Core Insights - The company announced the approval of the TaurusTrio™ transcatheter aortic valve (TAV) system by the National Medical Products Administration of China, effective December 11, 2025 [1] - The TaurusTrio™ TAV system is developed under an exclusive license from JenaValve Technology, Inc. and is designed specifically for treating patients with severe aortic regurgitation (AR) [1][2] - The system utilizes proprietary anchoring technology to ensure stable fixation even in the absence of calcified tissue, addressing a significant unmet clinical need for AR patients [1] Group 1 - The TaurusTrio™ TAV system is intended for patients with severe aortic regurgitation, which presents different challenges compared to aortic stenosis patients [1] - The JenaValve Trilogy™ THV system, which the TaurusTrio™ is based on, received CE mark certification in May 2021 and has been used in over 1,000 commercial procedures [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 [2]
沛嘉医疗-B(09996.HK)：国家药监局批准TaurusTrio™经导管主动脉瓣系统的注册申请