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Boston Scientific Announces Clinical Data Supporting Safety and Efficacy of Platinum Chromium PROMUS Element™ Stent
Date:9/21/2010

e PROMUS Stent to the PROMUS Element Stent," said Keith D. Dawkins, M.D., Senior Vice President and Chief Medical Officer for Boston Scientific's Cardiology, Rhythm and Vascular Group.  "The PLATINUM QCA results further support the performance of the everolimus drug/polymer combination while demonstrating a highly effective platinum chromium PROMUS Element Stent platform.  The PROMUS Element Stent also demonstrates an excellent safety profile in this study with only a single patient experiencing a cardiac event within 30 days and no additional events through nine months."  

"We are extremely pleased with the positive safety and efficacy results of the PLATINUM QCA study, which reinforce the overall benefits provided by our new platinum chromium stent platform," said Hank Kucheman, Executive Vice President and President of Boston Scientific's Cardiology, Rhythm and Vascular Group.  "These favorable outcomes for our everolimus-eluting PROMUS Element Stent, together with the recent European launch of our paclitaxel-eluting TAXUS® Element™ Stent, illustrate our unparalleled pipeline of drug-eluting stent technologies."

The Company expects U.S. Food and Drug Administration approval for the TAXUS Element Stent System (3) in mid 2011 and for the PROMUS Element Stent System in mid 2012.  In Japan, the Company expects approval for the TAXUS Element Stent System in late 2011 or early 2012 and for the PROMUS Element Stent System in mid 2012.

The randomized, controlled PLATINUM Workhorse clinical trial completed enrollment in September 2009 with 1,531 patients at more than 130 sites worldwide and compares the PROMUS Element Everolimus-Eluting Coronary Stent System to the PROMUS (Xience V) Everolimus-Eluting Coronary Stent System.  One-year data from the trial will be presented at the Scientific Session of the American College of Cardiology/i2 Summit in March 2011.  

In the U.S., the PROMUS Element and TAX
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SOURCE Boston Scientific Corporation
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