Healthcare Industry News: drug-eluting stent
News Release - March 20, 2007
Cordis Corporation to Emphasize Commitment to Interventional Cardiology at ACC.07Cordis Adds to Growing Body of Long-term Clinical Evidence for CYPHER(R) Sirolimus-Eluting Coronary Stent, Showcases Recently Launched REGATTA(TM) Steerable Guidewire Family, and Shows Potential for Biologics Delivery Systems
MIAMI LAKES, Fla., March 20 (HSMN NewsFeed) -- Cordis Corporation will highlight its commitment to the practice of interventional cardiology at the upcoming American College of Cardiology's 56th Annual Scientific Session (ACC.07) in New Orleans from March 24-27.
During this worldwide medical conference, cardiologists will have access to emerging and long-term clinical evidence about the CYPHER® Sirolimus- eluting Coronary Stent and new clinical data involving the use of the NOGA® XP Cardiac Navigation System, from Cordis Corporation's Biologics Delivery Systems, for the targeted delivery of adult stem cells to the heart. In addition, Cordis will showcase the REGATTA(TM) Steerable Guidewire family, its latest approved cardiovascular technology to enable interventional cardiologists to improve patient care.
"ACC.07 will serve as backdrop for the presentation of important registries and randomized clinical trials-the gold standard for clinical evidence-for the CYPHER® Stent. Together, they will further clinical understanding about the CYPHER® Stent and other products that are part of the Cordis Cardiology family, such as the NOGA® XP Cardiac Navigation System," said David E. Kandzari, M.D., F.A.C.C., F.S.C.A.I., Chief Medical Officer, Cordis Cardiology Division, Cordis Corporation.
"We welcome the opportunity to share with physicians new clinical data about the CYPHER® Stent to help them advance treatment for patients with coronary artery disease," Dr. Kandzari added. "ACC.07 also gives us an excellent occasion to discuss with interventional cardiologists our growing portfolio of products and services designed specifically for use in the cardiac cath lab, including the recently launched REGATTA(TM) Guidewire family."
During ACC.07, Cordis will present the five-year results of the SIRIUS Trial, a pivotal randomized trial that was part of the basis for the approval of the CYPHER® Stent in the United States in 2003 and the longest running U.S.-based randomized study for a drug-eluting stent. Other clinical data to be presented include three-year results of the ARTS II Study, a multi-center, prospective study comparing the CYPHER® Stent to coronary artery bypass grafting (bypass surgery) in patients with blockages in two or more vessels, an indication not approved in the United States for the CYPHER® Stent; and two-year results from the MATRIX Registry, which examines the long-term safety of the CYPHER® Stent in on-label and off-label indications.
ACC.07 will also feature the presentation of the PERMIT Study, the first randomized trial in the United States that investigates the use of a 3-D injection catheter in combination with the NOGA® XP Cardiac Navigation System to provide targeted delivery of adult stem cells, called skeletal myoblasts, for treating damaged heart tissue. The NOGA® XP Cardiac Navigation System, which was approved by the U.S. Food and Drug Administration in 2006, is an innovative 3-D imaging system and the only guided electromechanical cardiac navigation technology available to physicians for use in a wide variety of advanced medical procedures.
The dates and times for the clinical data presentations mentioned in this news release follow:
Sunday, March 25
PERMIT Study: This study involving the NOGA® XP Cardiac Navigation System will be presented by Nabil Dib, M.D., M.Sc., F.A.C.C., from the University of California/San Diego, during a late-breaking clinical trials session at 11:15 a.m. Central Daylight Savings Time (CDT).
Monday, March 26
ARTS II Study: This CYPHER® Stent study will be presented by Patrick W. Serruys, M.D., Ph.D., from Thoraxcenter, Erasmus Medical Center in The Netherlands, at 12 p.m. CDT.
MATRIX Registry: This CYPHER® Stent patient registry will be presented by George D. Dangas, M.D., Ph.D., from Columbia University Medical Center, during a late-breaking clinical trials presentation at 2:15 p.m. CDT.
Tuesday, March 27
SIRIUS Trial: This study examining the performance of the CYPHER® Stent versus bare-metal stents in FDA-approved indications will be presented by Martin B. Leon, M.D., from Columbia University Medical Center, at 10 a.m. CDT.
The studies are embargoed until the time of the scientific presentations.
More information about the presence of Cordis at ACC.07 can be found at http://events.cordis.com.
About the CYPHER® Stent
The CYPHER® Stent has been chosen by cardiologists worldwide to treat approximately three million patients with coronary artery disease. The safety and efficacy of the device is supported by a robust clinical trial program that includes more than 70 studies that examine the performance of the CYPHER® Stent in a broad range of patients.
Developed and manufactured by Cordis Corporation, the CYPHER® Stent is currently available in more than 80 countries and has the broadest clinical experience and longest-term clinical follow-up of any drug-eluting stent. The next version of sirolimus-eluting stent, the CYPHER® SELECT(TM) Sirolimus- eluting Coronary Stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. The CYPHER® SELECT(TM) Plus Stent, the third version of a sirolimus-eluting coronary stent, received CE Mark in 2006 and is currently available in many markets outside the United States.
For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at www.cypherstent.com.
About the REGATTA(TM) Guidewire family
The REGATTA(TM) Guidewire family provides tailored solutions for the placement of interventional devices in coronary arteries. The REGATTA(TM) Steerable Guidewires are all-purpose guidewires; the REGATTA(TM) SB Steerable Guidewires are designed to facilitate access to side branches; and the REGATTA(TM) HS Steerable Guidewires include features that ease placement in highly narrowed arteries. All versions feature a next-generation hydrophilic coating technology and a single-piece steel core wire that enhances torque. The REGATTA(TM) Guidewires and the REGATTA(TM) SB Guidewires are already available in many markets around the world. The worldwide launch of the REGATTA(TM) HS Guidewires is expected later this year.
About the NOGA® XP Cardiac Navigation System
The NOGA® XP Cardiac Navigation System from Biologics Delivery Systems, Cordis Corporation, is the most advanced technology currently available on the market to create highly precise, three-dimensional images of the heart. Based on these images, physicians are able to accurately identify tissue that could benefit from a variety of targeted therapies. The NOGA® XP Cardiac Navigation System is currently being used to map the heart in more than 17 ongoing clinical studies worldwide, investigating the use of adult stem cell and gene therapies to treat conditions such as congestive heart failure and chronic ischemia.
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease. More information about Cordis Corporation can be found at www.cordis.com.
*Cordis Corporation has entered into an exclusive worldwide license with Wyeth for the localized delivery of sirolimus in certain fields of use, including delivery via vascular stenting. Sirolimus, the active drug released for the stent, is marketed by Wyeth Pharmaceuticals, a division of Wyeth, under the name Rapamune®. Rapamune is a trademark of Wyeth Pharmaceuticals.
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