Tel Aviv, Israel, Miami, Florida - InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced the presentation of positive one-year outcomes from its C-GUARDIANS IDE clinical trial of the CGuard Carotid Stent System for the treatment of carotid artery stenosis at this year's Leipzig Interventional Course (LINC) 2024, which is being held May 28-31, in Leipzig, Germany.
Marvin Slosman, chief executive officer of InspireMD, stated, 'We are very pleased to have such a significant presence at this year's LINC conference, highlighted by a presentation of the primary endpoint results from our C-GUARDIANS clinical study. The independently adjudicated major adverse event rates through one-year are the lowest reported to date from any carotid stent or embolic protection device pivotal trial. With these data in-hand, we now have line of sight to a PMA application in the back half of this year, with preparation ongoing for a robust U.S. commercial launch in the first half of 2025, if approved. In addition to these results, we continue to be enthusiastic about our plans to introduce both CAS and TCAR solutions serving the broadest community of specialists serving the carotid revascularization market with the best implant in CGuard Prime.'
Dr. Chris Metzger, M.D., System Vascular Chief at OhioHealth, and lead investigator of the C-GUARDIANS trial, stated, 'We are very excited that the one-year carefully adjudicated C-GUARDIANS data confirm the extremely low rates of stoke, death, myocardial infarction, and target vessel revascularization in this prospective trial of high-carotid endarterectomy (CEA) risk patients with obstructive carotid disease, including 25% who were symptomatic. These data confirm the potential 'neuroprotective properties' of this unique MicroNet technology, offering an outstanding front-line option to consider for each patient with obstructive carotid artery disease.'
Presentation details
Title: One-Year Follow-Up Results from the C-GUARDIANS Pivotal Trial of the
CGuard Carotid Stent System
Presenter: Dr. D. Christopher Metzger, System Vascular Chief, OhioHealth
Date/time: Tuesday, May 28th at 2:53 pm CEST (8:53am EDT)
Presentation Highlights
From July 2021 to June 2023, 316 patients were prospectively enrolled in this single-arm carotid artery stenting study performed at 24 sites in the US and the EU.
The primary endpoint is a composite of: (1) incidence of major adverse events including death (all-cause mortality), any stroke, or myocardial infarction (DSMI) through 30-days post index procedure, or (2) ipsilateral stroke from day 31 to day 365 post-procedure.
Stenting with the CGuard carotid stent system in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a primary endpoint event rate of 1.95%, from procedure through 1-year follow-up.
About LINC
LINC, the Leipzig Interventional Course, is strongly committed to contributing to a systematic scientific evaluation and interdisciplinary discussion of new methods in the field of vascular medicine, allowing conclusions for daily interventional practice. LINC is an interdisciplinary live course, designed to provide a global platform, permitting the discussion of the 'vascular patients' by integrating colleagues of different specialties from around the world who are performing endovascular interventions.
About C-GUARDIANS
The C-GUARDIANS clinical trial evaluated the safety and efficacy of the CGuard Carotid Stent System for the treatment of carotid artery stenosis. The study enrolled 316 patients across 24 trial sites in the U.S. and Europe.
The trial included both symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS). The primary endpoint includes the composite of the following: incidence of the following major adverse events: death (all cause mortality), all stroke, or myocardial infarction (DSMI) through 30 days post index procedure, or ipsilateral stroke from 31 365-day follow up, based on the Clinical Events Committee (CEC) independent adjudication. The performance goal will be considered to have been met if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint rate is
INSPIREMD, INC. 
