Medtronic Receives Clearance for Lower-Profile HawkOne 6-F Directional Atherectomy System

October 24, 2016—Medtronic plc announced US Food and Drug Administration 510(k) clearance for its HawkOne directional atherectomy system in a new 6-F size to provide a treatment option for patients with peripheral artery disease (PAD) with a single device at a lower profile. The HawkOne system is designed to treat patients with multilevel PAD both above and below the knee, addressing lesions of various length, morphology, and location.

In the company’s announcement, Brian DeRubertis, MD, commented, “Considering the complex disease pattern seen in below-the-knee PAD, 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 maximizes luminal gain while keeping future treatment options open.”

Dr. DeRubertis continued, “The new, smaller HawkOne 6-F 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.” Dr. DeRubertis is Associate Professor of Surgery at the David Geffen School of Medicine at UCLA in Los Angeles, California.