大会进行时：首届全球骨科大会 | 参会须知 报名：首届全球心血管大会 | 重磅亮点 合作伙伴征集：2025全球手术机器人大会 心未来 2025 年 4 月 19 日， 由 杭州端佑医疗科技有限公司 （ 臻亿医疗 的全资子公司） 自主研发 的 中 国首款 "一字型"二尖瓣夹 NeoNova ® 的 1 年临床试验数据在杭州发布。 该研究 由厦门大学附属心血管病医院王焱教授 和 华中科技大学同济医学院附属协和医院董念国教授 牵头，结果显示 NeoNova ® 系统在治疗外科手术高危的 退行性二尖瓣反流患者 中表现出卓越的安 全性和有效性 。 NeoNova ® 关键性试验是一项前瞻性、单臂、多中心研究，旨在评估 NeoNova ® 系统在 中 重 度或重 度器质性二尖瓣反流患者 治疗中的安全性和有效性 ，注册号为 ChiCTR2200060182 。 研究设计 本研究在 中国 23 个研究中心 进行，于 2022 年 4 月 26 日启动， 2024 年 3 月 21 日完成，共纳入 123 名患者。 主要疗效终点（复合终点） 设定为术后 1 年治疗成功率：术后 1 年随访时无死亡、无因二尖瓣功能障碍 导致的外科 ...

Core Viewpoint - The article highlights the successful clinical trial results of the NeoNova® mitral valve clip system, demonstrating its safety and efficacy in treating high-risk patients with degenerative mitral regurgitation [1][3][9]. Research Design - The NeoNova® pivotal trial is a prospective, single-arm, multi-center study conducted across 23 research centers in China, starting on April 26, 2022, and completing on March 21, 2024, with a total of 123 patients enrolled [4]. Efficacy and Safety Outcomes - The primary efficacy endpoint, defined as the treatment success rate at one year post-operation, was achieved with a rate of 92.68%, with 79.66% of patients showing MR ≤ 1+ and 96.62% showing MR ≤ 2+ [9]. - The safety profile indicated a major adverse event (MAE) rate of 9.76%, an all-cause mortality rate of 2.44%, and a cardiac mortality rate of 0.81% at one year post-operation [9]. Background on Mitral Regurgitation - Mitral regurgitation (MR) is a common heart valve disease in an aging population, with a 5-year mortality rate of 50% for untreated severe cases [10]. - In the U.S., the prevalence of MR is 1.7%, with approximately 4.1 million cases, of which 1.67 million require surgical intervention. In China, the number of patients with moderate to severe MR increased from 10 million in 2017 to 11.1 million in 2021, with a projected growth to 12.6 million by 2027 [12]. Treatment Landscape - The traditional treatment for MR involves surgical valve replacement, but only 2% of moderate to severe MR patients undergo surgery due to the high risks associated with open-heart procedures [13]. - A minimally invasive approach, Transcatheter Edge-to-Edge Repair (TEER), has gained traction, allowing for reduced trauma and quicker recovery [17]. About NeoNova® Mitral Valve Clip System - The NeoNova® system is designed for treating moderate to severe degenerative mitral regurgitation, particularly in patients who are at high surgical risk. It utilizes TEER to reduce regurgitation and improve cardiac function [20]. - The system received approval from the National Medical Products Administration (NMPA) in China on February 8, 2025 [21]. Company Overview - Jiangsu Zhenyi Medical Technology Co., Ltd. (Zhenyi Medical) was established in July 2019 and focuses on developing and manufacturing products for structural heart disease, including valves and devices for heart failure [23]. - The company has completed multiple rounds of financing, indicating strong investor confidence and support for its innovative solutions in cardiovascular disease treatment [28][31].