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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
Zhi Tong Cai Jing· 2026-01-08 11:25
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].
先健科技(01302) - 自愿性公佈 - G-iliac TM Pro髂动脉覆膜支架系统获得中国国...
2026-01-08 11:13
(股份代號:1302) 自願性公佈 香港交易及結算所有限公司與香港聯合交易所有限公司對本公佈的內容概不負責,對其準確性或完 整性亦不發表任何聲明,並明確表示概不就因本公佈全部或任何部分內容而產生或因依賴該等內容 而引致的任何損失承擔任何責任。 LifeTech Scientific Corporation 先健科技公司 (在開曼群島註冊成立的有限公司) – 2 – G-iliacTM Pro髂動脈覆膜支架系統 獲得中國國家藥品監督管理局的正式註冊批准 本公佈乃由先健科技公司(「本公司」,連同其附屬公司稱為「本集團」)自願作出,旨 在向其股東及潛在投資者提供有關本集團最新業務及新產品開發情況的資料。 本公司董事(「董事」)會(「董事會」)欣然宣佈,於二零二六年一月七日,本公司自主 研發的G-iliacTM Pro髂動脈覆膜支架系統(「G-iliacTM Pro」或「該產品」)獲中國國家 藥品監督管理局(「國家藥品監督管理局」)正式註冊批准。該產品適用於腹主動脈瘤 合併髂動脈瘤或孤立髂總動脈瘤的腔內治療,通過重建髂內動脈確保盆腔供血,為 臨床提供了更成熟、更完善的解決方案,實現了對既有治療方案的系統性升級。 髂內 ...