先健科技(01302.HK)IBS冠脈支架獲批中國確證性臨床
先健科技(01302.HK)公布,於8月25日,集團自主研發的IBS可吸收藥物洗脫冠脈支架系統獲得在中國進行確證性臨床試驗的默示許可。該信息已發佈在國家藥品監督管理局醫療器械技術審評中心網站上,產品將在中國正式啟動臨床試驗。
IBS冠脈支架是全球首款全降解鐵基可吸收冠脈支架。在完成對血管的有效支撐後(即植入後3-6 個月)便開始降解,於2年左右安全進入降解尾聲,最終被人體組織所無害吸收。公司指,獲批中國確證性臨床,是在鐵基生物可吸收材料研發歷程中的重大里程碑。
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