INDICATIONS, SAFETY, AND WARNINGS SpiderFX Embolic Protection Device

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. 


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: 

Lower Extremity (LE) Interventions
The SpiderFX™ Embolic Protection Device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material in conjunction with the TurboHawk™ Peripheral Plaque Excision System, either during standalone procedures or together with PTA and/or stenting, in the treatment of severely calcified lesions in arteries of the lower extremities. The vessel diameter at the filter basket placement site should be between 3.0 mm and 6.0 mm.

Carotid Interventions
The SpiderFX Embolic Protection Device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be between 3.0mm and 7.0mm.

Saphenous Vein Graft (SVG) Interventions
The SpiderFX Embolic Protection Device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0mm to 6.0mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral vasculature.

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

FTSOP113326-73  Rev. 1A