New Clinical Data for Cypher® Sirolimus-Eluting Coronary Stent & Innovative Cordis Technologies to Be Showcased at World Congress of Cardiology 2006
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MIAMI, Aug. 29-- Cordis Corporation and some of its European affiliates will report on new clinical study data, introduce new products for the treatment of cardiovascular disease, host a drug-eluting stent educational symposium and promote the global Cordis® Cardiac & Vascular Institute(SM) at the upcoming World Congress of Cardiology (WCC) 2006, taking place in Barcelona, Spain, from Sept. 2-6. WCC 2006 is a joint meeting of the European Society of Cardiology and the World Heart Federation.
"Cordis' leadership in addressing cardiac and vascular diseases will be evident at WCC 2006," said Dennis Donohoe, M.D., Vice President, Worldwide Regulatory and Clinical Affairs, Cordis Corporation. "Cordis has maintained a reputation of excellence through clinical evidence, innovation and education for more than 40 years, and during the conference, we intend to highlight how we continue to lead in each area."
Long-term Clinical Evidence
Clinical data presented at WCC 2006 will add to the robust body of evidence for the long-term safety and efficacy of the CYPHER® Sirolimus- eluting Coronary Stent. Among the Cordis-sponsored results to be unveiled are:
REALITY Study: Two-year data from the randomized, multi-center clinical trial comparing the safety and efficacy profiles of the CYPHER® Stent and the Taxus Stent will be presented by Marie-Claude Morice, M.D., Institut Cardiovasculaire Paris Sud, France, on Sept. 5 at 2 p.m. (CEST). The study investigators have been tracking major adverse cardiac events, also known as MACE, including heart attacks and blood clots, with both stents.
E-SIRIUS Study: Four-year results from one of the longest-running randomized, double-blind studies comparing the outcomes of the CYPHER(R) Stent versus bare-metal stents specifically in the European population will be presented by Joachim Schofer, M.D., Hamburg University, Germany on Sept. 6 at 8:45 a.m. (CEST). This study aims to evaluate whether the previously reported benefits of using the CYPHER® Stent over bare-metal stents to treat patients with heart disease are durable.
"Physicians want to know that every stent they implant provides sustained benefits for their patients," said Dr. Donohoe. "The clinical data demonstrate that the CYPHER® Stent remains safe and effective for a wide range of patients in the long-term, including those most likely to experience a re- blockage. We expect that the new data presented at WCC 2006 will continue to add to our understanding of the long-term safety and efficacy of the CYPHER® Stent."
Other Cordis-sponsored studies to be presented at WCC 2006 include five- year results of the RAVEL Study, the first randomized study on a drug-eluting stent; results from the use of the CYPHER® Stent in unprotected left main coronary arteries in an European retrospective registry and the e-CYPHER Registry; results from the treatment of chronic total occlusion with the CYPHER® Stent in the e-CYPHER Registry; an assessment of the influence of age on the outcomes of the ARTS II Study, which was designed to determine the role of the CYPHER® Stent in patients with multi-vessel disease; and the angiographic sub-study results of the TYPHOON Study, a multi-center, randomized trial comparing the CYPHER® Stent vs. bare-metal stents in primary angioplasty for acute myocardial infarction (heart attacks).
In addition, WCC 2006 will feature the unveiling of significant independent head-to-head data, including:
SIRTAX Study: Two-year findings from the independent study examining the clinical outcomes of patients treated with the CYPHER® Stent or the Taxus Stent will be presented by Stephan Windecker, M.D., Bern University, Switzerland, on Sept. 5 at 2 p.m. (Central European Summer Time - CEST). The head-to-head study is considered groundbreaking and Dr. Windecker was recently awarded the American College of Cardiology's Innovator of the Year Award for this clinical trial.
Innovation
WCC 2006 will provide a first glimpse into the first third-generation drug-eluting stent, the CYPHER SELECT(TM) Plus Stent. Recently approved for commercialization in the European Union and designed to provide exceptional deliverability to treat vessels that are difficult to navigate, as well as the widely recognized safety and efficacy of the CYPHER® Stent, the CYPHER SELECT(TM) Plus Stent will be highlighted throughout the medical conference. Activities include hands-on demonstrations at the Cordis booth and first-time use of the device during surgical interventions to be broadcast live. A Cordis-sponsored live case will take place on Sept. 3 at 2 p.m. (CEST).
The multinational rollout of the CYPHER SELECT(TM) Plus Stent will follow WCC 2006, starting on Sept. 20. The new device is expected to be available in most countries in Europe, the Middle East, Africa, Latin America and Asia Pacific by the end of 2006.
Other new Cordis technologies that will be featured during the conference include the STEER-IT(TM) Deflecting Tip Guidewire and the CRESCENDO(TM) Rapid Exchange PTCA Dilatation Catheter. Recently made available in Europe, the United States and Canada, the STEER-IT(TM) Guidewire is the first guidewire to offer a tip that can be manipulated to bend in two directions. The CRESCENDO(TM) Balloon is an advanced percutaneous transluminal coronary angioplasty (PTCA) balloon that features a flexible, soft tip designed to reduce vessel injury. It was recently released in the European Union and is scheduled to launch in most other countries, except the United States, Japan and Canada, by the end of 2006.
As Dr. Donohoe noted, "Cordis was founded to revolutionize the treatment of vascular diseases and this commitment continues to guide us to this day."
Education
Cordis Corporation and some of its European affiliates will also host an educational symposium during WCC 2006 titled "DES: What Matters Most?" During the symposium, well-regarded physicians, such as moderators Carlo Di Mario, M.D., Ph.D., Royal Brompton and Harefield National Health Service (NHS) Trust, United Kingdom; and Bernhard Meier, M.D., Bern University, Switzerland, will discuss the performance of different drug-eluting stents and the significance of key clinical measures. The symposium will be held on Sept. 5 at 2 p.m. (CEST) in the Athens room at the convention site.
Cordis Corporation and some of its European affiliates will also promote the recently minted Cordis® Cardiac & Vascular Institute(SM) (CCVI). The Cordis® Cardiac & Vascular Institute(SM), with units located in several countries, was announced to the public in April 2006 and is being developed as a world-class network of educational and clinical resources for physicians and other health care providers to advance the understanding and treatment of a broad range of cardiac and vascular conditions. More information about the CCVI units and their programs will be available at the Cordis booth.
"Supporting our physicians and health care providers with first-class training and information to improve the quality of care for patients is a priority at Cordis," said Dr. Donohoe. "We recognize that education is important to the successful application of any therapeutic technology, which is why Cordis Corporation and its affiliates invest heavily in continuing education opportunities like the symposium at WCC 2006 and the Cordis® Cardiac & Vascular Institute(SM)."
In addition, Cordis will update physicians about various regulatory applications for the CYPHER® Stent, including the U.S. Food and Drug Administration regulatory submission for the CYPHER® 2.25 Stent. Cordis recently received a letter from the agency that is the subject of ongoing discussions between the parties.
More information about WCC 2006 can be found at: http://www.worldcardio2006.org/.
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. 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.
CONTACT:
Mariela Melendez of Cordis Corporation,
+1-786-313-2776,
Cell:+1-786-218-4084,
MMelen10@crdus.jnj.com;
or Todd Ringler of Edelman,
+1-212-704-4572,
Cell: +1-617-872-1235,
Todd.Ringler@edelman.com
Web site:
http://www.cordis.com/
http://www.worldcardio2006.org/
