先健科技(01302)发布公告,于2025年2月8日,由中国医学科学院阜外医院舒畅教授领衔,与集团共同研发的主动脉覆膜支架系统获中国国家药品监督管理局正式注册批准。该产品为国家药品监督管理局批准的首款明确适用于烟囱技术的主动脉覆膜支架系统,为累及主动脉弓部病变的患者提供了一种操作简便、安全有效、解剖适应广泛的治疗新选择。
该产品由AnkuraTM Pro主动脉主体覆膜支架系统和LonguetteTM 主动脉分支覆膜支架系统组成。AnkuraTM Pro采用ePTFE 覆膜,并提供0-10多种锥度,可满足不同的临床需求。LonguetteTM裙边支架采用带外层裙边的双层结构设计,外层裙边可在支架释放后有效填补分支支架与主动脉支架的间隙,预期可以防止和减少内漏发生,降低并发症风险。三年随访结果显示,内漏发生率仅3.36%,远低于传统烟囱技术(10.7%~16.4%)。内层高密度镍钛合金骨架,近端加强段提供强径向支撑力,防止被主动脉支架压闭,确保分支血管远期通畅。术后一年随访分支血管通畅率97.87%,高于传统烟囱术式分支血管通畅率 (93%)。该产品操作便捷,安全高效,即刻技术成功率99.33%,术后一年夹层治疗成功率95.77%。
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