Clinical TrialJun 11, 2026, 08:12 AM
InspireMD CGUARDIANS II Trial: 100% Acute Device Success for CGuard Prime
AI Summary
InspireMD announced positive 30-day outcomes from its CGUARDIANS II clinical trial for the CGuard Prime 80 cm implant, intended for transcarotid artery revascularization (TCAR) procedures. The trial demonstrated 100% acute device success with no deaths, strokes, myocardial infarctions, or stent thrombosis reported within 30 days. A Premarket Approval (PMA) supplement is currently under FDA review, with potential approval in the second half of 2026, which could significantly expand the company's addressable market to include TCAR procedures.
Key Highlights
- Acute device success achieved in 100% (50/50) of patients in the CGUARDIANS II trial.
- No deaths, strokes, or myocardial infarctions were reported within 30 days.
- No stent thrombosis was observed within 30 days.
- Complete stent patency observed at 30 days in evaluable subjects.
- PMA supplement for CGuard Prime 80 cm implant is under FDA review.
- Potential FDA approval anticipated in the second half of 2026.
- Aims to expand market to include over 35,000 TCAR procedures performed annually in the U.S.
Price Impact
More from NSPR