智通财经APP讯，沛嘉医疗-B(09996)发布公告，公司已于近日正式提交用于治疗二尖瓣反流的GeminiOne®经导管缘对缘修复(TEER)系统的 EU MDR CE标志注册申请，HighLife SAS为其欧洲合作伙伴。提交CE标志注册申请意味着公司在推进全球化战略方面取得稳步进展。
GeminiOne®是公司内部研发的创新TEER装置。其独特的滑槽式机械结构既保持较小植入物尺寸及输送系统，亦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。该系统的设计已于全球范围内申请专利，并已通过多项自由实施分析。
于本公告日期，GeminiOne®的注册申请已获中华人民共和国国家药品监督管理局受理，并正在审评中。此外，GeminiOne®已获美国食品药品监督管理局批准其临床试验用器械豁免，以开展早期可行性研究。公司将积极推进该产品于中国及欧洲的注册工作，致力于尽早为二尖瓣反流患者提供安全有效的治疗选择。
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