group who develop symptoms or experience enlargement can be treated with either an open or endovascular repair procedure. The two groups will be observed for 5 years to track differences in outcomes as they relate to any aneurysm or aneurysm repair.

PIVOTAL's primary endpoint is the cumulative occurrence of the composite of rupture or aneurysm-related death within 3 years. Secondary endpoints include all-cause mortality and aneurysm-related mortality in smokers versus nonsmokers, aneurysm rupture, duration of hospital stay, procedure duration, and many other endpoints related to the use of the stent graft.

"The advent of a minimally-invasive approach with stent grafts may offer an option that is reasonable for smaller aneurysms," said Kenneth Ouriel, MD, of the Cleveland Clinic and Principal Investigator of the trial. "This contention, however, must be proven with a clinical study."

UK, Dutch Trials Show Short-Term EVAR Advantages Are Not Sustained
June 23, 2005—Four-year follow-up results from two related British trials comparing the safety, efficacy, and durability of endovascular aneurysm repair (EVAR) versus open surgery and nonintervention for the treatment of abdominal aortic aneurysms (AAAs) have been published by Professor Roger M. Greenhalgh, MD, and colleagues in The Lancet (2005;365:2179-2192). The multicenter, randomized, controlled trials for patients fit for open repair (EVAR-1) and for high-risk patients considered unfit for major surgery (EVAR-2) comprised 1,420 patients at 42 hospitals in the UK under the direction of Professor Greenhalgh at London's Charing Cross Hospital.

Last year, EVAR-1 showed in 30-day follow-up results that endovascular repair was demonstrably better for the treatment of AAAs than open surgical procedures, but now those initial overall advantages are shown to be unsustained over time. Conversely, the difference in aneurysm-related death favors endovascular repair, with the EVAR-1 trial demonstrating that the operative mortality benefit of 3% at 30 days is maintained at 4 years.

In EVAR-1, the researchers compared EVAR to open surgery in terms of mortality, durability, health-related quality of life (HRQL), and costs for patients with large AAAs. The primary endpoint was all-cause mortality, with secondary endpoints of aneurysm-related mortality, HRQL, postoperative complications, and hospital costs.
The study found that four years after randomization, all-cause mortality was similar in the two groups (about 28%), although there was a persistent reduction in aneurysm-related deaths in the EVAR group (4% vs 7%). The proportion of patients with postoperative complications within 4 years of randomization was 41% in the EVAR group and 9% in the open repair group. After 12 months, a negligible difference in HRQL existed between the two groups. The mean hospital cost per patient up to 4 years was £13,257 for the EVAR group versus £9,946 for the open repair group.

The researchers concluded that, compared with open repair, EVAR offers no advantage with respect to all-cause mortality and HRQL, is more expensive, and leads to a greater number of complications and reinterventions. However, it does result in a 3% better aneurysm-related survival. The continuing need for interventions mandates ongoing surveillance and longer follow-up of EVAR for detailed cost-effectiveness assessment, according to the authors.

In the EVAR-2 trial, as reported in The Lancet, endovascular treatment to exclude AAAs was introduced for patients of poor health status considered unfit for major surgery. EVAR-2 sought to identify whether EVAR improves survival compared with no intervention in patients unfit for open repair of AAAs. The primary endpoint was all-cause mortality, with secondary endpoints of aneurysm-related mortality, HRQL, postoperative complications, and hospital costs. Analyses were by intention to treat.

Professor Greenhalgh and colleagues reported that 197 patients underwent aneurysm repair (versus 47 who were assigned to no intervention) and 80% of patients adhered to protocol. The 30-day operative mortality in the EVAR group was 9% and the no-intervention group had a rupture rate of nine per 100 person years. By the end of follow-up, 142 patients had died, 42 of aneurysm-related factors; overall mortality after 4 years was 64%. There was no significant difference between the EVAR group and the no-intervention group for all-cause mortality. There was also no difference in aneurysm-related mortality. The mean hospital costs per patient over 4 years were £13,632 in the EVAR group and £4,983 in the no-intervention group, with no difference in HRQL scores.

The authors' interpretation of the findings was that EVAR had a considerable 30-day operative mortality in patients already unfit for open repair. EVAR did not improve survival over no-intervention and was associated with a need for continued surveillance and reinterventions, at substantially increased cost. Finally, they concluded that ongoing follow-up and improved fitness of these patients is a priority.
"The EVAR trial results will affect clinical practice at once. There will be cautious enthusiasm for the use of EVAR in low-risk patients, but personally I shall not offer EVAR in high-risk patients," Professor Greenhalgh said. "An important minority of patients are anatomically unsuited for EVAR in our current state of knowledge, and surgeons must still be trained to do open aneurysm repair. Vascular specialists of the future will need operative and catheter skills to be able to manage all problems."
In The New England Journal of Medicine (2005;352:2398-2405), Jan D. Blankensteijn, MD, and colleagues for the Dutch Randomized Endovascular Aneurysm Management (DREAM) Trial Group, reported that 2-year outcomes after conventional open repair versus endovascular repair of AAAs showed no significant differences in overall survival, although there was a difference in aneurysm-related death in favor of endovascular repair.

As in the British EVAR-1 trial, the smaller DREAM study of 351 patients reported last year that 30-day outcomes were demonstrably better for elective endovascular treatment of AAAs than for conventional open repair. Now, however, the DREAM group reports that at 2 years after randomization, the perioperative survival advantage with endovascular repair compared to open repair is not sustained after the first postoperative year. The cumulative survival rates were 89.6% for open repair and 89.7% for endovascular repair. The cumulative rates of aneurysm-related death were 5.7% for open repair and 2.1% for endovascular repair (P=.05). As reported in the NEJM, this advantage of endovascular repair was entirely accounted for by events occurring in the perioperative period, with no significant difference in subsequent aneurysm-related mortality. The rate of survival, without moderate or severe complications, was also similar in the two groups at 2 years (65.9% for open repair and 65.6% for endovascular repair). The multicenter, randomized trial studied 351 patients diagnosed with AAA with diameters of 5 cm or greater who were considered suitable candidates for both techniques.

"The results of the DREAM trial at 2 years indicate that endovascular repair is still advantageous over open repair when aneurysm-related death is considered." said DREAM coauthor Hence J.M. Verhagen, MD, PhD, vascular surgeon at the University Medical Center, Utrecht, The Netherlands. "In terms of overall survival, however, this difference seems to be cancelled out by excess mortality from other causes, mainly cardiovascular, in the endovascular-treated group."

Dr. Verhagen added, "Whether this new finding will affect the choice of treatment remains to be seen and will probably rely much more on results after a longer follow-up period, but those will not be available for some time. At present, the choice of the preferred treatment will still be made after careful consideration of the pros and cons of the two treatment modalities for every individual patient. The 2-year DREAM results may, however, influence the personal preference of the patient, family, or surgical team."

Vascutek Launches Anaconda AAA Stent Graft in Europe
April 5, 2005—Vascutek, a Terumo company, (Glasgow, Scotland, UK) announced the European introduction of the Anaconda AAA stent graft system. According to the company, the system has been CE marked based on the results from a clinical trial begun in June 2002, with patient follow-up out to 24 months and a mean follow-up of 13.5 months. The company described the Anaconda as an intuitive and modular design, which is repositionable and flexible. Anaconda is close to concluding a phase 1 IDE study in the US, the company says

Bolton Medical's Relay Thoracic Stent Graft Receives CE Mark
April 8, 2005—Bolton Medical (Sunrise, FL) has received CE Mark approval for its Relay Thoracic Stent Graft and Transport Delivery System. The Relay, according to the company, is designed to be able to treat the specific challenges associated with lesions in the thoracic aorta, particularly in the arch area. Reaching the site of the lesion is achieved by the Transport Delivery System, which the company says is designed to navigate through the femoral and iliac entry sites but still be flexible enough to accommodate any severe angles and tortuosity associated with the thoracic arch. The Relay is currently being tested in clinical trials in the US.

Medtronic Xcelerant Used With Talent AUI Introduced in Europe
April 8, 2005—Medtronic, Inc. (Santa Rosa, CA) has announced the market availability of the Xcelerant Delivery System for use with the Talent Aorto Uni-Iliac (AUI) Stent Graft System. The Talent AUI Stent Graft System is approved for use outside the US for the treatment of abdominal aortic aneurysms (AAAs), according to the company. The Talent AUI system with the CoilTrac delivery system has been available outside the US since 1999. The Xcelerant Delivery System, the company says, features an improved catheter material and integrated deployment handle to enhance trackability, improve kink resistance, and decrease deployment force.

Hence J. M. Verhagen, MD, and colleagues at University Hospital, Utrecht, The Netherlands, successfully performed the first worldwide implant of the Talent AUI Stent Graft using the Xcelerant Delivery System. They performed the implant on a patient with extremely tortuous iliac arteries, and the system performed as expected, the company says.

"The trackability of the Xcelerant Delivery System is phenomenal, and this is particularly important when you are dealing with challenging anatomies," said Dr. Verhagen. "The delivery is smooth, easy, and very precise."

Depending on anatomical and other considerations, AUI systems can be used in place of AAA bifurcated systems. These considerations may include large bilateral common iliac artery aneurysms, iliac arteries that are not uniform in size, extremely tortuous or highly diseased iliac arteries, or tight distal aortic necks in which bifurcated AAA devices are not feasible. The Talent AUI system comes in a variety of combinations and configurations that allow the physician to tailor the device to the individual patient. The two-piece AUI design has interchangeable proximal and distal components to allow quick, convenient treatment of a broad range of anatomical diameters and lengths.

Gore TAG Thoracic Endoprosthesis Receives FDA Marketing Approval
March 24, 2005-The FDA has granted W.L. Gore & Associates Inc. (Flagstaff, AZ) approval to market the Gore TAG Thoracic Endoprosthesis, the first device of its kind approved in the US for treatment of patients with aneurysms in the descending thoracic aorta. The company says that observed rates from the Gore TAG Device Pivotal Study demonstrated the Gore TAG Device group had lower operative paraplegia/paraparesis (3% vs 14%), lower operative mortality (1% vs 6%) and significantly less average procedural blood loss (472 mL vs 2,402 mL) as compared to the open surgical control group. The Gore TAG Device group experienced a 66% reduction in aneurysm-related death and had no aneurysm ruptures through 2 years. Furthermore, the company notes, patients who received the Gore TAG Device were able to return to normal activity in less time than those undergoing open surgery (30 days vs 78 days).

Michael D. Dake, MD, performed the first post-FDA approval procedure using the Gore TAG Endoprosthesis at the University of Virginia Health System Hospital (Charlottesville, VA), where Dr. Dake is Chair of Radiology. "Today marks the beginning of a new era of less-invasive repair of thoracic aortic aneurysms, which will provide a safer alternative to traditional surgery in some patients," Dr. Dake said. "Ultimately, the use of this technology may be expanded to manage a variety of challenging aortic diseases with less risk and offers new hope for improved results over current treatment of patients."

CE Mark for Medtronic's Valiant Thoracic Stent Graft
March 21, 2005—Medtronic, Inc. (Santa Rosa, CA) has announced CE Mark approval for the Valiant Thoracic Stent Graft with Xcelerant Delivery System as of March 2005. Medtronic conducted preclinical studies with endovascular pioneers Rodney White, MD, vascular surgeon at Harbor-UCLA Medical Center (Torrance, CA), and Mark Farber MD, vascular surgeon at the University of North Carolina at Chapel Hill (Chapel Hill, NC).

Dr. White commented, "The Valiant System is based on the Talent platform, which has a long history of proven results. With the changes Medtronic has made, the preclinical testing demonstrated excellent conformability and deliverability, essential benefits physicians need to confidently treat challenging thoracic anatomy. It will be interesting to compare the results of the first clinical implants that are planned to occur in Europe later this spring." Dr. Farber added, "The new Valiant graft is promising in that it addresses a number of thoracic treatment challenges that currently have no solution. A choice of fixation options, the largest diameters and multiple lengths are especially important for applicability in various disease states. The Xcelerant delivery system is similar to the one already being used on the AneuRx and Talent AAA devices."

Medtronic is planning for a US clinical trial of the Valiant Thoracic Stent Graft with Xcelerant Delivery System to occur in the next 12 months.

2004

Bolton to Commence Phase I TAA Trial
December 8, 2004—Bolton Medical (Sunrise, FL) was authorized by the FDA to commence a Phase I clinical trial of its Relay TAA Stent Graft to evaluate the device's preliminary safety and performance. The study will encompass 30 patients at five investigational sites. The focus of the clinical trial will be the endovascular treatment of various forms of thoracic aortic aneurysms. An expanded Phase II trial is planned.

According to the company, the Relay TAA Stent Graft was designed to accommodate the specific challenges of the thoracic aortic arch. The Relay is delivered endovascularly to the target site using the Transport delivery system, which is designed to be able to navigate through the tortuous small femoral and iliac entry sites, but still be flexible enough to accommodate the severe angles associated with the thoracic arch.

FDA Approves Endologix Powerlink System
November 1, 2004—Endologix, Inc. (Irvine, CA) has received FDA approval for commercial distribution of the Powerlink System, an endoluminal stent graft for the treatment of abdominal aortic aneurysms (AAAs). The Powerlink System features a one-piece, bifurcated design, with a one-piece, cobalt-chromium alloy cage, single-wire main body construction, and a minimally invasive delivery mechanism. The standard FDA conditions for approval apply: continued postmarketing surveillance and annual update reports to the FDA and physician-users.

FDA approval of the Powerlink System centered on the results of the Endologix pivotal clinical trial of 192 test patients and 66 controls treated by conventional open surgery. The Powerlink System was successfully deployed in 97.9% of test patients. Thirty-day postoperative mortality rates for the Powerlink System were 1.04% versus 6.06% for surgery. Mean length of hospital stay was 3.3 days versus 9.5 days in the control group. The trial also demonstrated significantly lower operative time, blood loss, and ICU stay for the Powerlink System patients versus the surgical patients. Thirty-three percent of Powerlink patients were treated with a regional or local anesthesia.
The Powerlink results included negligible device migration, low endoleak rate, and no reported AAA ruptures, wire form fractures, or material failures of the device. At 24 months, core lab analysis showed that in 98.6% of patients the maximum diameter of the aneurysm sac decreased (63.9%) or remained stable (34.7%).

Cook Launches AAA Practice Builder Kit
November 19, 2004—Cook Incorporated (Bloomington, IN) introduced the Abdominal Aortic Aneurysm (AAA) Physician Practice Builder Kit at the 2004 VEITHsymposium in New York City. The kit is designed to provide a comprehensive set of tools and information for health care professionals to communicate to patients the nature and treatment options of AAA and to enhance understanding of AAA among physicians' referral networks. Among the kit's features are templates for physician-to-physician introductory and follow-up letters, AAA screening instructional sheets, patient education brochures, and a patient video.

FDA Approves Endologix Powerlink System
November 1, 2004—Endologix, Inc. (Irvine, CA) has received FDA approval for commercial distribution of the Powerlink System, an endoluminal stent graft for the treatment of abdominal aortic aneurysms (AAAs). The Powerlink System features a one-piece, bifurcated design, with a one-piece cobalt-chromium alloy cage, single-wire main body construction, and a minimally invasive delivery mechanism. The standard FDA conditions for approval apply: continued postmarketing surveillance and annual update reports to the FDA and physician-users.

FDA approval of the Powerlink System centered on the results of the Endologix pivotal clinical trial of 192 test patients and 66 controls treated by conventional open surgery. The Powerlink System was successfully deployed in 97.9% of test patients. Thirty-day postoperative mortality rates for the Powerlink System were 1.04% versus 6.06% for surgery. Mean length of hospital stay was 3.3 days versus 9.5 days in the control group. The trial also demonstrated significantly lower operative time, blood loss, and ICU stay for the Powerlink System patients versus the surgical patients. Thirty-three percent of Powerlink patients were treated with a regional or local anesthesia.

The Powerlink results included negligible device migration, low endoleak rate, and no reported AAA ruptures, wire form fractures, or material failures of the device. At 24 months, core lab analysis showed that in 98.6% of patients the maximum diameter of the aneurysm sac decreased (63.9%) or remained stable (34.7%).

EVA To Begin AAA Endostaple Human Testing
October 21, 2004—EndoVascular Associates Incorporated (EVA, Bethesda, MD) has received FDA approval to undertake initial human testing of the company's endovascular AAA Endostaple repair device. The Endostaple is intended to work as an enabling technology to prevent or correct endoleak issues associated with currently available devices for endovascular aneurysm repair. Human testing is expected to begin in the first quarter of 2005 at three US centers.

EVA also announced that the National Institutes of Health has issued a Phase I grant that will allow the company to begin work on work on a second-stage device that would combine EVA's Endostaple with an unsupported, or nonstented, graft.

Cook to Launch New AAA Graft System Q4 2004
October 4, 2004—Cook Incorporated, Inc. (Bloomington, IN), has announced that the next generation of its AAA platform, which includes the Zenith Flex AAA endograft system and the H&L-B One Shot delivery system, has received FDA approval. The system will be available for shipment in the fourth quarter of this year. At this year's TCT meeting, Barry Thomas, Global Leader of Cook's Endovascular Therapies Group, met with Endovascular Today to discuss the new features of the system and Cook's plans regarding its AAA products and programs. Mr. Thomas described the Zenith Flex as having more widely spaced stent bodies to allow the device to better conform to tortuous anatomy. The H&L-B One Shot Delivery System features a double-valve system--the Captor Hemostatic Valve--to inhibit blood reflux and air aspiration, and Mr. Thomas described the system's Flexor introducer as having a sheath construction that combines flexibility with resistance to kinking or compression. The improvements in graft design and introduction have also been applied to Cook's TX2 thoracic device and to fenestrated versions of each system, which are currently being evaluated in clinical trials.

Cook will soon initiate a practice builder program designed to help AAA specialists develop and maintain a communicative network with general practitioners in their regions. The company will also be unveiling a screening program that will include lobbying Congress to encourage reimbursement for AAA screenings; the program will promote AAA awareness and diagnosis by conducting free regional screenings in a number of US communities.

Gore Introduces New Excluder AAA System
October 4, 2004—W.L. Gore & Associates, Inc. (Flagstaff, AZ), has announced the availability of its low permeability Excluder Endoprosthesis--the latest generation of its Excluder product line. The company reports that the new Excluder employs a microstructure technology that results in significantly reduced permeability during AAA treatment. The device is composed of a durable, ePTFE graft; a low-permeability film layer; ePTFE reinforcing film; an electropolished nitinol stent; and bonding film for stent-to-graft attachment.

FDA Endovascular Graft Testing Workshop
July 13, 2004—The FDA will hold its second Workshop on Preclinical Testing for Endovascular Grafts July 28 to July 29 in Gaithersburg, Maryland. Representatives from various areas involved with the development, testing, and use of endovascular grafts have been invited. There will be four sessions during the workshop: (1) animal studies; (2) fixation effectiveness and sealing; (3) implant integrity; and (4) past, present, and future issues in preclinical testing. Each session will begin with short presentations, which will be followed by discussion from the participants and audience members. For more information, please visit http://www.evtoday.com/Pages/News.html, where you will also find a questionnaire for clinicians regarding endovascular graft experience.

Cook Set to Begin Fenestrated AAA Device Trial
July 15, 2004—Cook Incorporated (Bloomington, IN) has received FDA approval to begin investigational use of a fenestrated version of its Zenith endovascular graft for complex AAAs. The company reports that the fenestrated devices are highly customized to meet the anatomic needs of each patient. Scallops at the top and fenestrations in the walls of the graft allow it to be implanted precisely in the aorta across adjacent vessels without blocking blood flow through those vessels.

The FDA approved Cook's Investigational Device Exemption application for clinical studies at five US medical institutions involving 25 patients. The Zenith fenestrated graft is approved for sale in Australia and is available as a custom device in Europe.

Medtronic Launches New AneuRx Graft Material; Receives CE Mark for Xcelerant Delivery System
July 14, 2004—Medtronic, Inc. (Santa Rosa, CA), has announced the availability of its new Resilient graft material for its AneuRx AAA Stent Graft System. The company comments that the Resilient material provides the device with higher density graft material designed to reduce porosity and improve durability. The enhanced AneuRx marks the fourth generation of the device.

"I have always been a big fan of the AneuRx stent graft due to its proven durability and versatility," stated Takao Ohki, MD, Chief of Vascular Surgery at Montefiore Medical Center in New York. "I also believe that the new material, which is 52% more dense, on average, will only improve the long-term durability and outcome."

Medtronic has also received CE Mark approval for its Xcelerant Delivery System, which is designed for use with the company's Talent AAA system. The Talent system is available for sale outside the US. The company comments that the Xcelerant Delivery System features an improved catheter material and integrated deployment handle to enhance trackability, improve kink resistance, and dramatically decrease deployment forces.

First Vascutek Anaconda Grafts Implanted in US
July 9, 2004—Vascutek (a Terumo company) has announced the commencement of its phase I FDA study for the Anaconda Endovascular Device. The Anaconda has been developed for the treatment of infrarenal aortic aneurysms and is a modular system constructed of polyester graft material and self-expanding nitinol ring-stents. The company comments that it features a fully repositionable, woven polyester body, which is sealed in the infrarenal neck by two flexible, conformable nitinol ring-stents, and is anchored in position by four pairs of nitinol hooks. The two separately deployed legs are supported by individual, flexible, kink-resistant nitinol ring-stents.

The first patient was successfully treated at the Cleveland Clinic by Roy K. Greenberg, MD; two further successful cases were also carried out at the same institution. "The Anaconda device may offer advantages over other commercially available devices currently on the market; among them is proximal stent reconstrainability and the potential to angle the proximal stent within a somewhat tortuous neck," said Dr. Greenberg. "These may allow for the treatment of patients with more complex proximal neck anatomy."

The other three phase I centers and participating physicians are the University of Pennsylvania, where Ronald Fairman, MD, and Jeffrey Carpenter, MD, serve as the trial's national principal investigators, the University of Southern Illinois (Kim Hodgson, MD), and Georgetown University (David Deaton, MD). "We are excited about the Anaconda device clinical trial," commented Drs. Fairman and Carpenter. "With its ability to be repositioned and canted within the aortic neck, it addresses a number of the remaining challenges of infrarenal endografting."

"Vascutek is delighted to begin our clinical program in the US," said Stuart Rodger, Vice President, Clinical Affairs. "Furthermore, we are close to completing enrollment of patients in the European Anaconda Study. We have followed a cautious and prudent path with the Anaconda. We will analyze the data from our European study, and we will not apply the CE mark until the clinical evidence supports that decision."

Two-Year Zenith AAA Data Announced
June 7, 2004—Cook Incorporated (Bloomington, IN) has released the 2-year US clinical trial data for its Zenith AAA endovascular graft. The trial included 352 patients treated at 15 centers. According to the company, among the results are a 97.7% survival rate; 0% stent migration (≥10 mm) in both standard and high-risk patients; 7.5% rate of endoleak (any type), with a 6.9% rate in standard patients; and the diameter of aneurysms remained unchanged or decreased in 97.4% of all patients and in 100% of patients without endoleaks or systemic infection.

Cook Introduces Next-Generation Zenith Flex; Coda Balloon Catheter
June 3, 2004—At this year's annual meeting of the Society for Vascular Surgery in Anaheim, held June 3-6, Cook Incorporated (Bloomington, IN) unveiled its next-generation Zenith Flex AAA Endovascular Graft. Before launching the new Zenith Flex endograft, Cook is waiting for FDA clearance on a new delivery system designed to take full advantage of the new endograft's advanced features. FDA clearance of the delivery system is expected soon.

Cook also recently launched its Coda Balloon Catheter for temporary occlusion of large vessels and the expansion of vascular prostheses. The catheter has a 10-F shaft size that provides stability and allows for a large inflation lumen.