Medtronic (NYSE:MDT) said it’s launching the HawkOne device it acquired when it paid $50 billion for Covidien early this year.
HawkOne, a directional atherectomy device, is designed to treat severely calcified lesions in the blood vessels of the lower extremities.
The device won 510(k) clearance from the FDA last November, just a few months before Medtronic closed the largest merger in medtech history.
"Based on physician feedback and collaboration, we have developed a technology that enables physicians to treat lower extremity PAD more efficiently and effectively," peripheral vascular general manager Brian Verrier said in prepared remarks. "The HawkOne system enhances our directional atherectomy platforms and reinforces our commitment to therapy innovation by providing physicians and patients with new treatment solutions that protect limbs and enhance lives.”
Medtronic’s directional atherectomy line also includes the TurboHawk and SilverHawk systems. Study results published in the Journal of American College of Cardiology, Cardiovascular Interventions showed a 95% limb salvage rate in patients with critical limb ischemia and 78% overall patency in claudicant patients at 12 months, the company said.