Cordis Corporation, the world leader in the drug-eluting stent market, announced that the company's Cypher Selectt Plus has become the first third-generation drug-eluting stent to receive CE (Communite European) Mark approval. The company will begin launching the product in Europe in September with full market launch by the end of the year.
Featuring an enhanced stent delivery system, 'Cypher Selectt Plus' offers exceptional deliverability and good long-term clinical performance.
"A broad range of clinical studies has demonstrated that the Cypher Stent is an effective and safe treatment for coronary artery disease," said Philip Urban, M.D., F.E.S.C., Director of Invasive Cardiology, La Tour Hospital in Geneva, Switzerland. He is also the coordinating investigator of e-Select Registry, a global registry designed to assess the performance of the Cypher Selectt family of stents in daily clinical practice.
In addition to its flexible stent design and short tip, 'Cypher Selectt Plus' features the CYPH2ONICÔ hydrophilic coating technology, an innovative coating technology that is more lubricious than previous
'Cypher Selectt Plus' showcases Cordis' commitment to the treatment of vascular disease," said Dennis Donohoe, M.D., vice president, Worldwide Clinical and Regulatory Affairs, Cordis Corporation. "The new stent allows ease in delivery and long-term safety profile for the treatment of coronary artery disease. "
With CE mark now secured, the company is aggressively building its manufacturing capacity for the 'Cypher Selectt Plus' launch. The company is committed to ensure that physicians have ready access to the product as it becomes available in various countries outside the U.S.
In 2004, Cordis introduced the first second-generation drug-eluting stent -'Cypher Selectt' outside the United States. The Cypher 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 clinical trial programme constituting 40 studies.
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.