港股异动 | 健世科技-B(09877)涨超7% 经导管三尖瓣置换系统取得欧盟MDR CE认证

智通财经07-08

智通财经APP获悉，健世科技-B(09877)涨超7%，截至发稿，涨7.46%，报8.21港元，成交额125.77万港元。

消息面上，健世科技今早公布，近日，集团自主研发的经导管三尖瓣置换系统(Transvenous Tricuspid Valve Replacement System) LuX-Valve Plus取得欧盟MDR CE认证，达成公司国际化战略的重要里程碑。LuX-Valve系列产品此前已入选欧洲临床专家委员会科学建议试点、获得美国FDA突破性器械认定、获选加入FDA产品全生命周期咨询计划，并进入中国国家药监局(NMPA)创新医疗器械特别审查程序。

据悉，LuX-Valve系列产品已为全球五大洲数十个国家地区的超千例患者完成临床植入，积累了丰富的应用经验，弥补了大量三尖瓣反流尤其复杂解剖结构患者的临床治疗空白。公司表示正持续快速推进LuX-Valve Plus在欧洲以及全球的商业化进程，实现公司长期国际化战略目标。

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