先健科技(01302.HK)左心耳封堵器系統臨牀試驗獲美國醫保覆蓋
先健科技(01302.HK)公佈,集團於今年3月2日獲得美國食品藥品監局(FDA)批準的LAmbre Plus左心耳封堵器系統的一項臨牀試驗,已於8月30日獲得美國醫保覆蓋。
該試驗由研究者發起,且全部患者入組將獲得全額醫保覆蓋。該試驗旨在評估相較於口服抗凝藥,LAmbre 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,於不逾75家美國研究中心招募逾3,000名受試者進行分組對照試驗,對照組口服抗凝藥。預計該試驗將有償值入該器械逾1,500宗,並將在達到既定的臨牀裏程碑後向FDA遞交產品上市申請。
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