InspireMD announces FDA approval of IDE application for CGUARDIANS III study

InspireMD (NSPR) announced that the U.S. FDA has approved the company’s Investigational Device Exemption Application to initiate the CGUARDIANS III pivotal study of its SwitchGuard neuro protection system, including next generation enhancements from our prior IDE approval for use with its CGuard Prime 80 cm stent platform, in transcarotid artery revascularization procedures. “We look forward to the efficient execution of this important study as we target U.S. commercial launch of the SwitchGuard NPS in 2027, if approved.”