FDA Approves BSX Stent System
Natick-based Boston Scientific Corp. has received approval from the U.S. Food and Drug Administration (FDA) on its new stent system designed to treat coronary heart disease.
The company announced Monday that the Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System is available immediately in the U.S. and the first implantation will be carried out by Dr. Martin Leon, director at the Center for Interventional Vascular Therapy at Columbia University Medical Center in New York City.
According to Boston Scientific, the stent system is unique because it features customized platinum chromium alloy stent architecture and employs the company’s market leading drug, Everolimus. Leon said in a statement said this technology offers “unparalleled visibility” and “enhanced customized stent architecture.”
Coronary heart disease is a narrowing of the blood vessels that supply blood and oxygen to the heart, and placement of a stent system helps keep an artery open to enhance blood flow.
Kevin Ballinger, president of Boston Scientific’s Interventional Cardiology business, said the company expects to continue investing in its leading platinum chromium platform, following the latest FDA approval.
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