InspireMD announced that the FDA has granted premarket approval (PMA) for its CGuard Prime carotid stent system, designed to prevent stroke through embolic protection. The Miami-based company recently secured CE mark approval as well.
The CGuard Prime builds on the original design with enhanced deliverability and deployment, featuring the proprietary MicroNet technology that traps embolic debris to reduce stroke risk and prevent plaque prolapse.
Supporting data from the C-GUARDIANS pivotal trial—enrolling 316 patients across 24 sites in the U.S. and Europe—demonstrated outstanding safety and efficacy, with the lowest 30-day (0.95%) and 1-year (1.93%) major adverse event rates reported in carotid intervention studies.
This FDA approval triggers the second tranche of milestone-driven warrants tied to a $113.6 million financing round announced in May 2023, potentially generating $17.9 million for InspireMD. Proceeds will support the U.S. launch of CGuard Prime, new regulatory efforts, product development, and international growth.
Marvin Slosman, CEO of InspireMD, called the approval a pivotal breakthrough in minimally invasive carotid artery revascularization, emphasizing the company’s commitment to rapid market introduction and broad patient access.
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