CORDIS DEVELOPS CYPHER SIROLIMUS-ELUTING CORONARY STENT.

Johnson & Johnson, New Brunswick, N.J., has reported that its 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 U.S. since Food and Drug Administration (FDA) approval in April 2003.

"In the nine months since we introduced the CYPHER Stent in the U.S., the product's use has surpassed our expectations," said Guy J. Lebeau, M.D., Johnson & Johnson Company Group Chairman with management responsibility for Cordis Corporation's worldwide operations. "Today nearly 60% of U.S. 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 U.S. a year later, the new stent is the first and only commercially available drug-device combination in the U.S. 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, U.S. president, Cordis Cardiology, a division of Cordis Corporation.

A New Era in Interventional Cardiology 

Paul Teirstein, M.D., Director of Interventional Cardiology, Scripps Clinic, LaJolla, CA, whose institution was one of 53 investigative sites participating in the CYPHER Stent U.S. clinical trials, has seen outstanding results in the more than 1,000 patients he has treated in the U.S. during the last nine months.

"We are seeing a significant migration from bare metal stents to drug-eluting stents in the interventional cardiology arena. The CYPHER Stent has become the stent of choice among interventional cardiologists because of the improved clinical and safety outcomes. In the patients that I have treated, the results are exceptional nine months out."

Due to the presence of a drug and polymer, it is important to look at long-term clinical and real-world outcomes when selecting a drug-eluting stent.

"As physicians, we want to utilize a drug-eluting stent with an excellent safety profile and sustained outcomes over time," added Dr. Teirstein. "The efficacy, safety and deliverability of the CYPHER Stent are supported by a volume of clinical evidence that is unprecedented in the device world."

For patients like 76-year-old Helen Rehak who received two CYPHER Stents in 2002 during a clinical trial that was conducted prior to FDA approval, the chance of avoiding a repeat procedure is far greater with the CYPHER Stent.

"In my 25 years of battling heart disease, I have undergone three open heart surgeries, intravascular brachytherapy and multiple bare metal stent procedures," said Rehak. "For the first time, I am optimistic about not having to return to my doctor for another procedure. I recently had a clinical follow-up and my arteries are as clear as the day my cardiologist placed the CYPHER Stents."

Continued Safety and Efficacy

In the Dec. 22 issue of Circulation: Journal of the American Heart Association, clinical results from the RESEARCH Registry, a recent study conducted in The Netherlands by lead investigator Patrick W. Serruys, MD, demonstrated the performance of the CYPHER Stent in treating patients with complex coronary artery lesions. The final results showed that in "real world" clinical practice, use of the CYPHER Stent appears to be safe and more effective than bare stents in reducing the need for repeat procedures and major adverse coronary events.

Next Generation Drug-eluting Stents:

Cordis Cardiology is already at work in the development of next generation CYPHER Stents, which will be enhanced to offer physicians better deliverability and product features. The company already launched its next generation CYPHER Stent outside of the U.S. in the third quarter of 2003 and plans to do the same in the United States sometime in 2004 or 2005.

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.jnj.com.