SPD2-US-030-320

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Indications, Safety, and WarningsNote: Safety information provided is for the United States. 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. Prior to use, refer to the instructions for use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings, and precautions.Important informationIndications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device.Indications for useLower extremity (LE) interventionsThe 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 interventionsThe 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 3.0 mm and 7.0 mm.Saphenous vein graft (SVG) interventionsThe 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 3.0 mm to 6.0 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral vasculature.Caution: Federal law (United States) restricts this product for sale by or on the order of a physician.FTSOP113326-73 Rev. 1A

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