Core Viewpoint - The approval of the TaurusTrio transcatheter aortic valve (TAV) system by the National Medical Products Administration of China represents a significant advancement in treatment options for patients with severe aortic regurgitation (AR) [1][2] Group 1: Product Development and Approval - The TaurusTrio TAV system received approval on December 11, 2025, for its registration application [1] - The system is developed and manufactured by the company based on an exclusive license obtained from JenaValve Technology, Inc. for the Trilogy transcatheter heart valve (THV) system [1] - The TaurusTrio TAV system is specifically designed for treating patients with severe AR via the femoral artery approach, addressing a significant clinical need due to limited treatment options for AR patients [1] Group 2: Clinical Background and Market Potential - The Trilogy THV system, which serves as the basis for the TaurusTrio, received CE mark certification in May 2021 and has been used in over 1,000 commercial surgeries in real-world clinical practice as of the announcement date [2] - The company anticipates that the successful launch of the TaurusTrio TAV system in China will provide a safe and effective treatment option for patients suffering from severe AR, fulfilling a major unmet clinical demand [2]
沛嘉医疗-B(09996)：TaurusTrio?经导管主动脉瓣系统的注册申请获国家药品监督管理局批准