InspireMD Receives FDA Approval for CGuard Prime Carotid Stent System with Record-Low Stroke Rates
核心洞察
InspireMD's CGuard Prime Carotid Stent System (搜索) received FDA premarket approval based on the C-GUARDIANS pivotal trial showing the lowest 30-day (0.95%) and 1-year (1.93%) major adverse event rates of any carotid intervention study.
The device features proprietary MicroNet mesh technology that combines the largest open-cell frame with the smallest mesh pore size to prevent plaque protrusion and provide sustained embolic protection beyond five years.
The approval triggers a $17.9 million warrant tranche from InspireMD's $113.6 million financing agreement and enables immediate commercial launch in the United States following prior CE Mark approval in Europe.
InspireMD has achieved a significant regulatory milestone with the U.S. Food and Drug Administration's premarket application (PMA) approval of its CGuard Prime Carotid Stent System (搜索) for stroke (搜索) prevention. The approval, announced on June 24, 2025, is supported by clinical data from the C-GUARDIANS pivotal trial demonstrating the lowest major adverse event rates ever reported in carotid intervention studies.
Clinical Trial Results Set New Safety Standard
The C-GUARDIANS clinical trial, 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 (搜索). The study achieved remarkable results with a 30-day major adverse event rate of just 0.95% and a 1-year rate of 1.93%, representing the lowest primary endpoint 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 (搜索)," said Dr. D. Chris Metzger, System Vascular Chief at OhioHealth and U.S. Primary Investigator for the pivotal trial. "These excellent results were in patients who were at high risk for carotid endarterectomy, a quarter of whom were symptomatic."
The trial's primary endpoint included the composite incidence of death (all-cause mortality), all stroke (搜索), or myocardial infarction (搜索) through 30 days post-procedure, plus ipsilateral stroke from 31-365 day follow-up. The performance goal was met with the upper bound of the two-sided 95% confidence interval below 11.6% and p-value less than 0.025.
Innovative MicroNet Technology Platform
The CGuard Prime Carotid Stent System (搜索) incorporates InspireMD's proprietary MicroNet mesh technology, designed to provide sustained embolic protection by preventing plaque protrusion through the stent. The device combines the largest open-cell frame of available carotid stents with the smallest mesh pore size, creating a barrier that traps debris against the vessel wall and prevents embolization that can cause stroke (搜索).
CGuard Prime was developed incorporating extensive user feedback and optimizes deliverability and deployment of the proven CGuard stent platform. The system has demonstrated lasting embolic protection beyond five years, with over 65,000 implants sold to date and studies conducted in over 2,000 patients.
Commercial Launch and Financial Impact
The FDA approval triggers the second of four milestone-driven warrant tranches from InspireMD's private placement financing of up to $113.6 million announced in May 2023. Gross proceeds from this warrant tranche are expected to be $17.9 million if exercised in full by warrant holders including Marshall Wace (搜索), OrbiMed (搜索), Rosalind, Nantahala, Soleus, Velan, and certain InspireMD Board members.
"I am proud to announce the PMA approval of CGuard Prime, our best-in-class carotid stent system," said Marvin Slosman, Chief Executive Officer of InspireMD. "The significance of CGuard Prime to the shift toward less invasive carotid artery (搜索) revascularization is tremendous. We look forward to making this technology available to all who can benefit with an immediate and aggressive U.S. launch."
Regulatory Pathway and Market Access
Prior to the FDA approval, InspireMD received CE Mark approval under the European Medical Device Regulation (MDR) for CGuard Prime EPS on June 13, 2025. This European approval cleared the path for commercial launch across InspireMD's current CE marked served markets and represents the same platform now approved for the United States market.
The dual regulatory approvals enable InspireMD to offer a unified platform across its served markets, providing greater scale as the company transitions to a commercial-stage operation. Proceeds from the warrant exercise will support the U.S. commercial launch, initiate new regulatory pathways for advanced applications of the CGuard stent platform, and fund development of new products while continuing international business development.