InspireMD’s CGuard Prime Achieves 100% Success in 30-Day TCAR Trial
NSPR•InspireMD’s CGUARDIANS II trial of the CGuard Prime 80 cm implant in 50 high-risk TCAR patients achieved 100% acute device success with zero deaths, strokes or stent thrombosis at 30 days. A PMA supplement is under FDA review with potential H2 2026 approval to address over 35,000 annual U.S. TCAR procedures.
1. CGUARDIANS II 30-Day Results
CGUARDIANS II evaluated the CGuard Prime 80 cm implant in 50 high-risk patients undergoing transcarotid artery revascularization, achieving 100% acute device success and zero deaths, strokes or stent thrombosis at 30 days. Complete stent patency was confirmed in all evaluable subjects.
2. Regulatory Pathway
InspireMD submitted a PMA supplement for the 80 cm CGuard Prime implant, currently under FDA review with a decision anticipated in the second half of 2026. Approval would extend the device’s indication from carotid artery stenting to TCAR procedures.
3. Market Implications
InspireMD aims to leverage its mesh technology and pending SwitchGuard neuroprotection system to capture a share of the more than 35,000 annual U.S. TCAR procedures. Approval of CGuard Prime 80 cm could establish the device as a standard implant for high-risk patients.
