Core Viewpoint - The company has received approval from the National Medical Products Administration of China for the registration of the TaurusTrio™ Transcatheter Aortic Valve (TAV) system, which is designed to treat patients with severe aortic regurgitation (AR) [1][2] Group 1: Product Development and Approval - The TaurusTrio™ TAV system is developed and manufactured based on an exclusive license obtained from JenaValve Technology, Inc. for the Trilogy™ Transcatheter Heart Valve (THV) system [1] - The approval date for the TaurusTrio™ TAV system is set for December 11, 2025 [1] - The system is specifically designed for treating patients with severe aortic regurgitation, which presents unique challenges compared to aortic stenosis patients [1] Group 2: Clinical Significance and Market Potential - The Trilogy™ THV system has 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 TaurusTrio™ TAV system will provide a safe and effective treatment option for patients with severe AR in China, addressing a significant unmet clinical need [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