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先健科技(01302.HK):IBS Angel™鐵基可吸收支架系統馬來西亞註冊獲批
格隆匯 06-09 16:58

格隆匯6月9日丨先健科技(01302.HK)宣佈,於2021年6月8日,集團自主研發的IBS Angel鐵基可吸收支架系統(IBS Angel)已於馬來西亞獲得註冊批准。

IBS Angel™由鐵基可吸收支架和支架輸送系統組成,用於改善需要支架治療的患者的肺血管管腔直徑。支架基體是由高強度的滲氮鐵管加工而成,支架杆壁上有多個斷點設計,使支架在完成有效支撐後能夠儘快解構,不再束縛血管。完成治療後,支架可降解,最終被人體自身組織所吸收,創新的材料和結構設計可以確保支架具有合理的吸收週期。

相較於目前市場上的永久支架,該產品在治療新生兒和低齡兒童肺血管供血不足上具有獨特優勢。因為隨着患兒成長,永久支架會束縛血管長大,造成血管再狹窄而需要二次介入,甚至需要外科手術才能解決上述問題,對患兒身體產生額外負擔。而產品由於其具有可降解性,將從根本上解決此類問題。此外,IBS Angel™採用薄壁設計,最小可兼容4F鞘管(內徑約為1.35毫米),特別適合新生兒的細小血管。

目前IBS Angel™已在馬來西亞獲批銷售,成為全球唯一適用於兒童的可吸收支架產品,造福患者。同時,產品正在積極進行CE和國內註冊工作,有望成為歐盟和國內首款上市的鐵基可吸收支架。

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