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Cypher® Sirolimus-Eluting Coronary Stent Receives FDA Approval for MRI Scans
24 Apr 2005

Immediately Following Implantation Cypher® Stent Patients Benefit From Immediate Access to Important MRI Tests, Diagnostics -

Cordis Corporation, a Johnson & Johnson company, today announced that the U.S. Food and Drug Administration (FDA) has approved a condition of use for the Cypher® Sirolimus-eluting Coronary Stent, allowing patients receiving the stent to immediately undergo Magnetic Resonance Imaging (MRI) following implantation. Approval was granted after laboratory studies demonstrated the Cypher® Stent is MRI-safe.

"With the FDA approval, cardiologists and their patients receiving a Cypher® Stent can now benefit from important MRI tests and diagnostics immediately following the procedure, further enhancing the overall level and quality of health care for stent patients," said Dennis Donohoe, M.D., worldwide vice president of Regulatory and Clinical Affairs for Cordis Corporation.

MRI is an important tool for imaging and diagnosing a variety of medical conditions. Due to the use of intense magnetic fields during MRI testing, laboratory studies needed to show that implanted medical devices that contain stainless steel metal, such as stents, are safe and not subject to potential migration and heating. The laboratory studies on the Cypher® Stent provided the evidence needed for this condition of use. Patients no longer have to wait two months after a procedure with the Cypher® Stent before undergoing an MRI test.

About the Cypher® Stent

Developed and manufactured by Cordis Corporation, the Cypher® Stent is currently available in more than 80 countries and has been used by doctors to treat more than one million patients worldwide. With more than 40 clinical trials conducted or in progress worldwide, the Cypher® Stent remains the most studied drug-eluting stent today with the largest body of clinical evidence demonstrating the long-term safety and efficacy of its drug and polymer. In clinical trials, the Cypher® Stent has been shown to reduce reblockage in the arteries by more than 90 percent over a conventional bare metal stent. More information about the Cypher® Stent can be found at http://www.Cypherusa.com.

About Cordis Corporation

Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in developing and manufacturing interventional vascular technology. Through research, development and innovation, physicians worldwide are better able to treat the millions of patients who suffer from vascular disease. For more information about Cordis Corporation, please visit http://www.cordis.com.

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®. Rapamune® is a trademark of Wyeth Pharmaceuticals.

http://www.jnj.com/news