SERB65-14-60-80

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<h2>Indications, Safety, and Warnings</h2> <p><b>Note: Safety information provided is for the United States. Refer to your region’s instructions for use for specific details.</b></p> <p>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. </p> <h3>Indications</h3> <p>The Protégé™ GPS™ self-expanding peripheral biliary stent system is indicated for improving luminal diameter in patients with atherosclerotic disease of the common and/or external iliac arteries up to and including 100 mm in length, with reference vessel diameters of 7.5 mm to 11 mm. </p> <p>The stent is intended as a palliative treatment of malignant neoplasms in the biliary tree.</p> <h3>Contraindications </h3> <p>Use of the Protégé™ GPS™ self-expanding peripheral biliary stent 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.</p> <h3>Potential adverse events </h3> <p>Potential adverse events which may be associated with the use of a stent in the common and/or external iliac arteries include, but are not limited to: abrupt or sub-acute closure, allergic reaction to device materials or procedure medications, allergic reaction to nitinol, amputation, aneurysm, angina, arrhythmia, arterio-venous fistula, artery injury (e.g., dissection, perforation, or rupture), bleeding requiring transfusion, bruising, contrast medium reaction/renal failure, death, device breakage, edema, 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 failure, renal insufficiency, restenosis, sepsis, shock, stent collapse or fracture, stent migration, stent misplacement, stroke, surgical or endovascular intervention, thrombosis/occlusion of the stent, transient ischemic attack, venous thromboembolism, vessel spasm, worsening claudication or rest, pain.</p> <p>See the instructions for use provided with the product for a complete list of warnings, precautions, adverse events, and device information. </p> <p><b>Caution: </b>Federal law (United States) restricts these devices to sale by or on the order of a physician. </p> <p>FTSOP113326-38 Rev. 1A</p>

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