Largest Study to Date Will Evaluate SilverHawk Plaque Excision System for Treatment of Lower Extremity Peripheral Arterial Disease
PLYMOUTH, Minn., April 30 /PRNewswire/ -- ev3 Inc. (Nasdaq: EVVV) today announced that the first patients were recently enrolled in the DEFINITIVE LE post-market study. DEFINITIVE LE is a prospective, multi-center, single-arm study to evaluate the intermediate and long-term effectiveness of stand-alone SilverHawk(R) Plaque Excision therapy for endovascular treatment of lower extremity peripheral arterial disease (PAD). Stuart Harlin, M.D., of Sacred Heart Hospital in Pensacola, Florida and Prakash Makam, M.D., of Community Hospital in Munster, Indiana enrolled the first two patients.
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(Photo: http://www.newscom.com/cgi-bin/prnh/20090430/NY08452 )
'The SilverHawk Plaque Excision System offers patients an effective and minimally-invasive treatment option for PAD, and I believe DEFINITIVE LE will validate the utility of plaque excision under real world conditions,' said James McKinsey, M.D., Interim Chief of Vascular Surgery of New York Presbyterian Hospital System and the Universities of Columbia and Cornell, New York and co-principal investigator for the DEFINITIVE LE study.
The DEFINITIVE LE study results are expected to add to the growing body of data supporting SilverHawk therapy in patients with PAD. Up to 800 patients are expected to be enrolled from 50 clinical sites throughout the United States and Europe. The study will evaluate one-year patency in patients with leg pain (claudication) and one-year limb salvage in patients with critical leg ischemia (CLI) and include third party review of results by independent core-labs.
'As one of the most robust plaque excision studies to date, DEFINITIVE LE will provide much needed guidance on the treatment of PAD using plaque excision in both above- and below-the-knee applications,' said co-principal investigator Lawrence Garcia, M.D., Chief of Interventional Cardiology and Associate Director of Vascular Medicine at St. Elizabeth's Medical Center, Boston.
