| InspireMD |
CGuard Prime
|
SmartFit auto-tapering |
30, 40 |
8, 9, 10 |
30, 40 |
Emboshield Nav 6 or Mo.Ma or both |
BareWire filter delivery wire (Nav6) or proximal embolic protection device (Mo.Ma) |
Distal (Nav6) or proximal (Mo.Ma) or both |
Used in conjunction with embolic protection devices specified in the labeling, is indicated for improving carotid luminal diameter in patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet both criteria outlined below: patients with neurological symptoms and ≥ 50% stenosis of the common or internal carotid artery by angiogram, or patients without neurological symptoms and ≥ 80% stenosis of the common or internal carotid artery by angiogram; patients having a vessel with reference diameters between 6.4 mm and 9 mm at the target lesion; the CGuard Prime Carotid Stent System should be used in conjunction with the Abbott Emboshield NAV6 Embolic Protection System or the Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device |