GOOD SAMARITAN HOSPITAL MEDICAL CENTER

InspireMD Receives FDA Approval for CGUARDIANS III Pivotal Study of SwitchGuard Neuro Protection System

- The FDA has approved InspireMD's Investigational Device Exemption application to initiate the CGUARDIANS III pivotal study of its SwitchGuard neuro protection system for stroke prevention. - The study will evaluate next-generation enhancements to the SwitchGuard system for use with the CGuard Prime 80 cm stent platform in transcarotid artery revascularization procedures. - InspireMD targets a U.S. commercial launch of the SwitchGuard NPS in 2027, pending regulatory approval following successful completion of the pivotal trial. - The study will be led by the same investigators who conducted the previous CGUARDIANS II trial, ensuring continuity in clinical development.