中国高端医疗器械创新再下一城 国内首款主动脉瓣反流介入瓣膜获批

Core Viewpoint - The J-Valve TF transcatheter aortic valve system, developed by Jiesheng Medical, has received approval from the National Medical Products Administration (NMPA) in China, offering a minimally invasive treatment option for millions of patients suffering from aortic regurgitation [1][2]. Company Overview - Jiesheng Medical, established in 2009, is one of the earliest companies in China to develop transcatheter aortic valve replacement (TAVR) products. Its first-generation product, J-Valve TA, was approved by NMPA in 2017 and has treated over ten thousand patients across nearly 200 major hospitals in China [2][3]. - The new J-Valve TF valve utilizes a femoral artery approach, allowing treatment for patients with various anatomical structures and reducing surgical trauma and recovery time [2][3]. Clinical Research and Market Potential - Clinical studies indicate that the J-Valve TF valve is particularly effective for treating non-calcified aortic regurgitation, with a significant clinical performance advantage [3]. - As of 2020, there were 20 million patients globally with aortic stenosis, with 4.4 million in China. By 2030, these numbers are expected to rise to over 23 million globally and 5.2 million in China. The prevalence of aortic regurgitation is comparable to that of aortic stenosis, indicating a substantial market opportunity for TAVR procedures in China, which currently has a low penetration rate of approximately 17,000 procedures annually [3]. International Recognition and Collaboration - Jiesheng Medical's innovative approach has gained international recognition, with Edwards Lifesciences acquiring overseas rights to the J-Valve valve, marking a significant milestone for Chinese medical devices in the global market [4]. - The J-Valve TF valve has shown promising results in early feasibility trials in the U.S., achieving a 93.3% procedural success rate and a 0% in-hospital mortality rate, leading to further clinical trials by Edwards in the U.S. [5]. Industry Insights - The medical device industry is characterized by high technical content, complex supply chains, and stringent regulatory oversight. The successful international expansion of the J-Valve valve demonstrates that innovative solutions addressing clinical needs can achieve global acceptance [6].