InspireMD’s CGuard Prime Carotid Stent System Approved by FDA

June 24, 2025—InspireMD, Inc. announced that the FDA has granted premarket approval (PMA) of the company’s CGuard Prime carotid stent system in the United States.

According to InspireMD, the PMA was backed by evidence from the company’s C-GUARDIANS pivotal investigational device exemption (IDE) trial, which demonstrated a primary endpoint of major adverse event rates of 0.95% at 30 days and 1.93% at 1 year. The study enrolled 316 patients at 24 sites in the United States and Europe to evaluate the safety and efficacy of CGuard Prime for treating carotid artery stenosis. The study’s findings were presented by D. Christopher Metzger, MD, at LINC 2024.

“The C-GUARDIANS clinical trial provides strong scientific evidence to support the neuroprotective benefits of the next-generation MicroNet mesh technology of the CGuard Prime carotid stent system, and results are consistent with the large body of evidence from outside of the United States with this device,” commented Dr. Metzger in the InspireMD press release. “As United States primary investigator for this pivotal IDE trial, I am proud of the scientific rigor and integrity of the data, which demonstrate the lowest event rates (stroke, death, and myocardial infarction to 30 days and ipsilateral stroke at 1 year) ever reported in any trial of carotid revascularization.”

Dr. Metzger continued, “These excellent results were in patients who were at high risk for carotid endarterectomy, a quarter of whom were symptomatic. CGuard Prime now offers an important frontline, proven technology for treatment of United States patients with obstructive carotid artery disease and continued benefits to patients worldwide.”

The FDA approval comes after InspireMD’s recent announcement of CE Mark approval under the European Medical Device Regulation for the CGuard Prime embolic protection system.