InspireMD Announces Presentation of Positive One-Year Follow-Up Results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) Clinical Trial of CGuard at LINC 2024

Core Insights - InspireMD, Inc. announced positive one-year outcomes from the C-GUARDIANS IDE clinical trial for the CGuard™ Carotid Stent System, reporting the lowest primary endpoint event rate of 1.95% through twelve months post-procedure for any carotid stent or embolic protection device pivotal trial [1][2] - The company plans to submit a Premarket Approval (PMA) application to the FDA in the second half of 2024, with a U.S. commercial launch anticipated in the first half of 2025, pending approval [1][2] Clinical Trial Details - The C-GUARDIANS trial enrolled 316 patients across 24 sites in the U.S. and Europe from July 2021 to June 2023, focusing on patients with carotid artery stenosis at high risk for carotid endarterectomy [2][4] - The primary endpoint was a composite of major adverse events, including death, any stroke, or myocardial infarction through 30 days post-procedure, or ipsilateral stroke from day 31 to day 365 [5] - The trial confirmed extremely low rates of stroke, death, myocardial infarction, and target vessel revascularization, with 25% of participants being symptomatic [2][5] Technology and Market Position - InspireMD utilizes proprietary MicroNet® technology in its products, aiming to establish them as the industry standard for carotid stenting by providing superior acute results and durable, stroke-free long-term outcomes [6] - The company is enthusiastic about introducing both Carotid Artery Stenting (CAS) and Transcarotid Artery Revascularization (TCAR) solutions to serve a broad community of specialists in the carotid revascularization market [2]