Covidien’s HawkOne Directional Atherectomy System Receives FDA 510(K)

Nov. 5, 2014 — Food and Drug Administration gave 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).

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 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 in claudicant patients at 12 months following treatment with directional atherectomy.

For more information: www.covidien.com