JenaValve的Trilogy™ THV系统已于2021年5月获得CE标志认证，且截至本公告日期，已在真实世界临 床实践中用于超过1000例商业化手术。本公司期待 TaurusTrio™ TAV系统于中国成功上市，预计将为患 有重度AR的中国患者提供安全有效的治疗选择，从而满足一项重大未满足的临床需求。 智通财经APP讯，沛嘉医疗-B(09996)发布公告，于2025年12月11日，本公司收到中华人民共和国国家药 品监督管理局就TaurusTrio™经导管主动脉瓣(TAV)系统的注册申请发出的批准。 兹提述本公司日期为2022年1月14日的公告。TaurusTrio™ TAV系统由本公司基于自JenaValve Technology, Inc.(JenaValve)获得的Trilogy™经导管心臟瓣膜(THV)系统的独占许可开发及制造。该系统 专为经股动脉通路治疗原生重度主动脉瓣反流(AR)患者而设计。与主动脉瓣狭窄患者不同，AR患者的 主动脉瓣通常缺乏钙化组织以供TAV锚定，令AR患者的治疗选择有限。该系统采用专有的定位键技 术，即使在不含钙化组织的情况下，亦可通过附着于原生瓣叶实现稳固锚定，同时确保瓣 ...

Core Insights - Ken-Valve, a transcatheter aortic valve replacement (TAVR) product developed by the company, has successfully completed its first commercial implants in key hospitals across China, marking a significant milestone in its commercialization process [1][2] - The product is designed to treat severe aortic regurgitation or combined aortic stenosis, addressing a critical clinical need in the market for TAVR products [1] - The design features of Ken-Valve, including a one-piece clamping positioning key and an active bending delivery system, enhance valve stability and coaxiality during implantation, catering to patients with complex anatomical structures [1] Market Strategy - The successful launch of Ken-Valve signifies the initiation and smooth advancement of its commercial application in China, prompting the company to expand its sales network and pursue global commercialization of its core products, including the Ken-Valve and LuX-Valve series [2] - The company aims to optimize production costs and operational efficiency to achieve its revenue targets as soon as feasible [2]