Definitive LE is a prospective, multi-center, single-arm study to evaluate the intermediate and long-term effectiveness of stand-alone SilverHawk plaque excision therapy for endovascular treatment of lower extremity peripheral arterial disease.
Up to 800 patients are expected to be enrolled from 50 clinical sites throughout the US and Europe. The study will evaluate one-year patency in patients with leg pain and one-year limb salvage in patients with critical leg ischemia and include third party review of results by independent core-labs.
The Definitive LE study results are expected to add to the growing body of data supporting SilverHawk therapy in patients with peripheral arterial disease(PAD).
Robert Palmisano, president and CEO of ev3, said: “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.”