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先健科技(01302.HK):LAmbre Plus 左心耳封堵系統的上市前臨牀試驗於美國獲得醫保覆蓋
格隆匯 03-21 18:48

格隆匯3月21日丨先健科技(01302.HK)公告,集團的LAmbre Plus左心耳封堵系統的一項臨牀試驗,已於2025年3月19日獲得美國醫保覆蓋。該試驗由公司發起,且全部患者入組將會獲得醫保覆蓋。該試驗旨在通過與市售經導管LAAO對照器械進行隨機對比,證明LAmbre Plus在降低非瓣膜性房顫患者血栓栓塞風險方面的安全性和有效性。

該試驗爲一項前瞻性、多中心、隨機對照研究,並計劃於不超過75家美國研究中心有償植入LAmbre Plus。在達到既定的臨牀里程碑後,公司將向美國食品藥品監督管理局(FDA)遞交產品上市申請。

公司自主研發的LAmbre Plus是在LAmbre左心耳封堵系統的基礎上進一步結構優化的產品。LAmbre在產品設計及技術上均具行業先進性,其目前已在全球近四十個國家累計臨牀應用近四萬例。這是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的上市批準。

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