Healthcare Industry News:  Vascular Stent 

Devices Interventional Cardiology FDA

 News Release - May 11, 2006

Cordis Corporation Submits Pre-Market Approval Submission for Reblockage in Coronary Stent

MIAMI, May 11 (HSMN NewsFeed) -- Cordis Corporation today announced that it has filed a pre-market approval submission (PMA) with the U.S. Food and Drug Administration (FDA) for an in-stent restenosis indication for the CYPHER® Sirolimus-eluting Coronary Stent. In-stent restenosis is a reblockage of the coronary artery and a potential complication of stenting.

The foundation for the PMA was data from the SISR Trial (A Randomized Trial Comparing Sirolimus-Eluting Stent with Vascular Brachytherapy for the Treatment of In-Stent Restenosis Within Bare Metal Stents), a multi-center, randomized study of 384 patients from 26 academic and community health centers in the United States.

In that trial, which was sponsored by Cordis Corporation and appeared recently in the prestigious Journal of the American Medical Association (March 12th edition), patients who received the CYPHER® Stent had a significantly lower incidence of target vessel failure defined as cardiac death, heart attack (myocardial infarction), or the need to re-open the artery (target vessel revascularization), compared with patients who received radiation from within a vessel (brachytherapy). In this trial, the CYPHER® Stent was compared to brachytherapy for the treatment of blockage (restenosis) in patients who already have a bare metal stent.

"We are pleased to file this application with the FDA," said Dennis Donohoe, M.D., Vice President, Worldwide Clinical and Regulatory Affairs, Cordis Corporation. "We look forward to working with the Agency through this review process."

About the CYPHER® Stent

The CYPHER® Stent has been chosen by cardiologists worldwide to treat more than two 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 40 Cordis studies, apart from many important independent clinical trials that have been performed, 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 longest-term clinical follow-up of any drug-eluting stent. The CYPHER SELECT(TM) Sirolimus-eluting Coronary Stent, the first next generation drug-eluting stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. More information about the CYPHER® Stent can be found at

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.

Source: Cordis

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