CGuard® is CE MDR Approved
CGuard® has not received approval from the U.S. Food and Drug Administration (FDA) for commercial use in the United States.
The CGuard® EPS 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 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 mm and 9.0 mm at the
target
lesion.
The following accessories are compatible with the CGuard® Embolic Prevention System:
- Proximal protective device Inner Diameter ≥2.12mm or ≥0.083" (for example 9F Mo.Ma™
ultra by
Medtronic), or comparable.
- Distal protection device Emboshield™ NAV6 by Abbot Cardiovascular, or comparable.
CGuard® and the InspireMD Logo are registered trademarks of
InspireMD, Inc.
Abbott® and Emboshield NAV6™ are registered trademarks of
Abbott Laboratories.
Medtronic® and Mo.Ma™ are registered trademarks of Medtronic
Corporation.
The CGuard Prime TransCarotid Stent System, when used in conjunction with an embolic protection
system 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 the 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 6.4mm and 9.0mm at the target
lesion.
- A carotid bifurcation location that is at least 5 cm above the clavicle, verified through
duplex Doppler ultrasound, computer tomography (CT) angiography, or magnetic resonance (MR)
angiography.
Compatible Embolic Protection Systems: ENROUTE™ Transcarotid Neuroprotection System.
ENROUTE™ is a registered trademark of Boston Scientific Corporation.
* Among commercially available carotid stents. Data on file.
** Defense is defined as the absence of restenosis
† Myocardial Infarction
‡ Based on modified intent-to-treat Kaplan-Meier analysis
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10.1007/s00270-025-04003-z.
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- U.S. Food and Drug Administration SSED: CGuard Prime Carotid Stent System (PMA P240029-S005) 2026.