News Release

New study results suggest better outcomes with the CYPHER® Stent than brachytherapy

SISR nine-month outcomes presented at TCT 2005

Peer-Reviewed Publication

Edelman Public Relations, New York

WASHINGTON, D.C. - (October 17, 2005) - Results from the SISR trial, a multi-center, randomized study of the CYPHER(r) Sirolimus-eluting Coronary Stent versus radiation from within a vessel (brachytherapy) in patients with bare-metal in-stent reblockage (restenosis), were presented today at the Transcatheter Cardiovascular Therapeutics (TCT).

2005) Scientific Symposium. The study showed that patients who received the CYPHER(r) Stent had a significantly lower incidence of target vessel failure (TVF) at nine months post-procedure compared with patients who received brachytherapy. The SISR trial was sponsored by Cordis Corporation, a Johnson & Johnson company.

"The efficacy and safety results from this study were significantly better in the drug-eluting stent arm of the study," said Principal Investigator David R. Holmes, Jr., M.D., Professor of Medicine at the Mayo Clinic College of Medicine. "The CYPHER(r) Stent has shown excellent results in complex patient cases and this is another example of a strong clinical performance in a category that has challenged physicians for years."

A large, multicenter, randomized study involving 384 patients, the Sirolimus-eluting CYPHER(r) Stent Versus Intravascular Brachytherapy In the Treatment of Patients with In-Stent Restenotic Coronary Artery Lesions, or SISR trial, showed the superior safety profile of the

CYPHER(r) Stent compared to intravascular brachytherapy in complex patients. The primary endpoint of the study was the incidence of TVF, defined as cardiac death, heart attack (myocardial infarction), or the need to re-open the artery (target vessel revascularization, or TVR) at nine months.

Nine-Month Events

  • CYPHER(r) Stent (n=259)
  • Brachytherapy (n=125)
  • P value
Target vessel failure
  • 12.4 %
  • 21.8 %
  • 0.023
MACE
  • 10.0 %
  • 19.2 %
  • 0.015
Target lesion revascularization
  • 8.5 %
  • 19.2 %
  • 0.004
The nine-month results of the SISR data were highlighted today in a late-breaking session at TCT, highlighted by Dr. Holmes and moderated by Martin B. Leon, M.D., and Patrick W. Serruys, M.D. The results revealed that the CYPHER(r) Stent resulted in fewer Major Adverse Cardiac Events (MACE), including death, heart attack and stroke at nine-month follow-up (10.0 percent compared to 19.2 percent; p=0.015) by significantly decreasing the need for TLR procedures (8.5 percent versus 19.2 percent; p=0.004).

"The results from the data presented today at TCT continue to build on our body of evidence for treating complex patients," said Brian Firth, M.D., Ph.D., Vice President of Medical Affairs and Health Economics, Cordis Corporation. "It is necessary to provide a treatment option that is safe and effective and the CYPHER Stent continues to demonstrate excellent outcomes in clinical trials and in the real world."

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Information on all of the CYPHER(r) Stent-related studies being presented at TCT 2005 can be found at www.tct2005.com .

About the CYPHER(r) Stent
The CYPHER(r) Stent has been chosen by cardiologists worldwide to treat more than 1.5 million patients with coronary artery disease. It is supported by a robust clinical trial program, which includes more than 40 studies examining its performance in vessels of varying complexity.

Developed and manufactured by Cordis Corporation, the CYPHER(r) Stent is currently available in 80 countries. CYPHER SELECT(tm) Sirolimus-eluting Coronary Stent, which is the first next generation drug-eluting stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003.

More information about the CYPHER(r) Stent can be found at www.cypherusa.com .

About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in developing and manufacturing interventional vascular technology.

Through the company's innovation, research and development, physicians worldwide are better able to treat the millions of patients who suffer from vascular disease.

*Cordis Corporation has entered into an exclusive worldwide license with Wyeth for the localized delivery of sirolimus in certain fields of use, including delivery via vascular stenting. Sirolimus, the active drug released for the stent, is marketed by Wyeth Pharmaceuticals, a division of Wyeth, under the name Rapamune(r). Rapamune is a trademark of Wyeth Pharmaceuticals.


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