InspireMD Announces FDA Approval for CGuard Prime Carotid Stent System for the Prevention of Stroke

MIAMI, June 24, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (the “Company”) (Nasdaq: NSPR), developer of the CGuard Prime Carotid Stent System for the prevention of stroke, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket application (PMA) approval of the CGuard Prime Carotid Stent System in the United States.

The PMA approval is backed by best-in-class evidence from the Company’s C-GUARDIANS pivotal trial, first presented at the Leipzig Interventional Course (LINC) in May 2024. The study, which enrolled 316 patients across 24 sites in the United States and Europe, evaluated the safety and efficacy of CGuard Prime for treating carotid artery stenosis. CGuard Prime demonstrated the lowest 30-day (0.95%) and 1-year (1.93%) primary endpoint major adverse event rates of any pivotal study of carotid intervention.

“The C-GUARDIANS clinical trial provides strong scientific evidence to support the neuro-protective 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,” said Dr. D. Chris Metzger, System Vascular Chief at OhioHealth. “As U.S. Primary Investigator for this pivotal IDE trial, I am proud of the scientific rigor and integrity of the data, which demonstrates the lowest event rates (stroke, death and MI to 30 days and ipsilateral stroke at 1 year) ever reported in any trial of carotid revascularization. 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.”

“I am proud to announce the PMA approval of CGuard Prime, our best-in-class carotid stent system. This is a pivotal milestone for the Company after many years of commitment to bringing this innovative stent platform to patients in the United States,” said Marvin Slosman, Chief Executive Officer of InspireMD. “The significance of CGuard Prime to the shift toward less invasive carotid artery revascularization is tremendous. Our approval marks a true breakthrough in the treatment of carotid disease. Our innovation is built around the protective MicroNet mesh barrier providing durable protection and preventing post procedural events, a unique and next generation advancement in the carotid field. With over 65,000 implants sold to date and studies in over 2,000 patients, CGuard Prime offers an established and tested advancement to patient care. We are grateful to the many who have contributed to this approval, including all of our trial investigators and investors. We look forward to making this technology available to all who can benefit with an immediate and aggressive U.S. launch.”