NG-0630-140-2

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<h2>Indications, Safety, and Warnings</h2> <h3>Indications for Use</h3> <p>The Neuroguard IEP™* 3-in-1 Carotid Stent and Post-Dilatation Balloon System with Integrated Embolic Protection is indicated for improving the carotid luminal diameter in subjects at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below:</p> <ul> <li>Patients with symptomatic stenosis of the common or internal carotid artery with ≥ 50% as determined by angiography using NASCET methodology, OR Patients with asymptomatic stenosis of the common or internal carotid artery with ≥ 80% as determined by angiography using NASCET methodology.</li> <li>Patients with reference vessel diameters 4.0 – 8.0 mm.</li> </ul> <p>This device is also indicated for post-dilation of the stent component with simultaneous capture and removal of embolic material. The Neuroguard IEP™* System should always be used in conjunction with an available primary distal embolic protection device as described in the IFU.</p> <h3>Contraindications</h3> <p>The Neuroguard IEP™* 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection is contraindicated for use in:</p> <ul> <li>Patients in whom anticoagulant and/or antiplatelet therapy is contraindicated;</li> <li>Patients with a known hypersensitivity to nickel-titanium;</li> <li>Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of a guidewire, catheter, introducer sheath, delivery system or embolic protection device;</li> <li>Patients with uncorrected bleeding disorders; </li> <li>Patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.</li> </ul> <h3>Potential Adverse Effects</h3> <p>Complications may occur at any time during or after the procedure. Possible complications include, but are not limited to the following: angina, allergic reactions (including to antiplatelet agents, contrast medium or stent materials), aneurysm, arrhythmias, arterial occlusion/thrombosis at puncture site, bleeding from anticoagulant or antiplatelet medications, bradycardia, carotid artery spasm, cerebral edema, cerebral hemorrhage, cerebral ischemia/transient ischemia attack (TIA), cardiac tamponade, cardiogenic shock, death, detachment and/or implantation of a component, embolism, fever, filter thrombosis/occlusion, groin hematoma with or without surgical repair, heart failure, hematoma, hemorrhage, hypotension/hypertension, infection, ischemia/infarction of tissue/organ, myocardial infarction, pain and tenderness, pericardial effusion, pulmonary edema, pseudoaneurysm at the vascular access site, renal failure/insufficiency, respiratory failure, restenosis of the stented segment, seizure, severe unilateral headache, stent embolization, stent/filter entanglement/damage, stent malapposition, stent migration, stent misplacement, stent thrombosis/occlusion, stroke/cerebrovascular accident (CVA), total occlusion of carotid artery, vessel dissection, perforation, spasm or recoil, vessel trauma requiring surgical repair or reintervention.</p> <p><b>CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.</b></p> <p>Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device, or contact a Medtronic representative.</p> <p>UC202600034EN</p> <p>UC202506059EN</p>

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Customer Care Team