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Boston Scientific Epic™ Stent Demonstrates Positive Clinical Outcomes in Orion Trial
Date:1/16/2012

NATICK, Mass. and MIAMI, Jan. 16, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) reports nine-month clinical endpoint data from its ORION trial, demonstrating excellent outcomes for the Company's Epic™ Self-Expanding Nitinol Stent System in patients with iliac artery disease, a form of peripheral artery disease associated with severe leg pain caused by insufficient blood flow.  Results were presented today by Daniel Clair, M.D., FACS, Principal Investigator of the trial and Chairman of the Department of Vascular Surgery, The Cleveland Clinic Foundation, at the International Symposium on Endovascular Therapy (ISET) in Miami.

"Peripheral stenting has become a recognized standard in the treatment of iliac arterial disease to restore blood flow in blocked leg arteries," said Dr. Clair.  "Outcomes from the ORION trial support both the safety and efficacy of the Epic Stent and confirm its excellent performance in the treatment of atherosclerotic lesions in iliac arteries."

The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the U.S.  The trial met its primary endpoint, a composite rate of device- and/or procedure-related major adverse events (MAE) at nine months.  MAE are defined as death within 30 days, myocardial infarction (MI, or heart attack) occurring during hospitalization, target vessel revascularization (TVR) through nine months and amputation of the treated limb through nine months.  The Epic Stent demonstrated a low nine-month MAE rate of 3.4 percent in the intent-to-treat population, which was significantly lower than the pre-specified performance goal of 17 percent (p<0.001) based on historical published outcomes for iliac stenting.  All reported major adverse events were related to TVR.  No deaths through 30 days and no amputations through nine months were observed.

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