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

nts experienced significant clinical improvement from baseline to nine months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing.  An additional measure of effectiveness based on the Rutherford Classification showed improvement in the patient population from 7.2 percent being asymptomatic or having mild claudication (class 0-1) at baseline to 82.3 percent of patients at 30 days and 81.6 percent at nine months.  Duplex ultrasound showed a primary patency of 95.9 percent, primary-assisted patency of 96.7 percent and secondary patency of 98.3 percent, indicating that treated lesions remained open through the nine-month follow-up period.

"We are pleased to report positive outcomes for U.S. patients in the ORION clinical trial.  The Epic Stent has been used successfully in Europe for several years and we look forward to offering the device to U.S. physicians upon FDA approval," said Jeff Mirviss, President of Boston Scientific's Peripheral Interventions business.  "The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems.  Upon approval, the Epic Stent along with the market-leading Express® LD balloon-expandable iliac stent, would enable Boston Scientific to offer a complete line of advanced iliac solutions for physicians and patients."

The Epic Stent is a self-expanding nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement.  It employs an innovative Tandem Architecture™, which is engineered to provide excellent stent flexibility while maintaining predictable radial force characteristics across the entire stent size matrix.  The Epic Stent is compatible with 6F sheaths, and the stent delivery system is compatible with 0.035 inch guidewires. 

ORION clinical data is being used to support application for U.S. Food and D
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SOURCE Boston Scientific Corporation
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