INDICATIONS, SAFETY, AND WARNINGS Visi-Pro Balloon-expandable Peripheral and Biliary Stent 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. 


REFERENCE STATEMENT

Indications: The Visi-Pro™ balloon-expandable peripheral stent system is indicated for improving luminal diameter in patients with atherosclerotic disease of the common and/or external iliac arteries up to 100 mm in length, with a reference vessel diameter of 5 to 10 mm.

The Visi-Pro balloon-expandable biliary stent system is intended as a palliative treatment of malignant neoplasms in the biliary tree.

Contraindications: Use of the Visi-Pro balloon-expandable peripheral stent system is contraindicated in patients with known hypersensitivity to stainless steel or its components; patients contraindicated for anticoagulant and/or antiplatelet therapy; patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site; perforation at the angioplasty site; aneurysm of the artery to be treated.

Potential Adverse Events: Potential adverse events which may be associated with the use of a stent in the Iliac arteries include, but are not limited to: Abrupt or sub-acute closure , Allergic reaction to 316L stainless steel, Allergic reaction to device materials or procedure medications, Amputation, Aneurysm, Angina, Arrhythmia, Arterio-venous fistula, Artery injury (e.g., dissection, perforation or rupture), Bleeding requiring transfusion, Contrast medium reaction/renal failure, Death, Device breakage, Embolism, Failure to deploy stent, Fever, Gastrointestinal bleeding due to anticoagulation, Hematoma, Hypertension/Hypotension, Infection, Inflammation, Intraluminal thrombus, Myocardial infarction, Pain, Partial stent deployment, Pseudoaneurysm, Renal insufficiency, Restenosis, Sepsis, Shock, Stent collapse or fracture, Stent migration, Stent misplacement, Stroke, Surgical or endovascular intervention,Thrombosis/occlusion of the stent, Transient increase in glomerular filtration rate, Transient ischemic attack, Venous thromboembolism, Vessel spasm, Worsening claudication or rest pain.

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.

FTSOP113326-37 Rev. 1A