江苏省1款第三类创新医疗器械获批上市

Core Viewpoint - Suzhou Jiecheng Medical Technology Co., Ltd.'s "Transcatheter Aortic Valve System" has received approval from the National Medical Products Administration for market launch, marking a significant advancement in innovative medical devices [1][4]. Company Summary - The "Transcatheter Aortic Valve System" is designed for trans-femoral access and features an active positioning clamp for native aortic valve leaflets, along with a bendable delivery system suitable for complex anatomical structures [4]. - This product is intended for patients over 70 years old who have symptomatic severe aortic regurgitation or aortic stenosis and are not suitable for conventional surgical valve replacement [4]. - The system consists of a transcatheter biological valve and a transcatheter delivery system, allowing for valve replacement through minimally invasive techniques without the need for open-heart surgery, significantly reducing surgical risks for elderly patients [4]. Industry Summary - The Jiangsu Provincial Medical Products Administration is implementing the national innovation-driven development strategy, focusing on optimizing the review and approval process for innovative medical devices [4]. - The administration aims to enhance the innovation service environment and improve pre-review mechanisms to address the challenges of long development cycles and high review requirements for Class III innovative medical devices [4]. - Emphasizing breakthroughs in core technologies and addressing critical technical challenges, the administration is committed to accelerating the market launch of innovative products and helping companies build competitive advantages in high-end medical devices [4].