BRIDGEWATER, N.J.--(BUSINESS WIRE)--Cordis Corporation, a worldwide leader in the development and manufacture of interventional vascular technology, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for a new, smaller version of the CYPHER® Sirolimus-eluting Coronary Stent, the world’s most studied drug-eluting stent that has been used to treat nearly 4 million people worldwide. The new 2.25 mm CYPHER® Stent is indicated for treatment of coronary blockages in small vessels, an often difficult-to-treat situation.
“Small vessels can mean big challenges, and it will be very beneficial for interventionalists and their patients to now have access to a CYPHER® Stent specifically designed for these complex cases,” said John Lasala, M.D., PhD, Professor of Medicine; Director, Interventional Cardiology and Medical Director, Cardiac Catheterization, Washington University School of Medicine in St. Louis, MO. Dr. Lasala is affiliated with Barnes-Jewish Hospital in St. Louis. “The long-term clinical benefits of the CYPHER® Stent are well documented in a broad range of patient and lesion types and this approval now allows this benefit to be applied to the treatment of small vessels."
Many types of patients have small vessel disease, including women and those with certain other medical conditions. Small coronary vessels have been associated with an increased risk of re-blockage (restenosis) after stent implantation, which requires another procedure to re-open the vessel. The smaller the artery, the more the regrowth of cells within a stent, and stent recoil narrow the lumen. This accentuates the clinical benefits of the CYPHER® Stent which is unsurpassed in limiting this process.
Today’s approval is based on the results of four studies including, in part, the clinical results of the SES-SMART trial. This trial was a randomized comparison of the 2.25 mm CYPHER® Stent to bare metal stents in the reduction of restenosis in small coronary arteries. At two years of follow up, patients receiving the CYPHER® Stent had significantly better clinical outcomes than those patients receiving a bare metal stent. In fact, use of the CYPHER® Stent led to an 82 percent reduction in restenosis compared to a bare metal stent (p<0.05) at six months.
In recent months, the FDA has approved two other drug-eluting stents for the treatment of small vessel disease, the TAXUS® Liberte® Atom™ Stent and the TAXUS® Express® Atom™ Stent, both of which elute paclitaxel. The CYPHER® Stent, which elutes sirolimus, has outperformed the TAXUS® Stent in numerous clinical trials. In the ISAR-SMART 3 trial, for example, patients treated with the CYPHER® Stent had 55% less late loss after eight months than patients receiving a TAXUS® Stent (p=0.001). Data from the RESEARCH and T-SEARCH registries showed that patients treated with the 2.25 mm CYPHER® Stent had a 65% lower incidence of death or myocardial infarction (MI) than patients treated with a 2.25 mm TAXUS® Stent (p=0.04).
“All drug-eluting stents are not created equal,” said Campbell Rogers, M.D., Chief Scientific Officer and Global Head, Research and Development, Cordis Corporation. “Based on the proven ease of use and clinical benefit of the 2.25 mm CYPHER® Stent and the strength of evidence supporting the CYPHER® Stent program more broadly, we believe this is an important new option for treating small vessel disease."
Dr. Lasala is compensated for his time as a consultant to the company and a member of the company’s scientific advisory board.
About the CYPHER® Stent
The CYPHER® Stent has been chosen by cardiologists worldwide to treat nearly four 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 200 randomized and nonrandomized studies that examine the performance of the CYPHER® Stent in a broad range of patients. A number of these studies have data now out to seven years.
For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at www.cypherstent.com.
About Cordis Corporation
For more than 50 years, Cordis Corporation, a Johnson & Johnson company, has been a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease.
More information about Cordis Corporation can be found at 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.
**The third party trademarks used herein are trademarks of their respective owners.
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“Small vessels can mean big challenges, and it will be very beneficial for interventionalists and their patients to now have access to a CYPHER® Stent specifically designed for these complex cases,” said John Lasala, M.D., PhD, Professor of Medicine; Director, Interventional Cardiology and Medical Director, Cardiac Catheterization, Washington University School of Medicine in St. Louis, MO. Dr. Lasala is affiliated with Barnes-Jewish Hospital in St. Louis. “The long-term clinical benefits of the CYPHER® Stent are well documented in a broad range of patient and lesion types and this approval now allows this benefit to be applied to the treatment of small vessels."
Many types of patients have small vessel disease, including women and those with certain other medical conditions. Small coronary vessels have been associated with an increased risk of re-blockage (restenosis) after stent implantation, which requires another procedure to re-open the vessel. The smaller the artery, the more the regrowth of cells within a stent, and stent recoil narrow the lumen. This accentuates the clinical benefits of the CYPHER® Stent which is unsurpassed in limiting this process.
Today’s approval is based on the results of four studies including, in part, the clinical results of the SES-SMART trial. This trial was a randomized comparison of the 2.25 mm CYPHER® Stent to bare metal stents in the reduction of restenosis in small coronary arteries. At two years of follow up, patients receiving the CYPHER® Stent had significantly better clinical outcomes than those patients receiving a bare metal stent. In fact, use of the CYPHER® Stent led to an 82 percent reduction in restenosis compared to a bare metal stent (p<0.05) at six months.
In recent months, the FDA has approved two other drug-eluting stents for the treatment of small vessel disease, the TAXUS® Liberte® Atom™ Stent and the TAXUS® Express® Atom™ Stent, both of which elute paclitaxel. The CYPHER® Stent, which elutes sirolimus, has outperformed the TAXUS® Stent in numerous clinical trials. In the ISAR-SMART 3 trial, for example, patients treated with the CYPHER® Stent had 55% less late loss after eight months than patients receiving a TAXUS® Stent (p=0.001). Data from the RESEARCH and T-SEARCH registries showed that patients treated with the 2.25 mm CYPHER® Stent had a 65% lower incidence of death or myocardial infarction (MI) than patients treated with a 2.25 mm TAXUS® Stent (p=0.04).
“All drug-eluting stents are not created equal,” said Campbell Rogers, M.D., Chief Scientific Officer and Global Head, Research and Development, Cordis Corporation. “Based on the proven ease of use and clinical benefit of the 2.25 mm CYPHER® Stent and the strength of evidence supporting the CYPHER® Stent program more broadly, we believe this is an important new option for treating small vessel disease."
Dr. Lasala is compensated for his time as a consultant to the company and a member of the company’s scientific advisory board.
About the CYPHER® Stent
The CYPHER® Stent has been chosen by cardiologists worldwide to treat nearly four 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 200 randomized and nonrandomized studies that examine the performance of the CYPHER® Stent in a broad range of patients. A number of these studies have data now out to seven years.
For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at www.cypherstent.com.
About Cordis Corporation
For more than 50 years, Cordis Corporation, a Johnson & Johnson company, has been a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease.
More information about Cordis Corporation can be found at 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.
**The third party trademarks used herein are trademarks of their respective owners.
Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6054856&lang=en
