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创新速递
公司新闻 创新速递 媒体报道
TaurusTrio™经导管主动脉瓣置换系统多中心注册临床试验于中国进行首例患者植入
2023-08-01 10:28:23

2023年7月31日,沛嘉医疗-B(09996)发布公告,公司已就TaurusTrio™经导管主动脉瓣置换(TAVR)系统的多中心注册临床试验入组首例患者,该系统为JenaValve Technology, Inc.(JenaValve)所开发用于治疗主动脉瓣反流的经独占许可的Trilogy™心脏瓣膜系统。首例植入已于2023 年7月26日由吴永健教授及宋光远教授在首都医科大学附属北京安贞医院顺利完成。

该系统的注册临床试验是一项目标值法、前瞻性、多中心研究,旨在评估该系统治疗经心脏团队(包括心脏外科医生)评估为有高危或极高危的外科主动脉瓣置换风险的由原生瓣叶病变导致的有症状的重度主动脉瓣反流患者的安全性及有效性。该临床试验的结果将被纳入该公司未来向国家药品监督管理局提交的注册申请。

于2023年6月,该系统获正式纳入国家药监局创新医疗器械特别审批程序。截至本公告发布之日,中国尚未有经股主动脉瓣反流TAVR产品获国家药监局批准。



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