USFDAMay 1, 2026, 04:06 PM
InspireMD gets FDA IDE approval for CGUARDIANS III TCAR study
AI Summary
InspireMD announced that the U.S. FDA has approved its Investigational Device Exemption (IDE) Application for the CGUARDIANS III pivotal study. This study will evaluate the company's SwitchGuard neuro protection system (NPS), including next-generation enhancements, for use with its CGuard Prime 80 cm stent platform in transcarotid artery revascularization (TCAR) procedures. The company aims for a U.S. commercial launch of the SwitchGuard NPS in 2027, if approved.
Key Highlights
- FDA approved InspireMD's Investigational Device Exemption (IDE) Application for the CGUARDIANS III pivotal study.
- The study will evaluate the SwitchGuard neuro protection system (NPS) with the CGuard Prime 80 cm stent platform.
- The system is intended for use in transcarotid artery revascularization (TCAR) procedures.
- Dr. Patrick Geraghty and Dr. Patrick Muck will continue as co-lead investigators for the CGUARDIANS III trial.
- InspireMD targets a U.S. commercial launch of the SwitchGuard NPS in 2027, pending approval.
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