徐亚鹏,王海山,杨夏燕,秦涛,虞奇峰,温贤涛,杨剑

• 1:上海纽脉医疗科技股份有限公司
• 2:中国人民解放军空军军医大学第一附属医院心血管外科

摘要(Abstract)：

二尖瓣反流（M R）是最常见的心脏瓣膜疾病之一，经导管二尖瓣置换术（TMVR）逐步成为治疗MR的重要研究及发展方向。本文综述了TMVR产品研发及临床研究的最新进展，对多款国内外TMVR产品设计特点进行比较分析，概括了TMVR产品设计开发时需要考虑的重点与难点，如稳固锚定、减少瓣周漏、避免流出道梗阻和减小输送外径等；同时介绍了多款TMVR产品临床试验设计及阶段性进展，从器械手术成功率、全因死亡率、严重不良事件等方面比较各款产品的临床结果，分析TMVR产品存在的主要临床风险。最后对TMVR产品优化方向和应用前景进行了展望。

关键词(KeyWords)： 经导管二尖瓣置换术;设计研发;临床研究

Abstract:

Keywords:

基金项目(Foundation): 国家重点研发计划项目（2020YFC2008100）;; 浦东区科技发展基金项目（PKX2019-S14）;; 陕西省创新能力支撑计划-科技创新团队项目（2020TD-034）

作者(Author): 徐亚鹏,王海山,杨夏燕,秦涛,虞奇峰,温贤涛,杨剑

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