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先健科技(01302.HK):獲FDA批准的一項研究者發起的LAmbreTM Plus左心耳封堵器系統的上市前臨牀於美國獲得醫保覆蓋
格隆匯 09-05 08:12

格隆匯9月5日丨先健科技(01302.HK)發佈公吿,集團於2022年3月2日獲得美國食品藥品監督管理局(FDA)批准的LAmbreTM Plus左心耳封堵器系統的一項臨牀試驗,已於2022年8月30日獲得美國醫保覆蓋。該試驗由研究者發起,且全部患者入組將會獲得全額醫保覆蓋。該試驗旨在評估相較於口服抗凝藥,LAmbreTM Plus左心耳封堵器對具有大尺寸及/或不規則形態心耳的非瓣膜性房顫患者進行手術封堵的安全性和有效性。

該試驗將於美國開展前瞻性、隨機、多中心研究,於不超過75家美國研究中心招募逾3000名受試者進行分組對照試驗,對照組口服抗凝藥。預計該試驗將有償植入該器械逾1500例,並將在達到既定的臨牀里程碑後向FDA遞交產品上市申請。

公司自主研發的LAmbreTM Plus左心耳封堵器系統是在LAmbreTM 左心耳封堵器系統的基礎上進一步結構優化的產品。LAmbreTM左心耳封堵器系統在產品設計及技術上均具行業先進性,其目前已在全球逾40個國家累計臨牀應用近兩萬例。這是本集團國際化發展歷程中的一項重大里程碑。公司有信心該器械在完成美國上市前臨牀研究後,順利獲得美國FDA的上市前批准。

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