INDICATIONS, SAFETY, AND WARNINGS EverFlex Self-expanding Peripheral Stent with Entrust Delivery 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.
Indication: The EverFlex™ self-expanding peripheral stent with Entrust™ delivery system is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 mm - 7.5 mm.
Contraindications: Use of the EverFlex self-expanding peripheral stent with Entrust delivery system is contraindicated in patients with known hypersensitivity to nickel titanium; patients contraindicated for anticoagulant and/or antiplatelet therapy; patients who have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system. The EverFlex self-expanding peripheral stent with Entrust delivery system is contraindicated for use in the carotid artery.
Potential Adverse Events: Potential adverse events which may be associated with the use of a stent in the SFA and proximal popliteal arteries include, but are not limited to: allergic reaction, amputation, artery perforation or rupture, bleeding requiring transfusion, infection, pseudoaneurysm, restenosis, stent collapse or fracture, stent migration, surgical or endovascular intervention, thrombosis/occlusion of the stent.
See the Instructions for Use provided with the product for a complete list of warnings, precaution, adverse events and device information.
CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.
FTSOP113326-41 Rev. 1A