CYPHER SIROLIMUS-ELUTING CORONARY STENT ON APPROVAL TRACK.
Cordis Corporation, Miami, a Johnson & Johnson company, has announced that its CYPHER See cipher. Sirolimus-eluting Coronary Stent sirolimus-eluting coronary stent Cardiology A coronary artery stent graft which has sirolimus, an imunosuppressive and antimitotic agent incorporated into its matrix, which significantly ↓ restenosis of stents.
See RAVEL. 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 coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. ," 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 United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , in the number of coronary artery coronary artery
1. An artery with origin in the right aortic sinus; with distribution to the right side of the heart in the coronary sulcus, and with branches to the right atrium and ventricle, including the atrioventricular branches and procedures performed annually.
Each year, approximately 166,000 angioplasties are performed in Japan, and 70% of them undergo treatment with conventional bare metal 1. bare metal - New computer hardware, unadorned with such snares and delusions as an operating system, an HLL, or even assembler. Commonly used in the phrase "programming on the bare metal", which refers to the arduous work of bit bashing needed to create these basic tools stents.
The CYPHER Stent, the world's first drug-eluting coronary stent coronary stent Intracoronary stent Cardiology An expandable tubular device which can be inserted percutaneously, and left within a coronary artery lumen to maintain its patency Pros Clinical and angiographic outcomes are better with intracoronary artery 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 scar tissue
Dense, fibrous connective tissue that forms over a healed wound or cut. growth, a major cause of reblockage. Sirolimus is a cytostatic cytostatic /cy·to·stat·ic/ (sit?ah-stat´ik)
1. suppressing the growth and multiplication of cells.
2. an agent that so acts.
1. 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.