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先健科技(01302.HK):LAxibleTM 左心耳封堵器獲國家藥監局正式註冊批准
格隆匯 09-08 17:22

格隆匯9月8日丨先健科技(01302.HK)發佈公吿,2021年9月2日,集團自主研發的LAxibleTM左心耳封堵器(LAxibleTM)獲中國國家藥品監督管理局正式註冊批准。

該器械在LAmbreTM左心耳封堵器"LAmbreTM的基礎上對固定盤及阻流膜進行了一系列創新設計,基於LAmbreTM的良好臨牀反饋,進一步提升該器械的安全性及有效性。同時,該器械可以更好地滿足市場日益增多的房顫消融與左心耳封堵相結合的一站式手術方案,減少房顫患者痛苦,提高患者的臨牀體驗感。

集團旨在多代佈局左心耳封堵器,通過LAmbreTM與LAxibleTM產品持續滿足多樣化臨牀需求。集團將繼續堅持自主創新,攜手業內專家推進創新醫療器械產品的研發和上市進程,造福廣大患者。

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