先健科技:G-iliacTM Pro髂动脉覆膜支架系统获得中国国家药品监督管理局的正式注册批准

Core Viewpoint - The approval of the G-iliacTM Pro iliac artery covered stent system marks a significant advancement in the company's product offerings, enhancing solutions for endovascular treatment of iliac artery aneurysms and improving patient outcomes [1][3]. Group 1: Product Approval and Features - The G-iliacTM Pro received formal registration approval from the National Medical Products Administration of China on January 7, 2026, for the treatment of abdominal aortic aneurysms combined with iliac artery aneurysms [1]. - The product is designed to ensure pelvic blood supply by reconstructing the internal iliac artery, providing a more mature and comprehensive solution compared to existing treatment options [1]. - The G-iliacTM Pro consists of the G-iliacTM Pro covered stent and the SilverFlowTM Pro covered stent, featuring a low-profile delivery system and ergonomic design for improved usability and precision during procedures [2]. Group 2: Clinical Significance and Market Position - The G-iliacTM system, previously approved in 2021, was the first commercialized iliac artery bifurcation device in China, addressing a long-standing market gap in endovascular reconstruction of the internal iliac artery [2]. - Clinical applications and real-world studies have demonstrated the G-iliacTM's excellent safety, patency rates, and operational stability, enabling physicians to perform complex reconstructions more confidently [2]. - The company aims to provide a complete solution for minimally invasive treatment of aortic diseases, pushing towards a more systematic, standardized, and efficient development phase in the medical device sector [3].

LIFETECH SCI-先健科技:G-iliacTM Pro髂动脉覆膜支架系统获得中国国家药品监督管理局的正式注册批准 - Reportify