Boston Scientific (NYSE:BSX) said the FDA granted pre-market approval for its next-generation coronary stent, the Promus Premier.
Natick, Mass.-based Boston Scientific said it plans an immediate release for the Promus Premier, a drug-eluting stent made of a platinum-chromium alloy coated with everolimus.
"The Promus Premier stent system reflects our commitment to DES technology and to providing interventional cardiologists with the most complete portfolio of clinical solutions," interventional cardiology president Kevin Ballinger said in prepared remarks. "Through ongoing collaboration with physicians, we expect to continue to innovate and build on our industry-leading platinum chromium platform."
The Promus Premier won CE Mark approval in the European Union in February.
Boston Scientific said the 1st U.S. implantation is slated to be performed by Dr. Martin Leon of the Center for Interventional Vascular Therapy at Columbia University Medical Center / New York-Presbyterian Hospital.
"It’s very rewarding, professionally, to be the first to provide this new DES therapy to my patients," Leon said in prepared remarks. "Perhaps the most impressive benefit of the Promus Premier stent system is its unparalleled visibility, which combined with enhanced customized stent architecture, leads to an advance in currently available durable polymer DES."