InspireMD wins US nod to extend CGuard Prime into TCAR procedures

InspireMD said on 12 November 2026 that the US Food and Drug Administration has cleared an expanded use for its CGuard Prime TransCarotid Stent System. The decision covers the 80 cm version of the delivery system and allows the stent to be used in transcarotid artery revascularisation (TCAR), alongside an embolic protection system that carries the appropriate labelling.

The company has not said what the decision could mean for sales, pricing or its competitive position, and the information available gives no launch date or reimbursement plan. Any commercial read-across therefore has to wait for further disclosure from InspireMD.

The label is narrow. It applies to patients judged to be at high risk from surgery who need carotid revascularisation. Use is also tied to a labelled embolic protection device, so the stent cannot be marketed as a standalone TCAR option.

The clinical case rests on CGUARDIANS II, a single-arm study of 50 patients. InspireMD reports that every acute device deployment succeeded, and that no patient had a death, stroke, myocardial infarction or stent thrombosis within 30 days. The study had no comparator group, and the data cited cover only the first month.

By way of context, a PMA supplement is the mechanism a manufacturer uses to change a device that already holds premarket approval, for example by adding an indication or altering the delivery system. That route lets a company build on an existing approval rather than file a new application.