Medtronic receives FDA clearance of new lower profile HawkOne 6F directional atherectomy system


HawkOne Medtronic has received US Food and Drug Administration (FDA) 510(k) clearance for the HawkOne Directional Atherectomy System in a new size for treating patients with peripheral artery disease. The HawkOne system is designed to remove plaque from the vessel wall and restore blood flow. The new HawkOne 6 French (6F) provides an effective and easy-to-use treatment option for patients with peripheral artery disease both above and below the knee with a single device at a lower profile.

“Considering the complex disease pattern seen in below-the-knee peripheral artery disease, traditional treatment options such as placement of permanent stents or treatment with a balloon, may not be ideal for achieving long-term results. Directional atherectomy, on the other hand, is an established intervention that not only restores patency but also maximises luminal gain while keeping future treatment options open,” said Brian DeRubertis, associate professor of surgery at the David Geffen School of Medicine at UCLA. “The new, smaller HawkOne 6F device further adds to the versatility of this directional atherectomy system and enables us to treat a larger set of patients with more complex lesions, including patients with challenging calcified lesions.”

The HawkOne 6F size is an advanced option to treat patients with multi-level peripheral artery disease both above and below the knee, addressing lesions of various length, morphology, and location. Key benefits of the system include:

  • Treating calcified lesions: The HawkOne system enables physicians to treat severe calcified lesions more efficiently with no increase in cut depth. The system can treat calcified lesions up to two times more effectively than the TurboHawk device.
  • Ease of use: The HawkOne system has a preloaded flush tool, which improves cleaning time by up to 55% when compared to the TurboHawk high efficiency cutter. The 6F size is also designed to simplify device selection and provide easy set-up with no capital equipment.

“The expansion of our HawkOne system provides physicians with more options to optimise directional atherectomy as an approach to peripheral artery disease management, particularly for lesions below the knee,” said Mark Pacyna, vice president and general manager of the Peripheral business, which is part of the Aortic & Peripheral Vascular division at Medtronic. “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.”