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September 16, 2024
InspireMD Seeks FDA Approval for CGuard Prime Carotid Stent System
September 16, 2024—InspireMD, Inc., developer of the CGuard embolic prevention stent system for the prevention of stroke, announced that it has submitted a premarket approval (PMA) application to the FDA seeking marketing approval for the CGuard Prime carotid stent system in the United States.
According to the company, the PMA application is based on the positive 1-year data from the C-GUARDIANS pivotal clinical trial that were presented at LINC 2024, the Leipzig Interventional Course held May 28-31 in Leipzig, Germany.
InspireMD’s C-GUARDIANS trial evaluated the safety and efficacy of CGuard for the treatment of carotid artery stenosis. The study enrolled 316 patients across 24 trial sites in the United States and Europe. The results showed a primary endpoint of major adverse event rate of 1.95% through 12 months post procedure, stated the company.
The press release noted that if PMA approval is received from the FDA, the company anticipates a commercial launch of the device in the first half of 2025.
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