Clinical TrialJun 8, 2026, 08:02 AM
InspireMD enrolls first patient in CGUARDIANS III pivotal study
AI Summary
InspireMD announced the enrollment of the first patient in its CGUARDIANS III pivotal study for the SwitchGuard neuro protection system (NPS). This study evaluates the safety and efficacy of SwitchGuard NPS, used with the CGuard Prime 80 cm stent platform, in transcarotid artery revascularization (TCAR) procedures. The company aims to capture a share of the estimated 70,000 TCAR procedures expected annually in the U.S. by 2030, with the SwitchGuard NPS potentially setting a new standard of care.
Key Highlights
- First patient enrolled in CGUARDIANS III pivotal study for SwitchGuard neuro protection system.
- Study evaluates SwitchGuard NPS with CGuard Prime 80 cm stent for TCAR procedures.
- CGUARDIANS III is a prospective, multi-center, single-arm pivotal study.
- Approximately 103 subjects will be enrolled in the study.
- Aims to address an estimated 70,000 TCAR procedures annually in the U.S. by 2030.
- Dr. Patrick Muck and Dr. Patrick Geraghty are global co-principal investigators.
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