Healthcare Industry News: peripheral artery disease
News Release - March 8, 2006
New Clinical Data for the CYPHER(R) Sirolimus-Eluting Coronary Stent In Heart Attacks and Long Lesions to Appear At ACCBroad Range of Studies At the 2006 American College of Cardiology Annual Scientific Session Showcase Variety of Technologies from Cordis Corporation
MIAMI LAKES, Fla., and WARREN, N.J., March 8 (HSMN NewsFeed) -- More than 20 clinical studies examining cardiology, endovascular and cell therapy technologies from Cordis Corporation will be presented at the upcoming 2006 American College of Cardiology Scientific Session (ACC 2006) in Atlanta, GA March 11-14. Clinical findings will be presented at late-breaking clinical trials sessions and in plenary and poster sessions throughout the four-day international cardiology meeting.
"ACC 2006 will be an exciting congress for Cordis, with compelling data expected across many frontiers," stated Dennis Donohoe, M.D., Vice President, Worldwide Regulatory and Clinical Affairs, Cordis Corporation. "The breadth of clinical data from Cordis Corporation will provide physicians and patients with new information about coronary artery disease, stroke, heart attacks and adult cell therapy, which will continue to showcase Cordis as a leader in the fields of cardiology and vascular medicine."
Among oral presentations and posters, clinical investigators will report on the first randomized trial clinical examining the use of the CYPHER® Sirolimus-eluting Coronary Stent in patients experiencing a heart attack, and two head-to-head randomized clinical trials comparing the CYPHER® Stent and the Taxus Stent in difficult-to-treat patients, one of which is also in patients experiencing a heart attack. Other studies will examine the company's carotid artery stenting system in patients at high-risk of stroke and technology from Cordis Corporation's Biologics Delivery Systems Group, which will provide data about the use of adult stem cells in patients with serious heart disease.
The CYPHER® Stent: Data in Heart Attacks and Long Lesions Two randomized controlled, head-to-head studies comparing the CYPHER® Stent to the Taxus Stent in complex patient groups will be presented in the ACC's i2 Summit, the first ACC meeting specifically geared toward interventional cardiologists. One trial examines how drug-eluting stents perform in patients experiencing a heart attack, while the other provides information about their effectiveness in patients with long coronary lesions. According to guidelines by the ACC and other leading cardiology organizations, randomized clinical trials provide physicians with the highest level of evidence comparing two products.
"To date there have been eight randomized clinical trials comparing the CYPHER® Stent with the Taxus Stent," said Dr. Donohoe. "Across these trials, the CYPHER® Stent has demonstrated significant benefit in reducing late loss versus the Taxus Stent. Further, several different independent meta-analyses of these trials have demonstrated significant benefits for patients who received the CYPHER® Stent in terms of binary restenosis and target lesion revascularization compared to patients receiving the Taxus Stent. We are looking forward to the new data being presented at ACC which will add to the growing body of evidence for the CYPHER® Stent."
Key data to be presented includes:
TYPHOON Study: One-year results from this study, the first randomized multi-center clinical trial to study the safety and efficacy of the CYPHER® Stent versus bare metal stents in patients who have suffered a heart attack (acute myocardial infarction or AMI), will be presented by Christian Spaulding, M.D. during a late-breaking clinical trials presentation on Sunday, March 12 at 9:00 a.m. EST.
LONG DES-II Study: An independent, multi-center randomized controlled clinical trial comparing the CYPHER® Stent to the Taxus Stent in patients with long coronary lesions. M.K. Hong, M.D. will present this data during a late breaking clinical trial session on Sunday, March 12 at 9:00 a.m. EST.
CYPHER® Stent versus Taxus Stent in Patients with AMI: The six-month results from this independent, randomized controlled, head-to-head clinical trial investigating the benefits of treating AMI patients with either the CYPHER® Stent or the Taxus stent will be presented in a poster session by Jae-Hwan Lee, M.D. on Monday, March 13 at 10:00 a.m. EST.
Biologics Delivery Systems Group
A study featuring new technology from the Cordis Corporation's Biologics Delivery Systems Group will provide information about the use of adult stem cells in the treatment of patients with ischemic cardiomyopathy who were not candidates for conventional revascularization therapy, such as those who suffered damage to their hearts from a heart attack (myocardial infarction). Investigators used the NOGA® Cardiac Navigation System, a three-dimensional mapping system designed to precisely place biologic agents in the diseased portion of the heart muscle. Using the NOGA® System, researchers were able to inject adult stem cells directly into the heart to test the effect of a stem cell injection on a patient's cardiac function and blood flow. Mariann Gyongyosi, M.D., will present results from this 17-person study during a poster presentation on Sunday, March 12 at 1:30 p.m. EST.
Cordis Endovascular Division of Cordis Corporation: Evidenced-based Medicine for the Treatment of Vascular Disease
Theodore L. Schreiber, M.D. from Harper University Hospital in Detroit, Michigan, will present the CASES (Cordis Carotid Artery Stenting Education System) Post Marketing Study on Monday, March 13 at 8:15 am EST.
The study evaluated the 30-day major adverse event rate among high surgical-risk patients treated with carotid artery stenting (CAS) compared to patients treated with CAS and those treated with neck surgery to remove plaque buildup in the carotid artery (carotid endarterectomy) in the pivotal SAPPHIRE study. The SAPPHIRE study is the only randomized clinical trial conducted to evaluate the CAS potential in high surgical-risk patients.
The Cordis Carotid System includes two components: the PRECISE® Nitinol Self-Expanding Stent and the ANGIOGUARD(tm) Emboli Capture Guidewire. The Cordis Carotid System is intended to improve blood flow to the brain while helping to prevent debris from entering cerebral circulation. The ANGIOGUARD(tm) Emboli Capture Guidewire System is delivered beyond the lesion, where it opens into a tiny perforated basket designed to catch plaque particles dislodged during the angioplasty and stent procedure, while allowing continuous blood flow. After the stent is implanted to hold the artery open, the protective basket is closed and removed through the delivery catheter.
The CASES study involved an investigational use of the PRECISE® Nitinol Self-Expanding Stent and ANGIOGUARD(tm) XP Emboli Capture Guidewire System.
"2006 will be a busy year for Cordis' Endovascular division, as the company continues to advance treatments for peripheral artery disease, a poorly understood but common condition affecting 12 million people nationwide," said Dr. Donohoe. "We expect to initiate new clinical trials looking at the safety of the S.M.A.R.T.® Nitinol Stent in patients with superficial femoral artery (SFA) disease and roll-out products gained during the recent acquisition of Lumend, Inc. The FRONTRUNNER® XP CTO and OUTBACK® LTD(tm) Re-Entry Catheter will aid doctors nationwide as they treat complete or partial blockage of an artery, known as chronic total occlusions or CTO."
Dr. Donohoe continued, "At Cordis, we're optimizing treatments available today and committed to identifying therapies that will transform and advance care for patients suffering from vascular diseases."
More information about ACC 2006 can be found at www.acc.org .
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in developing and manufacturing interventional vascular technology. Through the company's innovation, research and development, physicians worldwide are better able to treat the 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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