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EUROPEAN Device Guide / Embolic Protection Devices

Company Name Product Name Type Position CE Mark Indications
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 to 7.5 mm (see instructions for use for basket/vessel sizing)
Straub Medical AG Capturex Nitinol filter basket Proximal Indicated for the filtering of emboli from blood vessels during potentially embolizing procedures; peri-interventionally placed in the vascular system through a 10-F sheath; with the filter basket open it provides a 6-F working channel inside the catheter; target vessel diameter is 20–30 mm, maximum expansion of the filter basket is 40 mm
Abbott Emboshield Nav6 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
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
Invamed Inca Protective filter Distal Indicated for use as a guidewire and EPS to contain and remove embolic material while performing DVT carotid artery angioplasty, stenting procedures in carotid arteries; suitable for acute PE, VTE, and ICU thrombectomy
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
Terumo Europe Nanoparasol 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 performing angioplasty and stenting procedures in carotid arteries
Contego Medical LLC Paladin Carotid Post-Dilation Balloon System With Integrated Embolic Protection Carotid postdilation balloon with integrated embolic protection filter (40 µm) Distal Indicated for postdilation of a deployed self-expanding stent in the carotid artery
Balton Robin RX/OTW Nitinol filter basket Distal Distal neuroprotection system is used to seize embolic material during performance of angioplasty procedure on carotid artery and during stent implementation in carotid arteries; recommended vessel diameter from 3 to 7.5 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 an embolic filter delivered to the brachiocephalic artery (proximal filter) and a second embolic filter delivered to the left common carotid artery (distal filter) Indicated for use as an embolic protection device to capture and remove embolic material (thrombus/debris) that may enter the cerebral vascular system during endovascular 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 Indicated for distal embolization protection during general vascular use, including peripheral, coronary, and carotid interventions; indications, contraindications, warnings, and Instructions for Use can be found in the product labeling supplied with each device
Contego Medical LLC Vanguard IEP Peripheral Balloon Angioplasty System With Integrated Embolic Protection Angioplasty balloon with integrated embolic protection filter (150 µm) Distal Indicated for peripheral vascular percutaneous transluminal angioplasty and the capture and removal of embolic material during angioplasty for the femoral, iliac, popliteal, and profunda arteries

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