智通财经APP讯,沛嘉医疗-B(09996)发布公告,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TaurusTrioTM 经导管主动脉瓣(TAV)系统的注册申请。
TaurusTrioTM 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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