FDA expands approval of HawkOne Directional Atherectomy System for peripheral artery disease- Medtronic
Medtronic has received U.S. FDA 510(k) clearance for the HawkOne Directional Atherectomy System in a new size for treating patients with peripheral artery disease (PAD). 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 PAD both above and below the knee with a single device at a lower profile. The expansion of the HawkOne system provides physicians with more options to optimize directional atherectomy as an approach to PAD management, particularly for lesions below the knee. The original system was FDA approved in 2014.
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