FDA approves InspireMD's IDE for pivotal study of SwitchGuard neuro protection system in stroke prevention.

InspireMD announced that the FDA has approved its Investigational Device Exemption (IDE) application to start the CGUARDIANS III pivotal study for the SwitchGuard neuro protection system. This system, used with the CGuard Prime 80 cm stent, aims to improve stroke prevention during transcarotid artery revascularization (TCAR) procedures. The study is led by experienced vascular surgeons and targets a U.S. commercial launch in 2027, pending approval. This marks a significant step for InspireMD in advancing its carotid stent technology and expanding its stroke prevention tools.