MIAMI, April 26 /PRNewswire/ -- Two million patients have received the CYPHER(R) Sirolimus-eluting Coronary Stent since its market introduction in Europe in April 2002, a first-time milestone for any company in the drug- eluting stent industry. The CYPHER(R) Stent is the world leading drug-eluting stent for the treatment of coronary artery disease and helped redefine innovation in interventional cardiology.
“The CYPHER(R) Stent represents an innovative advance in science that has significantly changed the practice of interventional cardiology,” said Professor J. Eduardo Sousa, MD, PhD, Institute Dante Pazzanese of Cardiology, Sao Paulo, Brazil. “It is a safe and effective treatment option for a wide range of patients and continues to be the top choice for interventional cardiologists globally.” Dr. Sousa was the first physician in the world to implant a CYPHER(R) Stent.
Troy Gramling is just one of the two million patients who have benefited from receiving a CYPHER(R) Stent. After a series of tests revealed that Gramling, a pastor at Flamingo Road Church in Ft. Lauderdale, Florida, was suffering from coronary artery disease in 2006, the then 38 year-old, received two CYPHER(R) Stents.
“When an angiogram showed that I had three blockages, I was rushed to a local hospital’s cardiac catheterization laboratory,” said Gramling. “I was relieved to know that the hospital used the CYPHER(R) Stent and that I would not need to have bypass surgery, which can take months to recover from.” Just days after the procedure, Gramling was back at work, playing with his children and participating in sports.
The CYPHER(R) Stent combines a coronary stent platform with a unique drug- delivery system that works to keep arteries propped open after a cardiac procedure while releasing small amounts of a medication to prevent scar tissue from forming inside the vessel. Physicians have noted that the two million patient milestone for the CYPHER(R) Stent is due to the broad range of patients the device can successfully and safely treat.
“The increasing body of clinical evidence supporting the use of the CYPHER(R) Stent, even in complex and difficult-to-treat patients, is unprecedented and has helped establish the CYPHER(R) Stent as the leading drug-eluting stent used by interventional cardiologists globally,” said Dennis Donohoe, M.D., Vice President, Worldwide Regulatory and Clinical Affairs, Cordis Corporation. “Technologies like the CYPHER(R) Stent are improving the standard of care for patients everyday.”
PMA Submission for 2.25 mm CYPHER(R) Stent
Cordis Corporation also announced today it has submitted a pre-market approval application to the U.S. Food and Drug Administration for approval of a 2.25 mm version of the CYPHER(R) Stent. The additional size is designed to provide physicians with more options for treating patients with coronary artery disease who are candidates for a drug-eluting stent like the CYPHER(R) Stent.
“The submission of this application to the FDA demonstrates Cordis’ commitment to ensuring physicians have the tools they need to treat their patients,” said Dennis Donohoe, M.D., Vice President, Worldwide Clinical and Regulatory Affairs, Cordis Corporation. “We will continue to work closely with the FDA through this approval process.”
About the CYPHER(R) Stent
The CYPHER(R) Stent has been chosen by cardiologists worldwide to treat more than two 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 Cordis studies, apart from many important independent clinical trials that have been performed, that examine the performance of the CYPHER(R) Stent in a broad range of patients. Developed and manufactured by Cordis Corporation, the CYPHER(R) Stent is currently available in more than 80 countries and has the longest-term clinical follow-up of any drug-eluting stent. The first next generation drug-eluting stent, the CYPHER SELECT(TM) Sirolimus-eluting Coronary Stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. More information about the CYPHER(R) 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 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.
Cordis Corporation
CONTACT: Christopher Allman of Cordis Cardiology, Office -+1-786-313-2303, Mobile - +1-306-586-6024, callman1@crdus.jnj.com; or ToddRingler of Edelman, Office - +1-212-704-4572, Mobile - +1-617-872-1235,todd.ringler@edelman.com
Web site: http://www.cordis.com/