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InspireMD Presents Positive 30-Day Follow-Up Results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) Clinical Trial at VIVA23
Data demonstrate a low major adverse event rate of 0.95% through 30 days post-procedure TEL AVIV, Israel and MIAMI, Nov. 01, 2023 (GLOBE NEWSWIRE) --
About this update from Inspiremd Inc.
[{"type":"text","content":"Data demonstrate a low major adverse event rate of 0.95% through 30 days post-procedure\nTEL AVIV, Israel and MIAMI, Nov. 01, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today presented 30-day results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) clinical trial at the Vascular InterVentional Advances (VIVA) meeting, which is being held October 30 through November 2 in Las Vegas, NV. The presentation, which was accepted as a late-breaking abstract, was delivered by Dr. Chris Metzger, System Vascular Chief at OhioHealth in Columbus, OH and principal investigator of the C-GUARDIANS trial. C-GUARDIANS is a pivotal trial designed to evaluate the safety and efficacy of the CGuard™ Carotid Stent System when used to treat symptomatic and asymptomatic carotid artery stenosis in patients undergoing carotid artery stenting (CAS) and at a high risk for carotid endarterectomy (CEA). 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 C-Guard carotid stent system in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a DSMI rate of 0.95%, from procedure through 30 days follow-up. Marvin Slosman, chief executive officer of InspireMD, stated, “The follow-up data from C-GUARDIANS once again supports the safety of the C-Guard EPS stent, with its novel MicroNet™ technology, as reflected in the low rate of major adverse events observed through 30 days. We believe the neuroprotective qualities of C-Guard set it apart from competing stents on the market and should help accelerate the ongoing shift in carotid revascularizations from ‘surgery first’ to an endovascular ‘stent first’ approach. We look forward to reporting 12-month results as we continue to advance CGuard EPS toward potential FDA approval in the first half of 2025.” InspireMD anticipates reporting primary endpoint results fr...