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Medtronic receives CE Mark approval for new HawkOne 6F system
Medtronic has announced that its HawkOne directional atherectomy system has been approved in a lower profile size by European regulators.
The new HawkOne 6 French (6F) system has received European CE Mark approval, offering an easy-to-use treatment option for patients with peripheral artery disease both above and below the knee, using a single device.
Designed to remove plaque from the vessel wall and restore blood flow, the device lets physicians treat severe calcified lesions up to two times more effectively than the TurboHawk system, with no increase in cut depth.
HawkOne also has a preloaded flush tool, which improves cleaning time by up to 55 percent compared to the TurboHawk high efficiency cutter.
Mark Pacyna, vice-president and general manager of Medtronic's peripheral business, said: "The HawkOne 6F system provides physicians with an effective and efficient treatment option for treating peripheral artery disease above and below the knee."
This follows the recent approval of the CoreValve Evolut R 34 mm valve in Europe for the treatment of severe aortic stenosis patients with large anatomies.
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