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Indications, Safety, and Warnings HawkOne™ Directional Atherectomy System

Note: Safety information provided is for the United States. Please refer to your region’s Instructions for Use for specific details.

This therapy is not for everyone. Please consult your physician. A prescription is required. For more information, please call Medtronic at 763-514-4000 (worldwide). Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings, and precautions.

Reference statement

Important Information: Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: 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.

Potential Adverse Effects of the Device on Health: The potential complications include, but are not limited to, amputation, aneurysm, arterial dissection, arterial perforation, arterial rupture, arterial spasm, arteriovenous fistula, bleeding complications, death, embolism or arterial thrombosis, emergency or non-emergency arterial bypass surgery, entry site complications, hypotension, infection, ischemia, restenosis of the treated segment, total occlusion of the peripheral artery, or vascular complications that could require surgical repair.

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

FTSOP113326-55 Rev. 1B

Related page

HawkOne directional atherectomy system

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Phone: 763-514-4000

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