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. The Cypher Stent, coated with the drug Sirolimus to prevent restenosis, is inserted in blocked coronary artery. Patients, who receive this device, will need fewer repeat operations to unclog arteries which can make a real difference in the quality of their lives.

“Cordis is very pleased to bring this remarkable and innovative treatment to patients, hospitals and interventional cardiologist,” 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 represent the beginning of a new era in interventional cardiology – an era in which the combination of drugs and devices substantially improves patient outcomes. Our main objective is to make the Cypher Stent available to all patients in need of this medical technology as quickly as possible,” he said.

The Cypher Stent was first introduced in India by Cordis in June 2002, soon after it was launched in Europe, where it received the European 'CE Mark' of approval in April 2002. It is available today throughout Europe, the Middle East, Canada, Asia-Pacific and Latin America. In India alone, about 3,000 patients have benefited from the Cypher Stent.