November 3, 2014

Covidien's HawkOne Directional Atherectomy System Cleared by FDA

November 4, 2014—Covidien plc announced US Food and Drug Administration 510(k) clearance for the HawkOne directional atherectomy system, which provides physicians with an enhanced cutting mechanism to more effectively treat the widest variety of plaque in patients with peripheral arterial disease.

The HawkOne is an addition to Covidien’s directional atherectomy portfolio that includes the TurboHawk and SilverHawk systems. The company noted that recently published data from the DEFINITIVE LE study in the Journal of American College of Cardiology: Cardiovascular Interventions demonstrated 95% limb salvage in patients with critical limb ischemia (CLI) and 78% overall patency (the ability for the treated artery to remain open) in claudicant patients at 12 months after treatment with directional atherectomy (2014;7:923–933).

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November 3, 2014

Covidien's HawkOne Directional Atherectomy System Cleared by FDA

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