FDA Clears Covidien HawkOne™ Directional Atherectomy System for Peripheral Arterial Disease

It feels like Covidien is never far from the headlines at the moment. Now the soon-to-be Medtronic mergee, has gained U.S. FDA 510(k) clearance for its HawkOne™ directional atherectomy system.


Peripheral Artery Disease (PAD) affects millions of people. It occurs when arteries in the legs become narrowed or blocked by plaque, and 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, so frequently demands therapeutic intervention.

Recent published data from the DEFINITIVE LE study in the Journal of American College of Cardiology, Cardiovascular Interventions resulted in 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.

The latest addition to Covidien’s directional atherectomy portfolio, the company says the HawkOne™ system provides physicians with an enhanced cutting mechanism to more effectively treat the widest variety of plaque in patients with PAD. It complements Covidien’s directional atherectomy portfolio, which includes the TurboHawk™ and SilverHawk™ systems.  

Company comments

“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.”

Source: Covidien, plc.

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