InspireMD recently announced that the US Food and Drug Administration (FDA) has approved the company’s investigational device exemption (IDE) application to initiate the CGUARDIANS III pivotal study of its SwitchGuard neuro protection system (NPS) in transcarotid artery revascularisation (TCAR) procedures.
Patrick Geraghty (Washington University School of Medicine, St Louis, USA) and Patrick Muck (Good Samaritan Hospital, Cincinnati, USA), who previously led the CGUARDIANS II trial as co-lead investigators, will continue in the roles for the CGUARDIANS III trial.
“The approval of our CGUARDIANS III IDE represents a meaningful advancement in our quest to offer the full TCAR toolkit leveraging our best-in-class CGuard Prime 80cm stent platform for unmatched stroke prevention and carotid disease management,” said Marvin Slosman, CEO of InspireMD. “We look forward to the efficient execution of this important study as we target US commercial launch of the SwitchGuard NPS in 2027, if approved.”
