"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," peripheral vascular president Brian Verrier said in prepared remarks. "The FDA clearance of the HawkOne system enhances our leading peripheral vascular portfolio and further demonstrates Covidien’s leadership in the atherectomy space."
Covidien said its directional atherectomy line also includes the TurboHawk and SilverHawk systems, touting study results published in the Journal of American College of Cardiology, Cardiovascular Interventions showing 95% limb salvage in patients with critical limb ischemia and 78% overall patency in claudicant patients at 12 months.
Earlier this week Covidien dealt another portion of its peripheral vascular therapies business, the Stellarex drug-coated balloon, to Spectranetics for $30 million.
Spectranetics said it expects to launch the Stellarex device as soon as it wins CE Mark approval in the European Union, expected in late 2014 or early 2015.