沛嘉醫療-B(09996.HK):HighLife®經導管二尖瓣置換系統多中心註冊臨牀試驗於中國的首例患者入組
格隆匯11月14日丨沛嘉醫療-B(09996.HK)發佈公吿,公司已就沛嘉HighLife®經導管二尖瓣置換(經房間隔二尖瓣置換,“TSMVR”)系統的多中心註冊臨牀試驗入組首位患者,並在四川大學華西醫院已成功完成首例植入。沛嘉 HighLife® TSMVR系統註冊臨牀試驗是一項單組目標值、前瞻性、多中心研究,旨在評估該系統治療中度至重度或重度二尖瓣返流患者的安全性及有效性。該研究由四川大學華西醫院陳茂教授牽頭,涉及全國十二個一流中心。該多中心註冊臨牀試驗的結果將被納入公司未來向國家藥監局提交的註冊申請。
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