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| Covidien's TurboHawk device--Courtesy of Covidien |
Medtronic ($MDT) announced the U.S. launch of its HawkOne directional atherectomy system, for surgical treatment of peripheral artery disease, or blocked and calcified arteries in the arms or legs. The device was obtained via Medtronic's $50 billion acquisition of Covidien.
Medtronic says that the HawkOne can treat calcified lesions more than twice as effectively as its prior generation TurboHawk directional atherectomy device. The company pointed to a study published in the Journal of the American College of Cardiology, Cardiovascular Interventions, which showed directional atherectomy had a 95% limb salvage in patients with critical limb ischemia and 78% effectiveness in keeping treated arteries open in patients at 12 months.
Directional atherectomy devices enter the body via catheter and use a directional cutter that can be positioned within the diseased vessel for optimal performance and increase in blood flow.
"Based on physician feedback and collaboration, we have developed a technology that enables physicians to treat lower extremity PAD (or peripheral artery disease) more efficiently and effectively," said Brian Verrier, the vice president of Medtronic's peripheral vascular division, in a statement. "The HawkOne system enhances our directional atherectomy platforms and reinforces our commitment to therapy innovation by providing physicians and patients with new treatment solutions that protect limbs and enhance lives."
PAD affects more than 10 million people in the U.S. and 202 million people across the globe, Medtronic says. It can cause severe pain, limited physical mobility, amputation, cardiovascular disease and even death.
Medtronic recently launched the In.Pact drug-coated angioplasty balloon for PAD in the U.S., becoming the second company to do so following Bard ($BCR). It went through the more rigorous PMA approval pathway, while Covidien received a 510(k) clearance for the HawkOne in November.
Medtronic justified the acquisition of Covidien based on its complementary portfolio of "mid tech" offerings (as opposed to high tech devices requiring PMA approval) that tended be focused surgical intervention.
The HawkOne fits that profile.
- read the release