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 (877) 526-7890. Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions.
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™ peripheral 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.
Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.
FTSOP113326-55 Rev. 1B