Boston Scientific Receives FDA Approval for PROMUS Element™ Plus Platinum Chromium Stent System

Boston Scientific has announced that it has received U.S. Food and Drug Administration (FDA) approval for the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System.

As far back as October 2009 Boston Scientific received CE Mark approvals for the PROMUS Element Everolimus-Eluting Stent System. It subsequently received CE Mark approval for the TAXUS® Element Paclitaxel-Eluting Stent System in May 2010, and the OMEGA™ Bare-Metal Coronary Stent System in February 2011.

Now it has announced that it has received U.S. Food and Drug Administration (FDA) approval for the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System, the Company’s next-generation drug-eluting stent (DES) technology.

The PROMUS Element Stent, designed to provide physicians with improved Drug Eluting Stent (DES) performance in treating patients with coronary artery disease, is built on an innovative platinum chromium (PtCr) platform with the market-leading everolimus drug.

The Company plans to begin marketing the product in the U.S. immediately

To read the Boston Scientific Press Release in full click here.

Source: Boston Scientific

published: November 23, 2011 in: Approval/Clearance, Boston Scientific, Cardio, Regulatory, USA

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