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先健科技(01302.HK)新一代左心耳封堵器LAxible™獲中國註冊批准
格隆匯 09-09 08:30

2021年9月8日,先健科技公司(01302.HK)宣佈,其自主研發的新一代左心耳封堵器LAxible(以下簡稱“LAxible”)已獲得國家藥品監督管理局(NMPA)註冊批准,標誌着先健科技在左心耳封堵領域正式邁入全面升級,快速發展的新時代。

近年來,隨着海內外循證醫學的不斷髮展和進步,經皮左心耳封堵術已成為非瓣膜性房顫患者預防左心耳內血栓脱落導致腦卒中的重要方法。

基於首代產品LAmbre左心耳封堵器在全球40餘個國家和地區累計一萬例植入數據的良好反饋,並從日益發展的臨牀治療需求出發,先健科技新一代左心耳封堵器LAxible——應運而生。該裝置在首代產品獨特優勢的基礎上進行了設計優化和技術升級,通過對封堵器固定盤及阻流膜進行的一系列創新設計,進一步提升了產品的安全性和有效性,為醫生帶來更便利的手術操作,為患者帶來更佳的治療效果。

作為國內唯一不斷迭代左心耳封堵器並實現其商業化的中國創新企業,先健科技堅持對產品不斷創新優化,促進臨牀治療方案的多層級、差異化發展,以在全球範圍為更多房顫患者帶來更規範、更先進的預防卒中解決方案。

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