Cath Lab Digest - March 2008 - (Page 87)

MARCH 2008 STEMI INTERVENTIONS 87 Medtronic Receives FDA Approval for Endeavor Zotarolimus-Eluting Coronary Stent System M edtronic, Inc., has received approval from the U.S. Food and Drug Administration (FDA) for the Endeavor® ZotarolimusEluting Coronary Stent System to be used in the treatment of coronary artery disease. The Endeavor data encompasses the largest, most wide-ranging patient population submitted to the FDA in support of a drug-eluting stent, including more than 4,100 patients, followed up for as long as four years. This extensive clinical research has shown that Endeavor provides a consistent and sustained reduction in the need for repeat procedures compared to a bare-metal stent, while also maintaining an excellent safety profile. The Endeavor stent is the first new drug-eluting stent approved by the FDA since 2004. “Endeavor represents a true next-generation drug-eluting stent because of its unique design, which combines an advanced stent platform with the potent drug zotarolimus and a biocompatible polymer,” said Dr. Martin B. Leon, professor of medicine at Columbia University Medical Center in New York, cardiologist at New York-Presbyterian Hospital/Columbia University Medical Center, founder and chairman emeritus of the Cardiovascular Research Foundation, and principal investigator of the ENDEAVOR III and IV clinical trials. “This device addresses an important need by demonstrating comparable clinical effectiveness to a first generation drug-eluting stent while also exhibiting a safety profile more typical of a baremetal stent, long considered a benchmark for safety performance. In addition, it has the advantage of being exceptionally easy to deliver through the tortuous vessels of the coronary vasculature.” Ultimately, the ENDEAVOR clinical program will enroll more than 22,500 patients followed to five years; approximately 16,630 of these patients will receive an Endeavor stent. As a condition of FDA approval, Medtronic will continue its extensive post-market clinical program, which will now add sites in the United States to ensure that at least 5,000 patients are followed to a minimum of five years. In addition, Medtronic will collaborate with the FDA to conduct or participate in a study intended to identify the optimal duration of dual anti-platelet therapy following percutaneous intervention with the Endeavor drug-eluting stent. More information for physicians and patients is available online at www.EndeavorStent.com. ■ Sameer Mehta, MD, FACC, MBA, is studying ST-elevation myocardial infarction interventions in his work with short door-to-balloon time primary PCI and the Single INdividual Community Experience REgistry for Primary PCI (SINCERE) database at 5 community hospitals in Miami, Florida, now over 280 patients. A past chief of interventional cardiology and director of the cardiovascular laboratory at Cedars Medical Center in Miami, as well as former President of the American Heart Association (Miami Dade Division), Dr. Mehta is a Voluntary Associate Clinical Professor of Medicine at the University of MiamiSchool of Medicine. Dr. Mehta is also president of the Indo-American Society of Interventional Cardiologists (ISIC) and a course director for the Lumen-Vascular Interventions Symposium. Dr. Mehta will be commenting on the important work going on around the world as societies and their hospitals struggle to educate patients about the importance of timely intervention in ST-elevation myocardial infarction, and work collaboratively to decrease the time from patient arrival to intervention. STEMI Interventions: Commentary This month’s review of the recently published work from Ottawa, Canada, entitled “A Citywide Protocol for Primary PCI in ST-segment Elevation Myocardial Elevation” (NEJM, 2008; 358:231–240, see article abstract on next page), provides an opportunity to reflect upon numerous critical aspects that are related to the effective triage and management of patients with STEMI. The Ottawa study is the latest in the series of notable works that the NEJM has published in the last several months on the critical subject of primary PCI and regarding the dramatic global changes that are occurring in the these patients. To begin with, I want to congratulate the researchers at the University of Ottawa Heart Institute for their pioneering work. It is unambiguous how significantly this work will impact on the design of global STEMI care in large metropolitan areas. This reviewer is already involved in designing similar initiatives in several Asian cities for the effective triage and treatment of STEMI patients and the relevance of the Ottawa experience is transparent. This notable work supplements the work of several large projects from Europe and from the United States. Most notably, relevant comparisons to the Ottawa study can be made with the tremendous work that has been done at the Mayo Clinic and at the Abbott Northwestern Heart Center in Minneapolis. The Ottawa protocol is unique in several aspects: 1) It is the largest published work in STEMI interventions involving systematic primary PCI for 800,000 people living in the Ottawa metropolitan area where no patient was treated with fibrinolysis alone. Notably, this care required a redesign of the traditional care of these patients, the development of new protocols for ambulance transport, changes in physician-referral patterns, and changes in emergency department (ED) protocols. This strategy is markedly different that the pharmaco-invasive, “hub and spoke” models that are practiced at the Mayo Clinic and at the Abbott Northwestern Minneapolis, and at numerous other superb U.S. programs. It is also very different than the thrust for the very early, prehospital pure fibrinolysis or facilitated fibrinolysis strategies that are advocated by a few premier European sites. Although the role of thrombolytic therapy in the era of primary PCI continues to evolve, the Ottawa study makes a further dent in the utility of this approach. Medical Ventures to Acquire Two Vascular Device Developers M edical Ventures Corp., specializing in products for the vascular and surgical markets, has signed an agreement to acquire two vascular product development companies. The two acquisitions are BBalloon Ltd. and Neovasc Medical Ltd., both early-stage life sciences companies incubated by Israel-based Peregrine Ventures. Each company is focused on developing new technologies for the interventional treatment of heart and vascular diseases. Neovasc has developed a specialized stent for the treatment of refractory angina, and B-Balloon is developing devices used to treat ostial and bifurcation lesions in coronary and peripheral arteries. Medical Ventures’ head office will remain in Canada, while Neovasc and BBalloon’s product development activities will continue in Israel. Medical Ventures’ surgical tissue and contract manufacturing business will continue to operate within the company’s existing PM Devices division. For more information, please visit: www.medical-ventures.com. ■ Continued on the next page http://www.EndeavorStent.com http://www.medical-ventures.com

Table of Contents Feed for the Digital Edition of Cath Lab Digest - March 2008

Cath Lab Digest - March 2008 Are You Being Paid Fair Market Value in 2008? A Cardiac Cath Lab Professionals Survey by Cath Lab Digest and the Society of Invasive Cardiovascular Professionals Saint Joseph’s Hospital Invasive Imaging Tools for Optimizing Coronary Stent Deployment Contents Clinical Editor’s Corner A Workflow Revolution in Cath Lab Reporting Advantages of a New Digital Lab at Baystate Medical Center Cardiac Computed Tomography: What Does it Mean for the Cath Lab? The Latest in Cardiac Magnetic Resonance Imaging (MRI) Cellular Cardiomyoplasty and Cardiac Regeneration Intravascular Ultrasound in the Cath Lab: A Powerful — and Underutilized — Tool to Improve Patient Outcomes The Stentplus™ Patient Success Program Cardiac Cath Lab Clutter — or, Spring into Action! Groin Bleeds and Other Hemorrhagic Complications of Cardiac Catheterization: A List of Relevant Issues Ask the Clinical Instructor: A Q&A Column for Those New to the Cath Lab What Do You Think? Experience with a New Guidewire: The Terumo Runthrough NS The Ostial Pro™ Stent Positioning System: Perfecting Aorto-Ostial Stent Placement Precious Minutes The Ten-Minute Interview with…Mark Bowles, BSN, CCRN Vascular Care in the Cath Lab: Planning a Smooth Transition Cath Laughs CMS 2008 OPPS Final Rule Review An Extensive Set of Review Courses for the CCI Basic Science, Non-Invasive Echocardiography and Vascular, and ARDMS Ultrasound Exams Meetings Calendar CEU Education Center Clinical & Industry News STEMI Interventions Classifieds Advertisers Index

Cath Lab Digest - March 2008

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