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Boston Scientific Begins Clinical Trial for Next-Generation Nitinol Stent to Treat Iliac Artery Disease
Date:5/20/2009

NATICK, Mass., May 20 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced the start of patient enrollment in the ORION clinical trial, which is designed to evaluate the Company's EPIC(TM) Self-Expanding Nitinol Stent System for the treatment of iliac artery disease, a form of peripheral artery disease that impacts a patient's lower extremities. The first U.S. patient was enrolled on May 14 by Nicolas W. Shammas, M.D., at Trinity Terrace Park Hospital in Bettendorf, Iowa.

"Peripheral stenting has become a recognized standard in the treatment of iliac arterial disease," said Daniel Clair, M.D., FACS, Principal Investigator of the trial and Chairman of the Department of Vascular Surgery, The Cleveland Clinic Foundation. "The ORION clinical trial will provide important data on the performance of the EPIC Stent in the treatment of atherosclerotic lesions in iliac arteries."

"We are encouraged by the early positive response to our EPIC Stent in Europe, where it was launched last month, and we are pleased to begin the process of evaluating it for use in the United States," said Donald S. Baim, M.D., Chief Medical and Scientific Officer of Boston Scientific. "The EPIC Stent is designed to offer a more balanced stent platform, allowing for excellent radial force without compromising stent flexibility and providing physicians a new option for treating iliac disease."

The EPIC Stent is a self-expanding nitinol stent designed to sustain vessel patency (openness), while providing enhanced visibility during placement. The ORION trial incorporates stent diameter ranges from 6-12 mm and lengths up to 120 mm. All stent sizes are compatible with 6F (2.1 mm) sheaths, and the stent delivery system is compatible with 0.035'' (0.89 mm) guidewires.

The trial will enroll 123 patients at
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SOURCE Boston Scientific Corporation
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