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Video: ev3 Inc. Announces First Patient Enrollments in DEFINITIVE LE Post-Market Study
Date:4/30/2009

ne-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. "Furthermore, this study will potentially add new insight on the optimal management of diabetic patients in this very difficult vascular territory."

Robert Palmisano, ev3's president and chief executive officer, stated, "ev3 has committed to advancing the science of peripheral artery disease treatment with a goal of making plaque excision a frontline therapy. We believe that the additional clinical data generated by our DEFINITIVE study series will provide evidence-based guidance to aid physicians in selecting optimal treatments for their patients, facilitate broader procedure adoption and establish SilverHawk plaque excision as an indispensable tool in combating PAD, a relentlessly progressive disease."

The DEFINITIVE Clinical Study Program

The DEFINITIVE LE study represents the second study in the company's DEFINITIVE clinical study program to confirm the value of plaque excision with the SilverHawk System. A U.S. IDE study, called DEFINITIVE Ca++, is currently underway to evaluate the use of the SilverHawk-R LSC (RockHawk) Plaque Excision System and the SpiderFX(R) Embolic Protection Device in the endovascular treatment of moderate to heavily calcified peripheral artery lesions. For information about the DEFINITIVE LE study and/or to locate physicians participating in the study, contact ev3 clinical affairs by phone at (763) 398-7203 or by email at

SOURCE ev3 Inc.
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