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先健科技(01302.HK):Yuranos™腹主动脉覆膜支架系统获得中国国药监局的注册批准

格隆汇 ·  {{timeTz}}

格隆汇11月24日丨先健科技(01302.HK)宣布,于2021年11月23日,集团自主研发的Yuranos腹主动脉覆膜支架系统"Yuranos"或"该器械")获中国国家药品监督管理局的注册批准。

Yuranos用于肾下型腹主动脉瘤的治疗。相较同类型产品,适用于临床中更复杂的瘤体形态,可满足更极限的临床解剖结构,具备更广泛的适应症:腹主动脉瘤近端最小瘤颈长度10mm,最大肾下成角75°。该器械为分体式设计,包含腹主动脉分叉支架系统和髂动脉延长支架系统。各系统均包含支架和输送器,支架由镍钛骨架和PET覆膜组成,每个支架装载在各自的输送器中,手术时分别由输送器输送和释放到预定位置。该器械同时具备独特设计,有效提升术中和远期治疗效果,降低手术并发症风险:i)腹主动脉分叉支架主体覆膜近端裸段倒刺和闭环mini支撑波设计,增加支架锚定性、贴壁性和柔顺性,有效防止移位和I型内漏;ii)髂动脉延长支架倒刺设计,增强组件间连接力,有效防止组件脱落导致的III型内漏;iii)输送器后释放功能配合支架组件锚定设计,实现精准定位和调控,进一步提升器械可用性和即刻手术成功率。

集团将继续坚持自主创新,携手业内专家推进创新医疗器械产品的研发和上市进程,造福广大患者。

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