Core Viewpoint - The company has submitted a CE mark registration application for its GeminiOne transcatheter edge-to-edge repair (TEER) system for treating mitral valve regurgitation, indicating steady progress in its global strategy [1] Group 1: Product Development - GeminiOne is an internally developed innovative TEER device featuring a unique sliding groove mechanical structure that maintains a small implant size and delivery system while achieving a longer grasping arm length [1] - The device includes innovative features such as an independent leaflet capture function to reduce surgical complexity, an automatic locking mechanism to prevent repeated locking and unlocking during the procedure, and a multi-angle release design to accommodate a wider range of anatomical structures [1] - The design of GeminiOne has been patented globally and has passed multiple freedom-to-operate analyses [1] Group 2: Regulatory Progress - As of the announcement date, the registration application for GeminiOne has been accepted by the National Medical Products Administration of the People's Republic of China and is currently under review [1] - Additionally, GeminiOne has received an investigational device exemption from the U.S. Food and Drug Administration to conduct early feasibility studies [1] - The company is actively advancing the registration process for this product in China and Europe, aiming to provide safe and effective treatment options for patients with mitral valve regurgitation as soon as possible [1]
沛嘉医疗-B：提交GeminiOne 经导管缘对缘修复系统的EU MDR CE标志注册申请