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January 23, 2017
CE Mark Approval for Medtronic's HawkOne 6-F Directional Atherectomy System
January 24, 2017—Medtronic announced that is has received European CE Mark approval for its HawkOne directional atherectomy system in a lower-profile size to patients with peripheral artery disease (PAD) 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.
According to Medtronic, the HawkOne system's preloaded flush tool improves cleaning time by up to 55% when compared to the company's TurboHawk high-efficiency cutter. The 6-F size is designed to simplify device selection and provide easy setup with no capital equipment.
In the company's press release, Professor Thomas Zeller, MD, commented, "Directional atherectomy is an established treatment modality for patients with complex PAD to restore patency, maximize luminal gain, and preserve future treatment options. The new smaller HawkOne 6-F size is an advanced option to treat patients with multilevel PAD, addressing lesions of various length, morphology, and location, particularly those below the knee." Prof. Zeller is Head of the Department of Angiology at Universitäts-Herzzentrum Freiburg in Bad Krozingen, Germany.
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