首个国家标准发布！经导管瓣膜行业将面临拐点

Core Viewpoint - The establishment of the national standard GB/T 12279.3-2025 for transcatheter aortic valve replacement (TAVR) products marks a significant step towards standardization in China's cardiovascular intervention market, enhancing product quality and regulatory clarity [4][6]. Industry Status: Technological Advances and Regulatory Gaps - TAVR has rapidly developed in China, with an expected patient population of 9.3 million by 2025 and projected TAVR procedures reaching 109,500 by 2030, reflecting a compound annual growth rate (CAGR) of 36.6% from 2021 to 2030 [2]. - The cardiovascular intervention market in China reached 50.1 billion yuan in 2023, with expectations to grow to 57 billion yuan by 2025, driven by aging demographics and increasing cardiovascular disease prevalence [2]. - The government is promoting high-value consumables procurement reforms, encouraging innovation and market access for new devices, which presents both challenges and opportunities for TAVR products [2][3]. Domestic Enterprises - Companies such as Qiming Medical, MicroPort, Lepu Medical, and Peijia Medical have achieved routine clinical use of their products, with an accelerated product launch pace since 2024, indicating a new phase of industry competition [3]. - Despite the rapid increase in product numbers, the industry faces challenges related to inconsistent performance metrics and a lack of systematic national standards, which affects clinician trust and product registration efficiency [3]. Standard Interpretation: Technical Content and Structure - The GB/T 12279.3-2025 standard encompasses design, manufacturing, preclinical evaluation, and labeling for all transcatheter heart valves, specifying performance requirements across various metrics [4][7]. - It includes testing methods and validation processes to ensure long-term product reliability and consistency, emphasizing risk management in product development [7]. Changes Brought by the New Standard - For physicians, the standard enhances confidence in product efficacy and safety [5]. - For enterprises, it provides clear technical specifications and compliance pathways, fostering a more structured development environment [5]. - For the industry, it promotes clearer market dynamics and accelerates standardized development [5][6]. Conclusion - The introduction of GB/T 12279.3-2025 signifies the formal entry of China's transcatheter valve sector into a standardized development phase, aiming to improve product quality, efficiency, and international competitiveness [6].