FDAnews Device Daily Bulletin


June 26, 2006

Cordis' Cypher Select Plus has become the first third-generation drug-eluting stent to receive CE Mark approval, the company announced. Cordis, a unit of Johnson & Johnson, will begin launching the product in Europe in September with full market launch by the end of the year.

"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, director of invasive cardiology at La Tour Hospital in Geneva, Switzerland, and the coordinating investigator of e-Select registry, a global registry designed to assess the performance of the Cypher Select family of stents in daily clinical practice.

The Cypher Select Plus features the "Cyph2onic" hydrophilic coating technology, which is more lubricious than previous Cypher stent products, increasing a physician's ability to successfully navigate challenging coronary arteries.

In 2004, Cordis introduced the first second-generation drug-eluting stent, the Cypher Select outside the U.S.

Sirolimus, the active drug released for the stent, is marketed by Wyeth under the name Rapamune.