InspireMD ( (NSPR) ) has issued an update.
InspireMD, Inc. has announced the submission of a Premarket Approval (PMA) application to the FDA for its CGuard Prime Carotid Stent System, following positive results from its C-GUARDIANS clinical trial. The trial showed a lower major adverse event rate than any previous trial of its kind, signifying a potential breakthrough in stroke prevention and carotid artery disease treatment. The company anticipates a U.S. commercial launch in the first half of 2025, pending approval.
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