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EUROPEAN 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 CE Mark Indications
Boston Scientific Corporation Carotid Wallstent Monorail 6, 8, 10 (unconstrained) 36, 48, 49, 59, 62 FilterWire EZ Embolic Protection System Filter Distal Used in conjunction with the Boston Scientific Embolic Protection System, it 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 of 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
MicroVention Terumo Casper RX In vivo tapering In vivo tapering 5–10 25, 37, 47; 22, 33, 40; 25, 35, 40; 25, 35, 40, 47; 33, 40; 35, 43 EmPro Embolic Protection System Dual-layer braided stent Sustained embolic protection Indicated for use in patients with carotid arterial atherosclerotic disease
InspireMD CGuard Embolic Protection System 6, 7, 8, 9, 10 20, 30, 40, 60 Compatible with both distal and proximal embolic protection devices Indicated for improving carotid luminal diameter in 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 either ultrasound or angiogram or patients without neurological symptoms and > 80% stenosis of the common or internal carotid artery by either ultrasound or angiogram; patients having a vessel with reference diameters between 4.8–9 mm at the target lesion
Balton Mer 7/5, 8/6, 9/7, 10/7, 10/8 20, 30, 40, 50 4, 5, 6, 7, 8, 9, 10 20, 30, 40, 50 Robin Filter Distal Carotid artery stenting
Cordis, a Cardinal Health company Precise Pro RX Carotid Stent System Autotapering 20, 30, 40 5–10 20, 30, 40 Angioguard RX Emboli Capture Guidewire Filter Distal 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 6–10 20, 30, 40, 60 SpiderFX Embolic Protection Device Filter; guidewire of choice Distal Indicated for treatment of stenoses of the common carotid artery, internal carotid artery, and carotid bifurcation
Terumo Europe Roadsaver Carotid Artery Stent 5–10 16–40 Nanoparasol Embolic Protection System Filter, concentric nitinol micromesh, guidewire of choice Distal Indicated for use in patients with carotid arterial atherosclerotic disease; indicated for use as a guidewire to contain and remove embolic material (thrombus/debris) while preforming angioplasty and stenting procedures in carotid arteries
Abbott RX Acculink Carotid Stent System 8/6, 10/7 30, 40 5–10 20, 30, 40 Emboshield Nav6 Embolic Protection Systems Filter; BareWire filter delivery wire Distal High surgical risk: used in conjunction with Abbott Vascular’s Accunet or Emboshield Family of EPSs, it is indicated for the 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 angiogram; patients without neurological symptoms and ≥ 80% stenosis of the common or internal carotid artery by ultrasound or angiogram; and patients must have a reference vessel diameter within the range of 4–9 mm at the target lesion
Abbott RX Acculink Carotid Stent System 8/6, 10/7 30, 40 5–10 20, 30, 40 RX Accunet Embolic Protection System Filter; fixed wire Distal High surgical risk: used in conjunction with Abbott Vascular’s Accunet or Emboshield Family of EPSs, it is indicated for the 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 angiogram; patients without neurological symptoms and ≥ 80% stenosis of the common or internal carotid artery by ultrasound or angiogram; and patients must have a reference vessel diameter within the range of 4–9 mm at the target lesion; Standard Surgical Risk: the RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular's Accunet or Emboshield Family of EPSs, is indicated for the treatment of patients at standard risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the following criteria: (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; (2) patients without neurological symptoms and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 60% stenosis of the common or internal carotid artery by angiogram; and (3) patients must have a reference vessel diameter within the range of 4–9 mm at the target lesion
BD Interventional Vivexx Carotid Stent 6/8, 7/10, 8/12 30, 40 5, 6, 7, 8, 9, 10, 12 20, 30, 40 Indicated for the treatment of patients with clinically significant carotid artery stenosis
Abbott X.Act Carotid Stent System 8/6, 9/7, 10/8 30, 40 7–10 20, 30 Emboshield Nav6 Embolic Protection System Filter; BareWire filter delivery wire Distal Used in conjunction with the Emboshield Embolic Protection System, it 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 following criteria: 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 intra-cranial 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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