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心通醫療-B(02160.HK):AnchorMan®左心耳封堵器系統獲得中國國家藥品監督管理局頒發的註冊批准
格隆匯 01-07 19:49

格隆匯1月7日丨心通醫療-B(02160.HK)公佈,於2024年1月5日,上海佐心自主研發的左心耳封堵器產品AnchorMan®左心耳封堵器系統獲得中國國家藥品監督管理局頒發的註冊批准,成為目前中國唯一獲批的半封閉型左心耳封堵器產品。此外,其已於2023年12月遞交了CE標誌註冊申請。

AnchorMan®左心耳封堵器系統由左心耳封堵器和輸送系統組成,適用於 CHA2DS2-VASC(一種卒中風險評估工具)得分≥2,且有長期口服抗凝治療禁忌或抗凝治療後仍有卒中風險的非瓣膜性房顫患者。

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