Lesions in the ostium of the common carotid artery.Patients with known allergies to nitinol.Patients with uncorrected bleeding disorders.Patients in whom the ENROUTE Transcarotid NPS is unable to be placed.Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated.Please refer to Instructions for Use for indications, contraindications, warnings and precautions.Ĭaution: Federal (U.S.) law restricts this device to sale by or on the order of a physician.Ĭontraindications: Use of the ENROUTE Transcarotid Stent System is contraindicated in the following patients: Carotid bifurcation is located at minimum 5 cm above the clavicle to allow for placement of the ENROUTE Transcarotid NPS.Patients must have a vessel diameter of 4-9 mm at the target lesion, AND.Patients with neurological symptoms and › 50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and › 80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND.Indications for Use: The ENROUTE® Transcarotid Stent System used in conjunction with the ENROUTE Transcarotid Neuroprotection System (NPS) is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy, who require carotid revascularization and meet the criteria outlined below.
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