Cordis Corporation, a Johnson & Johnson company, has received approval from the U.S. Food and Drug Administration (FDA) to market its Cypher Sirolimus-eluting Coronary Stent, making it the first U.S.-approved combination drug device intended to help reduce restenosis (reblockage) of a treated coronary artery. Restenosis is one of the greatest challenges in long-term patient treatment in interventional cardiology.

"Cordis is very pleased to bring this remarkable and innovative treatment to patients, hospitals and interventional cardiologists," said Johnson & Johnson Company Group Chairman Robert Croce, who has worldwide management responsibility for Cordis Corporation. "Clinical evidence and experience with more than 50,000 patients treated to date in nearly 60 countries suggests the Cypher Stent represents the beginning of a new era in interventional cardiology - an era in which the combination of drugs and devices substantially improves patient outcomes."

Jeffrey W. Moses, of Lenox Hill Hospital, New York, a principal investigator in the U.S. clinical trials for the new device, said, "The Cypher Stent clinical trials set a new standard in coronary artery stent investigation. No other stent in this category has been studied so extensively in such a wide range of high-risk patients with difficult-to-treat lesions. Clinical evidence is clear that cardiologists can use this new stent with confidence."

Croce explained that the FDA approved the Cypher Stent under an expedited review for use in native coronary arteries with reference diameters of 2.5 mm to 3.5 mm and lengths in 8, 13, 18, 23, 28 and 33 mm. This covers the majority of stent cases performed today.

The Cypher Stent was first introduced by Cordis Corporation in April 2002, and is now available throughout Europe, the Middle East, Canada, Asia-Pacific and Latin America.