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Trilogy™经导管心脏瓣膜(THV)系统
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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
智通财经网· 2025-12-11 09:32
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
智通财经网· 2025-12-11 09:22
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]