Healthcare Industry News: stent thrombosis
News Release - May 15, 2006
Patient Registry to Evaluate Long-Term Safety and Efficacy of Cordis Next Generation Drug-Eluting Coronary Stents in Clinical Practicee-SELECT Registry Designated to Provide Longest Follow Up of Any DES Registry
MIAMI, May 15 (HSMN NewsFeed) -- A new global patient registry called e-SELECT designed to evaluate the real-world safety and efficacy of the CYPHER SELECT(TM) Sirolimus-eluting Coronary Stent and later generations of Cordis drug-eluting stents was initiated today by Cordis Corporation. Slated to be the only drug-eluting stent registry in the world with three year follow up, the multi-center, prospective, observational e-SELECT Registry enrolled its first patient on May 10th. Ultimately, the registry will include 30,000 patients in up to 500 centers outside the United States. The CYPHER SELECT(TM) Stent is only available in Europe, Asia Pacific, Latin America and Canada.
"The CYPHER SELECT(TM) Stent -- the first next generation drug-eluting stent -- has raised the bar for drug-eluting stents and given physicians the increased flexibility and deliverability they need to treat even complex coronary blockages," said Philip Urban, M.D., F.E.S.C., coordinating investigator for the Registry and Director of Invasive Cardiology, La Tour Hospital, Geneva, Switzerland.
Dr. Urban, who also enrolled the first patient in the registry, stated further that, "The e-SELECT Registry will be an important benchmark for physicians to observe how these patients -- and others treated with newer generations of Cordis drug-eluting stents -- fare in the near- and long-term, providing valuable insights for their own clinical practices."
The e-SELECT Registry will evaluate a variety of safety and efficacy measures including the need for repeat procedures (target lesion revascularization), major adverse cardiac events (MACE) such as heart attack and death and in-stent blood clots (stent thrombosis). Additionally, the registry population will also allow investigators to perform sub-analyses on such complex patient groups as diabetics and those with multi-vessel disease, in-stent re-blockages (restenosis) or a prior history of heart attack (myocardial infarction).
With three-years of clinical follow, the e-SELECT Registry will provide some of the most comprehensive long-term data on the safety and efficacy of a drug-eluting stent device within the field of interventional cardiology. Data collected for the registry will be uniformly reported through an Internet electronic data capture system, and an independent Clinical Event Committee made up of interventional cardiologists will meet regularly to review and adjudicate all major clinical events. Site monitoring for a selected group of participating centers is also being planned to ensure data accuracy.
Enrollment in the e-SELECT Registry will include patients treated with the CYPHER SELECT(TM) Stent in countries where the stent has been approved for commercial use. Patients treated with later generations of Cordis drug-eluting stents will also be enrolled as stents become commercially available.
"The e-SELECT Registry is the first registry to specifically document the real-world outcomes of patients treated with next generation Cordis drug-eluting stents like the CYPHER SELECT(TM) Stent," said Dennis Donohoe, M.D., Vice President, Worldwide Clinical and Regulatory Affairs, Cordis Corporation. "We are optimistic for the initial and long-term results from the e-SELECT Registry and expect it will provide important safety and efficacy trends that can be confirmed by randomized, controlled clinical trials -- the highest form of clinical evidence available."
About the CYPHER® SELECT(TM) Stent
The CYPHER SELECT(TM) Sirolimus-eluting Coronary Stent, the first commercially available next generation drug-eluting stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. The CYPHER SELECT(TM) Stent combines the same drug, polymer and delivery system found in the CYPHER® Sirolimus-eluting Coronary Stent along with added improvements in the stent design and stent delivery system. It is now available in more than 50 countries outside the United States. More information about the CYPHER SELECT(TM) Stent can be found at www.cordis.com
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.
* 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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