SilverHawk™ Plaque Excision System
The SilverHawk plaque excision system treats peripheral arterial disease (PAD) by removing plaque buildup in the arteries of the leg. Unlike other methods of restoring blood flow, the SilverHawk device removes the obstruction—plaque build-up—instead of simply compressing it against the vessel wall. Directional atherectomy with the SilverHawk device enables physicians to maximize lumen gain and minimize barotrauma without leaving any implant behind. This allows preservation of the native vessel and future treatment options.
DEFINITIVE LE Clinical Summary
The DEFINITIVE LE study is one of the largest multinational, multicenter PAD device studies to date, enrolling 800 patients from 47 sites in the U.S. and Europe. It provides insight into the clinical utility of directional atherectomy with the TurboHawk™ and SilverHawk devices in a broad range of patients, including diabetics, non-diabetics, claudicants, and those with critical limb ischemia (CLI).