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国家药监局受理TaurusTrio经导管主动脉瓣系统的注册申请
2025-04-15 13:48:17

金沙检测线路js95-B(09996.HK)公告,于近日,公司收到中国国家药品监督管理局的受理通知书,确认受理TaurusTrio经导管主动脉瓣(TAV)系统的注册申请。

TaurusTrio TAV系统由公司基于自JenaValve Technology, Inc.获得的独占许可开发及制造,专为经股动脉通路治疗原生重度主动脉瓣反流患者而设计。该系统于2023年6月获国家药监局创新医疗器械特别审批程序受理,将于注册申请过程中优先评估及审批。



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