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Edwards' Resilient Trial Demonstrates Statistically Superior Results for Treating Peripheral Arterial Disease in the Leg
Date:10/23/2007

- Arterial Blockages in the Leg are Estimated to Affect 8 Million Americans

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WASHINGTON, Oct. 23 /PRNewswire-FirstCall/ -- Edwards Lifesciences Corporation (NYSE: EW), a world leader in products and technologies to treat advanced cardiovascular disease, today announced the 12-month results from The RESILIENT Trial, presented as the "Blockbuster" Trial of the Day at the Cardiovascular Research Foundation's 19th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C. The landmark trial demonstrates statistically superior results using the LifeStent self-expanding stent versus balloon angioplasty alone in treating peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery. These arteries are the major circulatory channels for the upper leg and knee.

"The RESILIENT Trial is a randomized, multi-center study using the flexible LifeStent self-expanding stent in the understudied and challenging SFA region," said Barry T. Katzen, M.D., Founder and Medical Director of Baptist Cardiac and Vascular Institute, and co-principal investigator for The RESILIENT Trial. "The results of this trial show the statistical superiority of the LifeStent self-expanding stent versus balloon angioplasty alone as the need for follow-up intervention was 13% versus 54%, respectively, at 12 months."

The RESILIENT Trial further demonstrated the SFA patency rate, or percentage of vessels with unobstructed blood flow, was 80% for patients who received the LifeStent self-expanding stent versus 38% for patients with balloon angioplasty alone.

"Results from The RESILIENT Trial are expected to establish the LifeStent
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SOURCE Edwards Lifesciences Corporation
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