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Boston Scientific Announces FDA Approval and U.S. Launch of ION™ Platinum Chromium Stent System
Date:4/25/2011

cheman, Executive Vice President and Group President, Cardiology, Rhythm and Vascular for Boston Scientific.  "We believe the PtCr platform sets a new standard for drug-eluting stent performance and represents the future of coronary stenting."

The ION Stent offers physicians and their patients the broadest size matrix on the market, and includes both monorail® and over-the-wire versions, with sizes ranging in diameter from 2.25 mm to 4.00 mm and lengths of 8 mm to 38 mm.Outside the U.S., including CE Mark countries where it was approved in May 2010, the ION Stent System is commercialized as the TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System.  The ION Stent is backed by the proven safety and efficacy of the TAXUS clinical program, which spans 10 years of research in nearly 50,000 patients in 28 pre- and post-market studies.

The ION Stent has been evaluated in the PERSEUS trial, which reported 12-month results in March 2010, demonstrating positive safety and efficacy outcomes in workhorse lesions compared to the TAXUS® Express2® Stent System.  The PERSEUS clinical program compared the ION Stent to prior-generation Boston Scientific stents in more than 1,600 patients in two parallel trials at 90 centers worldwide.  In April 2011, results from an analysis of pooled patient-level data from 2,298 patients enrolled in the PERSEUS and TAXUS ATLAS clinical trials showed that the ION Stent demonstrated significantly lower rates of major adverse cardiac events, target lesion failure and myocardial infarction compared to the TAXUS® Liberte® Paclitaxel-Eluting Stent System.

"The positive clinical data from our PtCr Series trials support the acute performance benefits provided by our new platinum chromium stent platform," said Keith D. Dawkins, M.D., Senior Vice President and Chief Medical Officer for Boston Scientific's Cardiology, Rhythm and Vascular Group.  "The PERSEUS data confirmed
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