Medtronic has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its new smaller HawkOne 6 French (6F) directional atherectomy system to treat peripheral artery disease (PAD) patients.
The HawkOne system has been designed to remove plaque from the vessel wall and restore blood flow.
The HawkOne 6F size is an advanced option to treat patients with multi-level PAD both above and below the knee, helping to address lesions of various length, morphology and location.
It allows physicians to treat severe calcified lesions more effectively with no increase in cut depth.
The system features a preloaded flush tool that enables to improve cleaning time by up to 55% when compared to the TurboHawk high efficiency cutter
The firm’s directional atherectomy portfolio also features TurboHawk and SilverHawk systems, which were supported by around 15 peer-reviewed studies.
According to the company, PAD is a serious and chronic condition, which affects more than 200 million people and 12 million in the US.
Medtronic aortic and peripheral vascular division’s peripheral business general manager Mark Pacyna said: "The expansion of our HawkOne system provides physicians with more options to optimize directional atherectomy as an approach to PAD management, particularly for lesions below the knee.
"The HawkOne 6F clearance, as well as the recent approval of our 150mm length IN.PACT Admiral drug-coated balloon and clearance of the Trailblazer angled support catheter, reflects our commitment to a full portfolio of products to meet the needs of patients and physicians."
Image: Medtronic operational headquarters, Minneapolis. Photo: courtesy of Medtronic, Inc.