Johnson & Johnson reported that the Cypher Sirolimus-eluting coronary stent, a new technology development by wholly owned subsidiary, Cordis Corporation, is the coronary "stent of choice" in the United States. Nearly 500,000 patients have been treated with the Cypher Stent in more than 80 countries around the world, with more than 350,000 of them treated in the US since Food and Drug Administration (FDA) approval in April 2003.
"In the nine months since we introduced the Cypher stent in the US, the product's use has surpassed our expectations," said Guy Lebeau, MD, Johnson & Johnson company group chairman with management responsibility for Cordis Corporation's worldwide operations. "Today nearly 60 per cent of US patients receiving a coronary stent benefit from the breakthrough technology of the Cypher stent and usage is also increasing in other parts of the world. The Cypher stent continues to demonstrate excellent clinical results and safety in a broad range of patients that now have a better chance of avoiding a repeat procedure," he added.
Approved for marketing in Europe in April 2002 and in the US a year later, the new stent is the first and only commercially available drug-device combination in the US to significantly reduce the likelihood of patients requiring treatment for restenosis in the coronary arteries. In the nine months since FDA approval, the Cypher stent has continued to deliver on its clinical promise with real-world patient data adding to the already growing body of clinical evidence supporting the safety and efficacy of the device.
Last month, the American Heart Association named the Cypher stent one of the top 10 medical advancements of 2003, citing the strong real-world patient data that demonstrates the drug-eluting stent is living up to its promise.
"The data on physician usage of the Cypher stent since marketing approval have reinforced what we learned in our clinical trials - that our drug-eluting stent performs exceptionally well in reducing restenosis (vessel reblockage)," said Rick Anderson, US president, Cordis Cardiology, a division of Cordis Corporation.