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CYPHER SIROLIMUS-ELUTING CORONARY STENT ON APPROVAL TRACK.

Cordis Corporation, Miami, a Johnson & Johnson company, has announced that its CYPHER Sirolimus-eluting Coronary Stent has passed a critical milestone in the Japanese regulatory process. The CYPHER Stent received the endorsement of the Bukai, a subcommittee of the Japanese Ministry of Health, Labor and Welfare, leaving one final meeting, with the Bunka-kai, in order to receive approval. CYPHER Stent approval in Japan is expected in the second quarter, 2004. Typically, an endorsement by the Bukai is a prelude to final approval.

"We are looking forward to making this important technology available to the millions of people in Japan who suffer with coronary artery disease," said Guy J. Lebeau, M.D., company group chairman with management responsibility for Cordis Corporation's worldwide operations. Dr. Lebeau noted that Japan ranks second, behind the United States, in the number of coronary artery procedures performed annually.

Each year, approximately 166,000 angioplasties are performed in Japan, and 70% of them undergo treatment with conventional bare metal stents.

The CYPHER Stent, the world's first drug-eluting coronary stent, represents a new generation of coronary stent technology. The stent is coated in a polymer that gradually releases the drug sirolimus into the vessel wall to stop scar tissue growth, a major cause of reblockage. Sirolimus is a cytostatic agent, meaning it stops cells from dividing without destroying them.

"In clinical trials, the CYPHER(R) Stent has been shown to reduce arterial reblockage by more than 90 percent over a conventional bare metal stent," said Dr. Lebeau. "Less than 5% of patients treated with the CYPHER Stent have returned for repeat procedures in the treated vessels compared with 20-30% of patients who receive a bare metal stent."

The CYPHER Stent, which received U.S. approval for marketing in April 2003, is now available in 80 countries and has been used to treat more patients than any other drug-eluting stent -- greater than 550,000 patients worldwide. The CYPHER Stent currently has investigational status in Japan. With clinical follow-up out to four years, CYPHER -- the only drug-eluting stent using the drug, sirolimus, has the longest-term data available of any drug-eluting stent.

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 in the interventional cardiovascular field. Today, more than 7,000 Cordis Corporation employees worldwide share a strong commitment to continue the company's groundbreaking work in the fight against vascular disease.

For more information, call 786/313-2545 or visit http://www.cordis.com.
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Publication:Biotech Equipment Update
Geographic Code:1USA
Date:May 1, 2004
Words:440
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