H1-LS

Description

The HawkOne™ directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The HawkOne™ catheter is indicated for use in conjunction with the SpiderFX™ embolic protection device in the treatment of severely calcified lesions. The HawkOne™ catheter is NOT intended for use in the coronary, carotid, iliac, or renal vasculature.

Risks may include but are not limited to: arterial perforation, embolism or arterial thrombosis, arterial dissection, arterial spasm, and vascular complications that could require surgical repair.

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