Medtronic initiates US launch of HawkOne directional atherectomy system


Medtronic has initiated the US launch of the HawkOne directional atherectomy system. The HawkOne system can be used to treat all plaque morphologies in patients with peripheral arterial disease, including patients who have plaque blockages that have become severely calcified. 

Medtronic says that the HawkOne system enables operators to treat severe calcium more efficiently, and the technology design improves lesion engagement. In benchtop testing, the system was able to treat calcified lesions up to two times more effectively than the TurboHawk device.

“I use directional atherectomy in my practice because of its ability to achieve luminal gain and restore patency,” said Mark Fugate, University Surgical Associates, Chattanooga, USA, who performed the first case in the USA 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 peripheral arterial disease.”

A Medtronic press release states that the HawkOne system’s design also streamlines procedural efficiency, with 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% when compared to the TurboHawk high efficiency cutter.

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

Medtronic’s directional atherectomy portfolio also includes the TurboHawk and SilverHawk systems and is backed by more than 15 peer-reviewed studies. Recently published data from the DEFINITIVE LE study in the Journal of American College of Cardiology, Cardiovascular Interventions demonstrated 95% limb salvage in patients with critical limb ischaemia and 78% overall patency in claudicant patients at 12 months following treatment with directional atherectomy.