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]

Core Insights - The CREST-2 study demonstrated that carotid artery stenting combined with intensive medical therapy significantly reduces the risk of stroke compared to intensive medical therapy alone in patients with severe asymptomatic carotid stenosis [1][2][4] - The study results were presented at major medical conferences and published in the New England Journal of Medicine, marking a pivotal moment for the treatment of carotid disease [1][4] Study Details - CREST-2 was a NIH-sponsored clinical trial involving 155 centers globally, comparing outcomes of carotid artery stenting plus intensive medical management against intensive medical management alone [4] - The primary outcome measured was a composite of any stroke or death, assessed from randomization to 44 days, or ipsilateral ischemic stroke during the follow-up period of up to 4 years [4] - A total of 1245 patients were randomized in the stenting trial, while 1240 patients were randomized in the endarterectomy trial [4] Company Positioning - InspireMD's CGuard Prime carotid stent system is positioned as a leading option for carotid stenting, supported by the positive CREST-2 results and over 65,000 global implants [3][5] - The company emphasizes the effectiveness of its MicroNet™ mesh technology in achieving low adverse event rates, with a reported 1.93% major adverse event rate through 12 months in high surgical risk patients [3]