MIAMI, Mar 31, 2004 /PRNewswire-FirstCall via COMTEX/ -- Cordis Corporation, a Johnson & Johnson company, reported today it has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market its CYPHER(R) Sirolimus-eluting Coronary Stent in Japan.
CYPHER(R) Stent distribution in Japan is expected to begin mid-year, coincident with government approval of reimbursement. Japan is the world's second largest interventional cardiology market with approximately 166,000 angioplasties performed annually, 70% of which involve stent placement.
"The CYPHER Stent will provide Japanese interventional cardiologists with an important new tool to safely treat coronary artery disease," said Akira Matsumoto, President, Johnson & Johnson K.K. "We will be working closely with Japanese physicians to optimize patient outcomes with the CYPHER Stent."
The CYPHER Stent is Japan's first approved drug-device combination to significantly reduce the incidence of restenosis (reblockage) of a treated coronary artery -- one of the greatest challenges in long-term management of patients with heart disease. The CYPHER Stent has been shown to reduce restenosis by 90% compared with a conventional bare metal stent.
"Cordis is very pleased to bring this breakthrough technology to physicians and patients in Japan," said Guy Lebeau, M.D., a Johnson & Johnson Company Group Chairman who has worldwide management responsibility for Cordis Corporation. "Clinical evidence and worldwide experience with more than 600,000 patients treated to date demonstrates the safety and effectiveness of the CYPHER(R) Stent and its ability to dramatically improve the lives of patients."
The World's Most Studied Drug-eluting Stent
"The CYPHER Stent is the only drug-eluting coronary artery stent whose performance is supported by four large-scale, randomized, double-blind, controlled clinical trials involving approximately 1,800 patients," said Jeffrey W. Moses, M.D., of Lenox Hill Hospital, New York, a principal investigator in the U.S. clinical trial, SIRIUS, which was also used for the Japanese regulatory submission for approval. "No other stent in this category has been studied as extensively in clinical trials and registries across such a broad range of patients, including some high-risk patients with difficult- to-treat lesions."
Data from the three-year follow-up on the European RAVEL trial and the four-year follow-up on the First-in-Man trials were presented at the American College of Cardiology's 53rd Scientific Session earlier this month. CYPHER Stent data showed sustained reduction in the incidence of reblockage compared to a conventional bare metal stent, with a 94% chance that patients can avoid retreatment.
About the CYPHER Stent
One of the most significant advancements in the treatment of heart disease in the past decade, the CYPHER Stent offers an important advantage over conventional bare metal stents. The CYPHER Stent props the vessel open while its polymer coating gradually releases the drug sirolimus* into the vessel lining to prevent scar tissue growth, a frequent reaction that leads to reblockage following current treatment procedures.
The CYPHER(R) Stent was introduced by Cordis Corporation in April 2002 in Europe and in April 2003 in the United States. It is now available in 80 countries throughout Europe, the Middle East, Canada, Asia-Pacific and Latin America.
About Cordis Corporation
For more than 40 years, Cordis Corporation, a Johnson & Johnson company, has pioneered less-invasive treatments for vascular disease. Technological innovation and a deep understanding of the medical marketplace and the needs of patients have made Cordis the world's leading developer and manufacturer of breakthrough products for interventional medicine, minimally invasive computer-based imaging, and electrophysiology. Today, 7,000 Cordis employees worldwide share a strong commitment to continue the company's groundbreaking work in the fight against vascular disease.
For additional information on the CYPHER Stent, visit www.CYPHERUSA.com or call 1-800-781-0282.
* Cordis 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 from the stent, is marketed by Wyeth Pharmaceuticals, a division of Wyeth, under the name Rapamune(R). Rapamune is a trademark of Wyeth Pharmaceuticals.
SOURCE Cordis Corporation
Press, Martin E. Schildhouse, Cordis Corporation, +1-786-313-2545, or Cell, +1-305-606-3577; Jeffrey J. Leebaw, +1-732-524-3350, or Cell, +1-908-227-7231, or Investor Relations, Helen E. Short, +1-732-524-6491, Stan Panasewicz, +1-732-524-2524, all of Johnson & Johnson /Company News On-Call: http://www.prnewswire.com/comp/467347.html
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