Medtronic Launches HawkOne System in the U.S.

Medtronic is launching its HawkOne directional atherectomy system in the U.S., following FDA 510(k) clearance in November, the Ireland-based devicemaker announced Thursday. The company is seeking CE Mark approval, a spokeswoman told Device Daily.

The HawkOne system combats plaque build-ups, including severely calcified blockages, in patients suffering from peripheral arterial disease. Calcium blockages, seen across a wide range of chronic conditions, often are correlated with lower procedural success and substandard outcomes.

The system was demonstrated to treat calcified lesions with up to two times better efficacy than the devicemaker’s earlier-generation PAD system, the company claims. In addition, the HawkOne’s preloaded cleaning tool boosts cleaning time up to 55 percent when compared with the TurboHawk High Efficiency Cutter.

Containing a lower crossing profile, the HawkOne system features improved sheath delivery and enables health professionals to more consistently cross difficult lesions, the devicemaker added.

PAD occurs when lower extremity arteries narrow or contain blockages and can cause severe pain, diminished physical mobility and non-healing leg ulcers. Serious health consequences may result, including amputation, cardiovascular disease and death. More than 202 million people are afflicted with PAD worldwide, with more than 10 million in the U.S.

Study results found in the Journal of American College of Cardiology, Cardiovascular Interventions indicate that 12-month directional atherectomy treatment enabled limb salvage rates of 95 percent in patients with critical limb ischemia and overall patency rates of 78 percent in claudicant patients, the devicemaker said.

Medtronic acquired the HawkOne, TurboHawk and SilverHawk systems as part of its $50 billion acquisition of Covidien. — Jason Scott