其中包括 上海以心医疗器械有限公司 （简称" 以心医疗 "）申请的 经导管主动脉瓣系统（TAVR） 。 # 研发背景 主动脉瓣疾病是心血管疾病中的常见问题之一，其发病率随着年龄的增长而显著升高。 招商通知： 2025年9月4-5日，第三届全球手术机器人大会 个人奖项： 个人奖项，机会难得！医生、企业家、科研大咖，快来报名 企业奖项： 奖项申报！即将截止！第三届全球手术机器人大会 心未来 今日，NMPA公布了创新医疗器械特别审查申请审查结果公示（2025年第7号），有 10款产品 进入创新 通道。 流行病学研究显示， 主动脉瓣狭窄（AS） 是 65岁以上老年人 最常发生的心脏瓣膜病。中国老年心脏瓣 膜病队列研究（China-DVD）表明，60岁以上中度及以上瓣膜性心脏病的患者中，AS约占11.5%，超过 半数的老年主动脉瓣疾病是由 瓣膜退行性病变 引起的。 随着人口老龄化的加剧，预计到2025年，中国将有 约930万主动脉瓣狭窄或反流 患者，这无疑给公共卫 生带来了严峻挑战。 传统外科主动脉瓣置换术（SAVR） 是治疗主动脉瓣疾病的主要方法，但该手术创伤较大，对于高龄、合 并多种疾病或身体虚弱的患者风险较高。 ...

Core Viewpoint - The article highlights the successful commercialization and clinical application of the ScienCrown transcatheter aortic valve replacement (TAVR) system developed by Lepu Medical Technology, marking a significant advancement in the treatment of aortic stenosis patients in China [2][5][10]. Company Overview - Lepu Medical Technology (Shanghai) Co., Ltd. is a leading innovator in the field of interventional medical devices for structural heart diseases, supported by the Shanghai Biomedical Investment Fund. The company went public on November 8, 2022, on the Hong Kong Stock Exchange under the stock code 02291.HK [17]. - The company focuses on the research, development, production, and marketing of interventional medical devices, with over 40 products listed and in development, covering congenital heart disease, stroke prevention, and valve treatment solutions [17]. Product Introduction - The ScienCrown TAVR system is the world's first and only self-expanding short valve product with balloon-expandable advantages, designed to address existing challenges in TAVR procedures [4][12]. - The product features 100% full release and retrieval capabilities, dual access routes, and innovative designs that significantly enhance clinical practice [4][12][15]. Clinical Application - The first commercial implantations of the ScienCrown valve have been successfully conducted in multiple clinical centers across China, demonstrating its effectiveness and safety [5][7]. - Clinical trial results indicate a procedural success rate of approximately 99.2% and a device success rate of about 98.4%, with low rates of paravalvular leak and no severe leaks reported [7][10]. Market Context - Aortic valve disease, particularly aortic stenosis (AS), is a common cardiovascular issue, especially among the elderly, with a prevalence of approximately 11.5% in patients over 60 years old [8][10]. - The number of patients with aortic stenosis and aortic regurgitation in China is projected to reach 9.3 million by 2025, with a compound annual growth rate of 2.6% from 2022 to 2025 [10].