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 obtained 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 - The TaurusTrio TAV system utilizes proprietary anchoring technology that allows for secure fixation even in the absence of calcified tissue, which is a common challenge in AR patients [1] - The system ensures proper alignment of the valve with the native leaflets, enhancing the effectiveness of the treatment [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 date of the announcement [1] - The successful launch of the TaurusTrio TAV system in China is expected to provide a safe and effective treatment option for patients suffering from severe AR, fulfilling a significant clinical demand in the market [1]
沛嘉医疗-B：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