Medtronic receives CE mark for lower-profile HawkOne directional atherectomy system

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Medtronic HawkOne

Medtronic has been granted CE mark approval for the HawkOne directional atherectomy system in a lower profile size for treating patients with peripheral artery disease. The new HawkOne 6 Fr 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. The HawkOne system is designed to remove plaque from the vessel wall and restore blood flow.

“Directional atherectomy is an established treatment modality for patients with complex peripheral artery disease to restore patency, maximise luminal gain and preserve future treatment options,” says Thomas Zeller, head, Department of Angiology, Universitäts-Herzzentrum Freiburg, Bad Krozingen, Germany. “The new smaller HawkOne 6Fr size is an advanced option to treat patients with multi-level peripheral artery disease, addressing lesions of various length, morphology, and location, particularly those below the knee.”

The HawkOne system is also designed to enable 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, according to a company release. 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 designed to simplify device selection and provide easy set-up with no capital equipment.

“We are excited to announce CE mark approval for HawkOne 6F shortly after receiving FDA clearance for the system in October,” says Mark Pacyna, vice president and general manager of the Peripheral business, which is part of the Aortic & Peripheral Vascular division at Medtronic.