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]

报名：首届全球眼科大会 | 议程更新 报名：首届全球骨科大会 | 议程更新 报名：首届全球心血管大会 | 奖项申报 合作伙伴征集：2025全球手术机器人大会 2025年3月26日，NMPA公布了创新医疗器械特别审查申请审查结果公示（2025年第3号），有 14款 产品进入创新通道。其中包括， 上海申淇医疗科技有限公司 申 请的 抗栓塞脑保护装置 。 抗栓塞脑保护装置 （Cerebral Protection Devices, CPDs ）是专为降低经导管主动脉瓣置换术（Transcatheter Aortic Valve Replacement, TAVR ）过程中 脑卒 中 风险而设计的医疗器械。 # 研发背景 经导管主动脉瓣置换术（TAVR） 是一种用于治疗严重主动脉瓣狭窄的微创手术，手术过程中可能会有血栓或组织碎片脱落，随血流进入脑部，增加脑卒中的风 险。 脑卒中 是经导管主动脉瓣置换术（TAVR）最严重的并发症之一，显著增加患者神经认知功能下降及死亡的风险。随着TAVR适应证逐步扩展至外科低风险患 者群体，脑卒中的预防与治疗愈发重要。 TAVR术后卒中发生率 介于 1.7%-4.8% 之间， 无症状卒 ...