Core Viewpoint - The company has received confirmation from the National Medical Products Administration of China regarding the acceptance of its registration application for the GeminiOne® Transcatheter Edge-to-Edge Repair (TEER) system [1] Company Summary - GeminiOne® is an innovative TEER device developed in-house by the company [1] - The device features a unique sliding groove mechanical structure that maintains a smaller implant size and delivery system while achieving a longer grasping arm length [1] - Additional innovations include an independent leaflet capture function that reduces surgical complexity, an automatic locking mechanism to prevent repeated locking and unlocking during the procedure, and a multi-angle release design that accommodates a wider range of anatomical structures [1]
沛嘉医疗-B(09996):国家药监局受理GeminiOne经导管缘对缘修复系统的注册申请