智通财经APP讯,沛嘉医疗-B(09996)发布公告,本公司近日已收到中国国家药品监督管理局(国家药监局)的确认函,确认其已受理GeminiOne® 经导管缘对缘修复(TEER)系统的注册申请。
GeminiOne®是本公司内部研发的创新TEER装置。其独特的滑槽式机械结构在保持较小植入物尺寸及输送系统的同时,实现了更长的夹合臂长。其他创新之处包括能够降低手术复杂性的独立瓣叶抓捕功能,可防止手术过程中的重复锁定及解锁的自动锁定机制及能够适应更广泛解剖结构的多角度解脱设计。
智通财经APP讯,沛嘉医疗-B(09996)发布公告,本公司近日已收到中国国家药品监督管理局(国家药监局)的确认函,确认其已受理GeminiOne® 经导管缘对缘修复(TEER)系统的注册申请。
GeminiOne®是本公司内部研发的创新TEER装置。其独特的滑槽式机械结构在保持较小植入物尺寸及输送系统的同时,实现了更长的夹合臂长。其他创新之处包括能够降低手术复杂性的独立瓣叶抓捕功能,可防止手术过程中的重复锁定及解锁的自动锁定机制及能够适应更广泛解剖结构的多角度解脱设计。
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