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InspireMD Announces Publication of the C-GUARDIANS Pivotal Trial Manuscript in the Journal of the American College of Cardiology (JACC)
Globenewswire· 2026-01-12 14:00
Core Insights - The CGuard Prime Carotid Stent System has demonstrated the lowest 30-day and 1-year major adverse event rates in pivotal studies of carotid stenting [1][2][3] Group 1: Clinical Trial Results - The C-GUARDIANS pivotal trial published in the Journal of the American College of Cardiology (JACC) shows a 30-day disabling stroke or myocardial infarction (DSMI) rate of 0.95% and a one-year ipsilateral stroke rate of 1.93%, the lowest reported for high-risk patients [2][3] - The trial included 316 patients across 24 sites in the U.S. and Europe, with 25% of participants being symptomatic, indicating a favorable comparison to other carotid revascularization methods [4][2] - The primary endpoint of the trial was met, with the upper bound of the two-sided 95% confidence interval for the observed primary endpoint rate being less than 11.6% [4] Group 2: Technology and Market Position - The MicroNet™ technology used in the CGuard Prime is positioned as a potential next-generation standard of care for carotid artery stenting, expanding patient eligibility without compromising outcomes [3][4] - The publication in JACC is expected to enhance physician awareness and engagement, driving adoption of the CGuard Prime technology [3][4] - InspireMD aims to establish its MicroNet™ mesh technology as the industry standard for carotid stenting, focusing on achieving outstanding acute results and durable, stroke-free long-term outcomes [5]