Indicated for use as a guidewire and EPS to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries; the diameter of the artery at the site of the filter basket placement should be from 3–7.5 mm (see instructions for use for basket/vessel sizing)
Cordis
Angioguard XP Emboli Capture Guidewire System
Filter
Distal
Indicated for use as a guidewire and EPS to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries; the diameter of the artery at the site of the filter basket placement should be from 3–7.5 mm (see instructions for use for basket/vessel sizing)
Abbott
Emboshield Nav6
Independently movable filter with BareWire filter delivery wire
Distal
Indicated for use as a guidewire and EPS to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries and while performing atherectomy, during standalone procedures or together with PTA and/or stenting, in lower extremity arteries; the diameter of the artery at the site of the filtration element placement should be between 2.5–7 mm
Boston Scientific Corporation
Enroute Transcarotid Neuroprotection System
Robust flow reversal
Proximal
Intended to provide transcarotid vascular access, introduction of diagnostic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis and who have the appropriate anatomy described below: adequate femoral venous access, common carotid artery reference diameter of at least 6 mm, carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex Doppler ultrasound or computerized axial tomography angiography or magnetic resonance angiography
Boston Scientific Corporation
FilterWire EZ Embolic Protection System
Filter
Distal
Indicated for use as a guidewire and EPS to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries; the diameter of the vessel at the site of filter loop placement should be between 2.25–5.5 mm for coronary saphenous vein bypass graft procedures and between 3.5–5.5 mm for carotid procedures
Medtronic
Mo.Ma Ultra Proximal Cerebral Protection Device
Proximal protection
Proximal
Indicated as an EPS to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures involving lesions of the internal carotid artery and/or the bifurcation; the reference diameter of the external carotid artery should be between 3–6 mm and the reference diameter of the common carotid artery should be between 5–13 mm
Indicated for use as a guidewire to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries; the diameter of the artery at the site of the filter placement should be between 3 and 6.5 mm
Contego Medical LLC
Neuroguard IEP System 3-in-1: stent + balloon + filter
Integrated embolic protection (IEP) filter
Distal
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 following criteria: 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; and patients with reference vessel diameters 4–8 mm; also indicated for postdilation 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
Indicated for percutaneous transluminal angioplasty (PTA) in the carotid arteries with capture and removal of embolic material; also indicated for postdilation of self-expanding stents in the carotid arteries with capture and removal of embolic material; the diameter of the arterial site for filter deployment should be no more than 7 mm; the Paladin Carotid PTA Balloon System with Integrated Embolic Protection (IEP) should always be used in conjunction with an available embolic protection device when used for postdilation of self-expanding stents
Medtronic
SpiderFX Embolic Protection Device
Filter; guidewire of choice
Distal
Lower extremity indication: indicated for use as a guidewire and EPS to contain and remove embolic material in conjunction with the TurboHawk, either during standalone procedures or together with PTA and/or stenting, in the treatment of severely calcified lesions in arteries of the lower extremities; the vessel diameter at the filter basket placement site should be between 3–6 mm; carotid indication: indicated for use as a guidewire and EPS to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries; the diameter of the artery at the site of the filter basket placement should be between 3–7 mm; saphenous vein graft indication: indicated for use as an EPS to contain and remove embolic material (thrombus/debris); the device also acts as the guidewire while performing PTCA or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3–6 mm
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