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Boston Scientific and Guidant Sign $27 Billion Merger Agreement
January 25, 2006—Boston Scientific Corporation (Natick, MA) and Guidant Corporation (Indianapolis, IN) announced that the Board of Directors of Guidant has unanimously approved and entered into the merger agreement provided to Guidant by Boston Scientific on January 17. Under the agreement, Boston Scientific will acquire all outstanding shares of Guidant for a combination of cash and stock worth $80 per Guidant share, or approximately $27 billion in aggregate. Guidant shareholders will own approximately 36% of the combined company. The transaction is subject to customary closing conditions, including clearances under the Hart-Scott-Rodino Antitrust Improvements Act and the European Union merger control regulation, as well as approval by Boston Scientific and Guidant shareholders. Boston Scientific expects to complete the transaction by the end of the first quarter of 2006. As previously announced, Boston Scientific has entered into an agreement with Abbott Laboratories (Abbott Park, IL) under which Boston Scientific has agreed to divest Guidant's vascular intervention and endovascular businesses, while agreeing to share rights to Guidant's drug-eluting stent program. Boston Scientific and Guidant believe that the Abbott agreement will enable Boston Scientific and Guidant to rapidly secure antitrust approvals for the merger.
Prior to entering into this agreement with Boston Scientific, Guidant terminated its merger agreement with Johnson & Johnson (New Brunswick, NJ). Johnson & Johnson confirmed that Guidant rejected its proposal and terminated its existing acquisition agreement after Johnson & Johnson decided not to increase its latest offer. Johnson & Johnson said it did not raise its bid because to do so would not have been in the best interest of its shareholders.
"We believe the transaction and the strategic rationale for this combination are in the best interests of our patients, employees, customers, and shareholders reflecting the full value of our firm," commented James Cornelius, Chairman and Chief Executive Officer of Guidant.
Potential Stent Patent War Looms
January 26, 2006—The Wall Street Journal has reported on a potential battle for patent rights to cardiovascular stents. On December 13, 2005, the US Patent office issued Patent No. 6,974,475, to W. Henry Wall, DDS, an oral surgeon in Norcross, Georgia. The patent is for the design of a stent that Dr. Wall claims he first described in drawings in October 1984 and sent to his patent attorney. He filed his application with the patent office in December 1987, where it languished for 18 years, following rejection, appeal, and ultimately approval. He claims to have developed his concept after reading a 1981 article about Dr. Andreas R. Gruentzig's pioneering efforts in angioplasty. The Journal notes that the legal rights surrounding this patent are unclear. No one has ever made a prototype of Dr. Wall's stent, nor tested it in animals or people, but Dr. Wall claims that his patent covers most of the stents on the market today, including drug-eluting stents. Patent rights are predicated on the date of invention, not the date that the patent application was filed with the patent office. Dr. Wall claims that the date of his invention is October 15, 1984, approximately 6 weeks prior to November 25, 1984, the date that the Patent Office attributed to the stent designed by Julio Palmaz, MD, and Richard Schatz, MD.
According to The Wall Street Journal, Dr. Wall's patent lists 42 claims including design and deployment methods that are commonly used in commercially available stents. The patent gives Dr. Wall the right to exclude anyone from making, using, or selling any stent or method delivering a stent described in his claims. Dr. Wall's patent rights are effective as of December 13, 2005, and will not expire until 2022.
ACC Launches Innovation in Intervention: i2 Summit 2006
February 2, 2006—The American College of Cardiology (ACC) has announced the inaugural Innovation in Intervention: i2 Summit 2006 to be held concurrently with the ACC's Annual Scientific Session (ACC.06) in Atlanta on March 11-14, 2006. The i2 Summit is sponsored by a partnership of the ACC with the Society for Cardiovascular Angiography & Interventions (SCAI) and other professional associations. According to the ACC, the new summit will provide the most comprehensive annual forum for interventional cardiologists ever assembled, providing physicians specialized education using sophisticated formats, from simulations to live satellite training and interactive computer-based learning. The program will include a 1.5 day session, cosponsored by Vascular InterVentional Advances (VIVA) that will focus on peripheral vascular disease care. The i2 Summit 2006 Program Committee is cochaired by William O'Neill, MD, of William Beaumont Hospital in Michigan, Ted Feldman, MD, of Evanston Northwestern Hospital in Illinois, and William D. Knopf, MD, of Saint Joseph's Hospital in Atlanta.
The ACC notes that prospective attendees must register specifically for the i2 Summit, which will include access to both the Summit and ACC.06 events. Registering for just the ACC.06 alone will not provide access to the i2 Summit. Advance registration for both the i2 Summit and ACC Scientific Sessions closes on February 14. Further meeting details and registration information can be found online at the ACC's Web site, www.acc.org/2006ann_meeting/i2_summit/home.htm.
Guidant Receives CE Mark for Coronary DES
January 30, 2006—Guidant Corporation (Indianapolis, IN) announced that it has received CE Mark approval for the Xience V everolimus-eluting coronary stent system. The Xience V uses Guidant's cobalt-chromium Multi-Link Vision coronary stent system, which is available on the rapid-exchange platform. Acccording to the company, the everolimus drug has been shown to reduce tissue proliferation in the coronary vessels after stent implantation. The company is preparing for a European market launch in the second quarter of 2006. European approval was based on the results of the SPIRIT FIRST trial, which demonstrated the benefits of an everolimus-eluting stent, according to Principal Investigator Prof. Patrick W. Serruys, MD. In November, Guidant announced completion of enrollment of SPIRIT II, a 300-patient, randomized clinical trial evaluating Xience V. The single-blind, prospective, randomized, noninferiority study further evaluates the Xience V compared to the Taxus Express2 (Boston Scientific, Natick, MA) paclitaxel-eluting coronary stent system for the treatment of coronary artery disease. Guidant's 1,380-patient SPIRIT III global clinical trial is evaluating the Xience V Stent System in the US and Japan. The randomized US cohort, which will support an FDA premarket approval submission, is expected to complete enrollment later this quarter, the company stated.
"With this approval, physicians in Europe will have an excellent treatment option for patients requiring a drug-eluting stent," commented Dr. Serruys.
Renaissance Study Shows Efficacy of Boston Scientific's Express SD Renal Stent
January 23, 2006—Boston Scientific Corporation (Natick, MA) announced results from its Renaissance trial, which was designed to study the safety and effectiveness of the Express SD renal stent in the treatment of renal artery disease. The results were presented by the study's Principal Investigator, Krishna Rocha-Singh, MD, at the International Symposium on Endovascular Therapy (ISET), which was held in Miami Beach on January 22-26, 2006.
According to the company, Renaissance is a prospective, single-arm, multicenter study involving 100 patients at 14 sites in the US. The primary endpoint of the study is restenosis at 9 months. The restenosis rate was compared to a benchmark of 40% determined by a literature review of similar endpoints in patients undergoing balloon angioplasty of the renal artery. The restenosis rate for the Express SD was 21.3%. Dr. Rocha-Singh also reported a major adverse event rate of 10.5%, including no in-hospital events and no reported stent thromboses, and a low target lesion revascularization rate of 8.4%. The trial also demonstrated a follow-up success, with 93 of the 100 patients having ultrasound performed at 9 months postimplantation. The company stated that these results will be used to seek FDA approval for the Express SD renal stent for use in the renal arteries. The investigators will continue to monitor the progress of the study patients with annual follow-up to 5 years.
"The Renaissance study provides critical insight into the occurrence and treatment of renal artery disease," commented Dr. Rocha-Singh. "Physicians have seen poor results treating this disease with a balloon alone, so it's gratifying to see an improved outcome when incorporating the Express SD renal stent."
FoxHollow Initiates Two Studies for SilverHawk, Files IDE for Coronary Indication
January 9, 2006—FoxHollow Technologies, Inc. (Redwood City, CA) announced that it plans to launch two clinical studies related to the use of the SilverHawk Plaque Excision System in treating peripheral arterial disease. The first study will be a 100-patient independent registry. The study will include 6- and 12-month follow-up of patients using duplex ultrasound, with the results to be evaluated by an independent core lab. Enrollment is expected to be completed in the second quarter of 2006, and 6-month data will be available in the first quarter of 2007. The second study will be a randomized trial comparing outcomes in patients treated with the SilverHawk versus those treated with medical management. Enrollment is expected to be completed by the end of 2006, with initial data available by mid-2007.
FoxHollow also announced that it has filed for an investigational device exemption with the FDA to begin clinical trials with the SilverHawk in the treatment of coronary artery disease in bifurcated vessels. The company said it plans to introduce four enhancements to the SilverHawk device in 2006 that are designed to increase its effectiveness in cutting calcified plaque, its ease of use, and to increase the number of areas it treats within the legs.
Editor's Note: The eNews released on February 7, 2006, incorrect identified Michael Jaff, D.O. as directing the FoxHollow registry. Dr. Jaff has advised that he has no affiliation with that registry.
Rafael Medical Receives IDE Approval for Vena Cava Filter Trial
February 2, 2006—Rafael Medical Technologies, Inc. (Boston, MA) announced that it has received conditional Investigational Device Exemption approval from the FDA to begin the first phase of a US clinical investigation of its SafeFlo Retrievable Vena Cava Filter for the prevention of pulmonary embolism. The trial is designed to evaluate the safety and efficacy of the SafeFlo filter in both permanent and temporary indications. The trial is expected to commence shortly at two medical centers in New York City. A second phase of the trial will commence after completion of the first 10 patients in the initial phase of the US study. The clinical data will be used to support the company's final device clearance submission to the FDA. European clinical studies conducted to date at several sites indicate the potential versatility and safety of the filter as well as its retrievability up to 23 days postimplantation. The SafeFlo is approved and commercially available in select European markets.
According to the company, the SafeFlo filter is based on shape-memory nitinol wires and a design that provides an alternative anchoring mechanism to the standard strut-based designs of filters. SafeFlo's low-profile design is intended to be vessel-friendly and to afford simple and safe filter implantation with the ability to fully deploy, retrieve, and reposition prior to detachment. These attributes are intended to provide the physician with full control of the implantation procedure. The company believes that by oversizing the vessel with the filter's double ring anchoring mechanism, the SafeFlo filter has the potential for a high level of stability within the cava. A safe and fully repositionable retrievable filter could provide the needed protection at the critical stages for patients at risk to develop pulmonary embolism, the company stated.
Medtronic and Edwards Settle Endovascular Graft Patent 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 Edwards, 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.
Study Suggests Statins May Reduce Sepsis Risk in Cardiovascular Disease
January 25, 2006—Statins, in addition to their lipid-lowering function, may also reduce the risk of sepsis in patients with cardiovascular disease, according to a study published early online by The Lancet and set for publication in a future print issue of The Lancet. In the study, Daniel G. Hackham, MD, et al analyzed data from more than 69,000 people older than 65 years with cardiovascular disease. The study group was composed of patients who had been hospitalized for acute coronary syndrome, stroke, or revascularization; half had been prescribed statins after being discharged, and half had not. The data showed that after 2 years, 551 patients were admitted to hospital for sepsis in the statin group and 667 patients in the control group (71.2 events vs 88 events per 10,000 person-years, respectively). This corresponds to a 19% reduction in the relative risk of sepsis for those taking statins. The protective association between statins and sepsis persisted in high-risk subgroups, including patients with diabetes mellitus, chronic renal failure, or a history of infections. Significant reductions in severe sepsis and fatal sepsis were also observed. No benefit was noted with nonstatin lipid-lowering agents. The authors concluded that randomized trials to test statins for the prevention of sepsis are warranted.
"The use of statins in patients with atherosclerosis was associated with a significantly reduced risk of sepsis, including severe sepsis and fatal sepsis," commented coauthor Donald A. Redelmeier, MD. An accompanying commentary published online in The Lancet by Marc W. Merx, MD, Christian Weber, MD, discussed the value and limitations of this study, other possible benefits of statins, and the challenges that remain for researchers in ascertaining the therapeutic potential of statins in the prevention and treatment of sepsis.
Cellular Activity Related to AAA Rupture Revealed in Study
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 AAA expansion is known to be 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 ELISA, enzyme-linked immunosorbent assay. 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 their 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.
Study Shows Benefit of Cordis's Cypher in Complex Coronary Lesions
January 31, 2006—Cordis Corporation (a Johnson & Johnson company, Miami, FL) announced that a study published in the Journal of the American College of Cardiology (2006;47:449-455) demonstrates that the company's Cypher sirolimus-eluting coronary stent may reduce restenosis and the occurrence of major adverse cardiac events in patients with complex coronary artery lesions without increasing the risk of thrombosis. The SCANDSTENT study (Stenting of Coronary Arteries in Non-Stress/Benestent Disease) is the only randomized study examining the Cypher stent against bare-metal stents that includes complex patients, defined as patients with blockages longer than 15 mm, side-branch lesions, ostial lesions, and angulated lesions greater than 45 degrees.
Henning Kelbaek, MD, et al randomized 322 patients with angina pectoris, unstable angina, and complex lesions to treatment with the Cypher stent or a bare-metal stent. Investigators found that at 6 months the Cypher outperformed the bare-metal stent. When comparing the Cypher stent group with the bare-metal stent group, researchers found improvements in the narrowest vessel size (minimal lumen diameter of 1.63 mm vs 2.48 mm), significant reductions in narrowing of the vessel (diameter stenosis of 19.3% vs 43.8%), a dramatic reduction in narrowing of the vessel on multiple occasions (greater than 50% stenosis in main branch of 2% vs 31.9%) and significantly lower rates of target lesion revascularization (2.4% versus 29.6%). Cordis noted that the SCANDSTENT study also documented low angiographic and clinical restenosis rates with the Cypher as compared with a pooled analysis of other Cypher stent versus bare-metal stent studies, including RAVEL, SIRIUS, DIABETES, and SES-SMART studies. The Cypher was found to reduce angiographic restenosis by 80% and target vessel revascularization by 75% compared to the bare-metal stent group in the pooled analysis. In the SCANDSTENT trial, angiographic restenosis was reduced by 94%, and target vessel revascularization by 92%.
"In the first 6 months after receiving a Cypher stent, we saw significant clinical and angiographic improvement in these challenging patient cases," commented Dr. Kelbaek. "Longer term follow-up and studies of drug-eluting stents in thrombotic lesions are needed, but if these positive outcomes continue there will be few situations in which use of a bare-metal stent will be considered favorable."
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