获批CE！新一代颈动脉支架系统

Core Insights - InspireMD has received CE approval for its next-generation carotid stent, CGuard Prime, which is designed to treat carotid artery stenosis [2][4][6] - The CGuard Prime stent utilizes unique MicroNet technology to effectively reduce the risk of embolic events and strokes [4][28] - The carotid stent market is projected to grow significantly, with a forecasted value of $1.2 billion in 2024, increasing to $2.5 billion by 2033, reflecting a compound annual growth rate (CAGR) of 9.2% from 2026 to 2033 [10][12] Company Overview - InspireMD was founded in 2005 and is headquartered in Tel Aviv, Israel, focusing on the development and commercialization of its core MicroNet technology for treating vascular diseases [30] - The company went public on NASDAQ in 2011 and aims to establish a unified platform for commercialization in the carotid stent market [6][30] Product Features - CGuard Prime features a dual-layer design and SmartFit technology, which enhances the stent's adaptability to various vascular shapes and sizes, thereby improving surgical outcomes and patient recovery [14][17][19] - The MicroNet technology, made from polyethylene terephthalate (PET), effectively intercepts thrombus and plaque while maintaining blood flow, contributing to the stent's efficacy [19][28] Clinical Trials - The C-GUARDIANS IDE study, a multi-center trial, aims to evaluate the safety and efficacy of the CGuard stent in high-risk patients, with results indicating a low adverse event rate of 1.95% within 12 months post-procedure [21][25][27] - The study supports the MicroNet's protective role against neurological events, demonstrating a 100% primary patency rate within six months and no in-stent restenosis [28]