Healthcare Industry News:  drug-eluting stent 

Devices Interventional Cardiology Regulatory

 News Release - June 22, 2006

Cordis Corporation's Third-Generation Coronary Stent Approved for Use in Europe

CYPHER SELECT(TM) PLUS Combines Excellent, Long-term Clinical Performance with Exceptional Deliverability to Treat Blockages in Coronary Arteries

MIAMI, June 22 (HSMN NewsFeed) -- Cordis Corporation, the world leader in the drug-eluting stent market, announced today that its CYPHER SELECT(TM) PLUS has become the first third-generation drug-eluting stent to receive CE (Communite European) Mark approval. The company will begin launching the product in Europe in September with full market launch by the end of the year.

Featuring an enhanced stent delivery system, CYPHER SELECT(TM) PLUS offers exceptional deliverability, as well as the excellent, long-term clinical performance for which the CYPHER® Stent is widely known.

"A broad range of clinical studies has demonstrated that the CYPHER® Stent is an effective and safe treatment for coronary artery disease," said Philip Urban, M.D., F.E.S.C., Director of Invasive Cardiology, La Tour Hospital in Geneva, Switzerland, and the coordinating investigator of e-SELECT Registry, a global registry designed to assess the performance of the CYPHER SELECT(TM) family of stents in daily clinical practice. "CYPHER SELECT(TM) PLUS builds upon that tradition of excellence by featuring enhancements that ease the delivery of the stent to the site of a lesion."

In addition to its flexible stent design and short tip, CYPHER SELECT(TM) PLUS features the CYPH2ONIC(TM) hydrophilic coating technology, an innovative coating technology that is significantly more lubricious than previous CYPHER® Stent products, greatly increasing a physician's ability to successfully navigate challenging coronary arteries.

"CYPHER SELECT(TM) PLUS showcases Cordis' commitment to the treatment of vascular disease," said Dennis Donohoe, M.D., Vice President, Worldwide Clinical and Regulatory Affairs, Cordis Corporation. "With CYPHER SELECT(TM) PLUS, physicians will experience unprecedented ease in the delivery of a highly effective stent with an excellent, long-term safety profile for the treatment of coronary artery disease."

With CE mark now secured, the company is aggressively building its manufacturing capacity for the CYPHER SELECT(TM) PLUS launch. The company is committed to ensure that physicians have ready access to the product as it becomes available in various countries outside the U.S.

"As the world's leading developer and manufacturer of drug-eluting stents, we are pleased with the approval of the CYPHER SELECT(TM) PLUS which marks yet another important step in our goal to defeat cardiovascular disease," said Rick Anderson, Company Group Chairman, Johnson & Johnson and Worldwide Franchise Chairman, Cordis Corporation. "Through innovation, education and clinical evidence, the Cordis franchise -- Cordis Cardiology, Cordis Endovascular, Cordis Neurovascular, Biologics Delivery Systems Group -- and Biosense Webster, continues to define excellence in bringing breakthrough products to market. Collectively, our companies represent leadership in the cardiac and vascular fields."

In 2004, Cordis introduced the first second-generation drug-eluting stent -- CYPHER SELECT(TM) -- outside the United States.

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 studies, inclusive of independent clinical trials, 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 first next generation drug- eluting stent, the CYPHER SELECT(TM) Sirolimus-eluting Coronary Stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. More information about the CYPHER® Stent can be found at http://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.


Source: Cordis

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