健世科技-B(09877):JensClip已递交CE认证注册申请

智通财经
Dec 29, 2025

智通财经APP讯,健世科技-B(09877)发布公告,近日,公司经导管介入二尖瓣修复(TMVr)系统JensClip已正式递交CE认证注册申请,这是公司继经导管三尖瓣置换系统LuX-Valve Plus后,又一成功递交CE认证注册申请的产品,是公司国际化战略的重要进程。

JensClip是一款为治疗重度二尖瓣反流而设计的创新医疗器械,器械操作简便可靠。其爪楔式机械锁定设计,可实现任意角度锁定,确保瓣叶对合稳定可靠,预计可以有效改善二尖瓣反流、减少瓣叶张力。其菱形瓣膜夹设计,易于回收及重定位,跨瓣操作更安全,有效提高术式安全性以及操作便捷性;其一体式解离设计预计能降低分次解离过程中潜在的误操作风险,有效缩短器械操作时间。JensClip的创新设计已在全球进行了专利布局。

JensClip一年期临床随访结果和挑战病例应用经验已于2025年的EuroPCR、TCT San Francisco,以及PCR London Valves等国际学术会议上公布,其安全性指标和有效性指标均表现优异,获得广泛关注。

目前,JensClip在中国已完成国家药品监督管理局注册申请递交并且获得受理,一年期随访结果优异,正处于注册审评阶段。JensClip亦已顺利在海外开展临床应用。公司将积极推动该产品的注册进程,满足广泛的临床需求。

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