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US Device Guide / Carotid Artery Stenting Systems

Company Name Product Name Tapered Stent Diameters (Proximal/Distal) (mm) Tapered Stent Lengths (mm) Straight Stent Diameters (mm) Straight Stent Lengths (mm) Embolic Protection Device Type Position US FDA Indicated Use
Boston Scientific Corporation Carotid Wallstent Endoprosthesis 6, 8, 10 (unconstrained) 21, 22, 24, 29, 36, 37 (unconstrained) FilterWire EZ Embolic Protection System Filter Distal Used in conjunction with the Boston Scientific EPS, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy due to either anatomic or comorbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease and meet the criteria outlined: patients with neurological symptoms and ≥ 50% stenosis of the common, internal carotid artery, and/or the bifurcation by ultrasound or angiography or patients without neurological symptoms and ≥ 80% stenosis of the common, internal carotid artery, and/or the bifurcation by ultrasound or angiogram, and patients with a reference vessel diameter within the range of 4–9 mm at the target lesion
Silk Road Medical Enroute Transcarotid Stent System Autotapering 20, 30, 40 5, 6, 7, 8, 9, 10 20, 30, 40 Enroute Transcarotid Neuroprotection System Robust flow reversal Proximal 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: 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 patients must have a vessel diameter of 4–9 mm at the target lesion, and carotid bifurcation is located at minimum 5 cm above the clavicle to allow for placement of the Enroute Transcarotid NPS; please refer to instructions for use for indications, contraindications, warnings, and precautions
Cordis, a Cardinal Health company Precise Nitinol Stent System Autotapering 20, 30, 40 5, 6, 7, 8, 9, 10 20, 30, 40 Angioguard XP Emboli Capture Guidewire Filter Distal Used in conjunction with the Cordis Angioguard XP Emboli Capture Guidewire, is indicated for treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the following criteria: patients with neurological symptoms and ≥ 50% stenosis of the common or internal carotid artery by ultrasound or angiography or patients without neurological symptoms and ≥ 80% stenosis of the common or internal carotid artery by ultrasound or angiography and patients must have a vessel diameter of 4–9 mm at the target lesion; the vessel distal to the target lesion must be within the range of 3–7.5 mm to allow for placement of Cordis Angioguard XP Emboli Capture Guidewire
Cordis, a Cardinal Health company Precise Pro RX Carotid Stent System Autotapering 20, 30, 40 5, 6, 7, 8, 9, 10 20, 30, 40 Angioguard RX Emboli Capture Guidewire Filter Distal Used in conjunction with the Cordis Angioguard RX Emboli Capture Guidewire, is indicated for treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the following criteria: patients with neurological symptoms and ≥ 50% stenosis of the common or internal carotid artery by ultrasound or angiography or patients without neurological symptoms and ≥ 80% stenosis of the common or internal carotid artery by ultrasound or angiography and patients must have a vessel diameter of 4–9 mm at the target lesion; the vessel distal to the target lesion must be within the range of 3–7.5 mm to allow for placement of Cordis Angioguard RX Guidewire
Medtronic Protégé RX Carotid Stent System 8/6, 10/7 30, 40 6, 7, 8, 9, 10 20, 30, 40, 60 SpiderFX Embolic Protection Device Filter: guidewire of choice Distal Used in conjunction with the SpiderFX embolic protection device, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet the following criteria: patients with carotid artery stenosis (≥ 50% for symptomatic patients by ultrasound or angiography or ≥ 80% for asymptomatic patients by ultrasound or angiography) of the common or internal carotid artery, and patients must have a reference vessel diameter within the range of 4.5–9.5 mm at the target lesion
Abbott RX Acculink Carotid Stent System 8/6, 10/7 30, 40 5, 6, 7, 8, 9, 10 20, 30, 40 RX Accunet Filter basket Distal High surgical risk: used in conjunction with Abbott Vascular’s Accunet or Emboshield family of EPS, 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 as follows: 1. 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; 2. Patients must have a reference vessel diameter within the range of 4–9 mm at the target lesion; Standard surgical risk: used in conjunction with the Accunet EPS, is indicated for the treatment of patients at standard risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined as follows: 1. Patients with neurological symptoms and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 50% stenosis of the common or internal carotid artery by angiogram or patients without neurological symptoms ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 60% stenosis of the common or internal carotid artery by angiogram; 2. Patients must have a reference vessel diameter within the range of 4–9 mm at the target lesion
Abbott Xact Carotid Stent 8/6, 9/7, 10/8 30, 40 7, 8, 9, 10 20, 30 Emboshield Nav6 BareWire filter delivery wire Distal Used in conjunction with the Emboshield EPS is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease and meet the criteria outlined: patients with carotid artery stenosis (≥ 50% for symptomatic patients by ultrasound or angiography or ≥ 80% for asymptomatic patients by ultrasound or angiography), located between the origin of the common carotid artery and the intracranial segment of the internal carotid artery and patients must have a reference vessel diameter ranging between 4.8–9.1 mm at the target lesion

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