MIAMI, May 17 /PRNewswire/ -- Cordis Corporation today announced that it has filed a pre-market approval supplement (PMA) with the U.S. Food and Drug Administration (FDA) to include language in the instructions for use (IFU) about direct stenting of the CYPHER(R) Sirolimus-eluting Coronary Stent. Direct stenting is the placement of a stent without balloon pre-dilatation.
The foundation for the PMA is data from the DIRECT Stent Trial, a multi-center, prospective, non-randomized study of 225 patients. The trial compared the results of direct stenting to those obtained using conventional balloon pre-dilatation from the previously reported SIRIUS trial.
“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(R) Stent
The CYPHER(R) 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(R) Stent in a broad range of patients. Developed and manufactured by Cordis Corporation, the CYPHER(R) 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(R) Stent can be found at www.cypherusa.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(R). Rapamune is a trademark of Wyeth Pharmaceuticals.
Cordis Corporation
CONTACT: Christopher Allman, Cordis Cardiology, +1-786-313-2303, Mobile:+1-306-586-6024, callman1@crdus.jnj.com; Todd Ringler, Edelman,+1-212-704-4572, Mobile: +1-617-872-1235, todd.ringler@edelman.com
Web site: http://www.cypherusa.com/
