InspireMD Receives FDA Approval for CGuard Prime Stent System for TCAR Procedures

InspireMD, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its Premarket Approval Supplement for the CGuard Prime TransCarotid Stent System for use in transcarotid artery revascularization (TCAR) procedures. This approval is a significant milestone, expected to double the CGuard Prime platform's total addressable market in the U.S. by adding access to over 35,000 TCAR procedures annually. The approval was supported by data from the CGUARDIANS II pivotal trial, which demonstrated 100% acute device success and zero adverse events at 30 days.