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US Device Guide / Embolic Protection Devices

Company Name Product Name Type Position US FDA Indicated Use
Cordis, a Cardinal Health company Angioguard RX 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)
Cordis, a Cardinal Health company 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; the diameter of the artery at the site of the filtration element placement should be between 2.5–7 mm
Silk Road Medical 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
Abbott RX Accunet Embolic Protection System Filter basket 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; the diameter of the artery at the site of filter basket placement should be between 3.25–7 mm
Boston Scientific Corporation Sentinel Cerebral Protection System Dual filter Utilizes a filter delivered to the brachiocephalic artery (proximal filter) and a second filter delivered to the left common carotid artery (distal filter) Indicated for use as an embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures; the diameters of the arteries at the site of filter placement should be between 9–15 mm for the brachiocephalic and 6.5–10 mm in the left common carotid
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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