U.S. Launch of Medtronic’s HawkOne™ Directional Atherectomy System for PAD

Last November, Covidien announced the FDA’s clearance of its HawkOne™  directional atherectomy system for treatment of plaques in peripheral arterial disease (PAD). Fast forward to post-acquisition time to find Medtronic announcing the system’s official U.S. launch.


The HawkOne system provides physicians with a solution to treat all plaque morphologies in patients with peripheral arterial disease, including patients who have plaque blockages that have become severely calcified. Medtronic claims the system enables operators to treat severe calcium more efficiently, its design improving lesion engagement. In benchtop testing, HawkOne was able to treat calcified lesions up to two times more effectively than the TurboHawk™  device.

The HawkOne system’s unique design also streamlines procedural efficiency, with claims of improved crossing and cleaning capabilities. Its lower crossing profile improves sheath deliverability and allows physicians to cross challenging lesions more predictably. The HawkOne system has been enhanced with a preloaded cleaning tool, which improves cleaning time by up to 55 percent when compared to the TurboHawk High Efficiency Cutter.

Physician comments

“I use directional atherectomy in my practice because of its ability to achieve luminal gain and restore patency,” said Dr. Mark Fugate, M.D., University Surgical Associates, Chattanooga, Tenn., who performed the first case in the U.S. with the HawkOne system. “The HawkOne system’s improved crossability and efficient calcium cutting will further enable our ability to effectively and efficiently treat practically any patient with PAD.”

“In the cath lab, we are always looking for new technologies that effectively treat the disease, while improving efficiency in the lab,” said Dr. Louis Lopez, M.D., St. Joseph Hospital, Fort Wayne, Ind. “I was very impressed with the significant improvements of the device’s crossing and cleaning capabilities.”

Company comments

“Based on physician feedback and collaboration, we have developed a technology that enables physicians to treat lower extremity PAD more efficiently and effectively,” said Brian Verrier, Vice President and General Manager, Peripheral Vascular, Medtronic. “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.”

Source: Medtronic, plc

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