InspireMD has been granted premarket approval (PMA) from the US Food and Drug Administration (FDA) for its CGuard Prime carotid stent system in the USA—news that follows the company’s recent announcement of CE-mark approval under the European Medical Device Regulation (MDR).
“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 USA with this device,” said Christopher Metzger (OhioHealth, Columbus, USA). “As US primary investigator for this pivotal IDE [investigational device exemption] trial, I am proud of the scientific rigour and integrity of the data, which demonstrate the lowest event rates—stroke, death and MI [myocardial infarction] to 30 days, and ipsilateral stroke at one year—ever reported in any trial of carotid revascularisation. 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 US patients with obstructive carotid artery disease, and continued benefits to patients worldwide.”
An InspireMD press release details that the US FDA’s PMA is backed by “best-in-class evidence” from the 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 USA 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 one-year (1.93%) primary endpoint major adverse event rates of any pivotal study of carotid intervention, the company claims.
InspireMD’s announcement of US FDA approval for the CGuard Prime carotid stent system triggers the second of four milestone-driven warrant tranches pursuant to the private placement financing of up to US$113.6 million announced by the company in May 2023. InspireMD says gross proceeds from this warrant tranche are expected to be US$17.9 million if exercised in full, and proceeds—if available—will be used to support the imminent commercial launch of the device in the USA, as well as initiating new regulatory pathways for advanced applications of the CGuard stent platform and developing new products.
In a separate press release announcing the CE-mark approval of CGuard Prime under the European MDR, InspireMD notes that development of the device incorporated extensive user feedback to optimise deliverability and deployment of the original CGuard stent. With its proprietary MicroNet mesh, CGuard is designed to reduce both early and late embolic events by trapping debris against the vessel wall, preventing plaque prolapse and embolisation that can potentially cause stroke, the release adds.
“Securing CE-mark certification under the EU MDR is a major milestone that demonstrates InspireMD’s commitment to advancing our next-generation platforms, regulatory rigour, and execution,” said Marvin Slosman, chief executive officer (CEO) of InspireMD. “This approval clears the path for the commercial launch of CGuard Prime EPS [embolic prevention system] across our current CE mark-served markets, taking a pivotal step forward in our growth as a commercial-stage company and further strengthening our leadership in carotid stenting innovation.”
