InspireMD reports positive 30-day C-GUARDIANS trial results: 0.95% DSMI rate in 316 patients

InspireMD, Inc.

DSMI (death, stroke, MI) rate of 0.95% through 30 days post-procedure in 316 high-risk carotid artery stenosis patients.
Trial enrolled from July 2021 to June 2023 across 24 US and EU sites; single-arm, prospective IDE study.
Primary endpoint composite includes 30-day DSMI plus ipsilateral stroke from day 31 to 365; success if upper 95% CI < 11.6%.
Primary endpoint results expected H2 2024; potential FDA premarket approval application targeted for H1 2025.

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