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先健科技(01302):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
智通财经网· 2026-01-08 11:23
Core Viewpoint - The approval of the G-iliacTM Pro iliac artery stent system marks a significant advancement in the company's product offerings, enhancing its position in the minimally invasive treatment of aortic diseases and providing improved solutions for iliac artery reconstruction [1][3]. Group 1: Product Approval and Features - The G-iliacTM Pro stent system received formal registration approval from the National Medical Products Administration of China on January 7, 2026, and is designed for endovascular treatment of abdominal aortic aneurysms combined with iliac artery aneurysms or isolated common iliac artery aneurysms [1]. - The G-iliacTM Pro consists of the G-iliacTM Pro stent and SilverFlowTM Pro stent, maintaining a two-piece combination for safety and convenience, with a low-profile delivery system and ergonomic design for improved operation [2]. Group 2: Clinical Significance and Market Impact - The G-iliacTM system, 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]. - The company aims to provide a comprehensive solution for aortic minimally invasive treatments, pushing for a more systematic, standardized, and efficient development phase in treating complex aortic diseases [3].
先健科技(01302) - 自愿性公佈 - G-Branch TM 胸腹主动脉覆膜支架系统获得中国国...
2025-11-06 12:45
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) (股份代號:1302) 自願性公佈 G-BranchTM胸腹主動脈覆膜支架系統 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 本公司董事(「董事」)會(「董事會」)欣然宣佈,於二零二五年十一月六日,由中國人 民解放軍總醫院第一醫學中心郭偉教授團隊與本集團聯合研發的 G-BranchTM胸腹主 動脈覆膜支架系統(「G-BranchTM」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。該產品適用於胸腹主動脈瘤(「TAAA」)累及腹腔 病變類型之一,瘤體一旦破裂,患者死亡率高達 95%。傳統開放手術風險極高, 創傷巨大,胸腹聯合切口可長達 1 米,手術耗時需 12 個小時,手術全身縫合超過 1, ...