Covidien's HawkOne Directional Atherectomy System Receives FDA 510(K) Clearance For The Treatment Of Peripheral Arterial Disease

Covidien plc

today announced U.S. Food and Drug Administration 510(k) clearance for the HawkOne™ directional atherectomy system. The latest addition to Covidien's directional atherectomy portfolio, the HawkOne™ system provides physicians with an enhanced cutting mechanism to more effectively treat the widest variety of plaque in patients with peripheral arterial disease (PAD). PAD affects more than 202 million people worldwide1 and more than 10 million people in the U.S.2 It occurs when arteries in the legs become narrowed or blocked by plaque, and it can cause severe pain, limited physical mobility and non-healing leg ulcers. PAD can also lead to serious health consequences such as amputation, cardiovascular disease and death. “Covidien is committed to being the clear first choice for our physician and hospital partners by delivering new innovative technologies that help save and improve patient lives,” said Brian Verrier, president, Peripheral Vascular, Covidien. “The FDA clearance of the HawkOne™ system enhances our leading peripheral vascular portfolio and further demonstrates Covidien's leadership in the atherectomy space.” Covidien's directional atherectomy portfolio includes the TurboHawk™ and SilverHawk™ systems and is backed by more than 15 peer-reviewed studies. Recent published data from the DEFINITIVE LE study in the Journal of American College of Cardiology, Cardiovascular Interventions demonstrated 95 percent limb salvage in patients with critical limb ischemia (CLI) and 78 percent overall patency (the ability for the treated artery to remain open) in claudicant patients at 12 months following treatment with directional atherectomy.3