Core Viewpoint - The company has received approval from the National Medical Products Administration of the People's Republic of China for the registration application of the TaurusTrio™ Transcatheter Aortic Valve (TAV) system, which is designed to treat patients with severe aortic regurgitation (AR) [1] Group 1: Product Development and Approval - The TaurusTrio™ TAV system is developed and manufactured based on an exclusive license from JenaValve Technology, Inc. for the Trilogy™ Transcatheter Heart Valve (THV) system [1] - The system is specifically designed for treating patients with severe aortic regurgitation via the transfemoral approach, addressing a significant unmet clinical need [1] Group 2: Technical Features - Unlike patients with aortic stenosis, AR patients typically lack calcified tissue for TAV anchoring, which limits treatment options [1] - The system utilizes proprietary positioning key technology to achieve stable anchoring even in the absence of calcified tissue, ensuring proper alignment of the valve [1] Group 3: Market Potential - The Trilogy™ THV system received CE mark certification in May 2021 and has been used in over 1,000 commercial procedures in real-world clinical practice as of the announcement date [1] - The company anticipates that the successful launch of the TaurusTrio™ TAV system in China will provide a safe and effective treatment option for patients with severe AR [1]
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