最新数据！中国首款“一字型”二尖瓣夹

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].