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Miami, FL. US | Jan 23, 2006 | The U.S. Food and Drug Administration (FDA) approved revised instructions for use (IFU) for the CYPHER® Sirolimus-eluting Coronary Stent. The labeling now reflects FDA's review of clinical trial data that suggests there is no increased risk of myocardial infarction (heart attack) with the use of overlapping CYPHER® Stents in comparison to bare metal
stents. This labeling change is based on a retrospective analysis of several clinical studies of overlapping CYPHER® Stents examining more than 900 patients.
The CYPHER® Stent is the only drug-eluting stent with this new label.
Overlapping stents are most often used in patients with complex coronary artery disease in which the blockage is too long for a single stent. Today, approximately 25 percent of stenting procedures involve the use of overlapping coronary stents.
"We are pleased that the FDA has approved this change in the CYPHER® Stent labeling," said Dennis Donohoe, M.D., worldwide vice president of Clinical Research and Regulatory Affairs, Cordis Corporation. "This new label provides cardiologists with additional information suggesting that there is no increase in risk of heart attack when overlapping stents are used. This new information will be welcome news to physicians and their patients."
The use of overlapping CYPHER® Stents has been evaluated in numerous prospective randomized controlled studies, which are the highest form of clinical evidence to evaluate the safety and efficacy of a medical device. The trials and registries include SIRIUS (SIRolImUS-coated BX VELOCITY® Balloon Expandable Stent in the treatment of patients with de novo coronary artery lesions), E-SIRIUS (European version of SIRIUS), C-SIRIUS (Canadian version of SIRIUS), DIRECT (DIRECT stenting using the Sirolimus-eluting BX VELOCITY® Stent) and SVELTE (Study in Patients with De Novo Coronary Artery Lesions in Small Vessels Treated with the CYPHER® Stent).
The label retains its current precaution statements for multiple CYPHER® Stents. The revised labeling can be found at www.cypherusa.com.
About the CYPHER® Stent
The CYPHER® Stent has been chosen by cardiologists worldwide to treat more than 1.5 million patients with coronary artery disease. The safety and efficacy of the device is supported by a robust clinical trial program that includes more than 40 studies, inclusive of independent clinical trials, that examine the performance of the CYPHER® Stent in a broad range of patients. Developed and manufactured by Cordis Corporation, the CYPHER® Stent is currently available in more than 80 countries and has the longest-term clinical follow-up of any drug-eluting stent. The CYPHER® SELECT™ 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® 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®. Rapamune® is a trademark of Wyeth Pharmaceuticals.
Source: Johnson & Johnson |
