佰仁醫療(688198.SH):經導管瓣中瓣系統註冊申請獲得受理
格隆匯10月20日丨佰仁醫療(688198.SH)公佈,公司在研產品經導管瓣中瓣系統提交註冊申請並獲國家藥品監督管理局醫療器械技術審評中心正式受理。該系統是專門為已接受過植介入各類人工生物心臟瓣膜的術後患者,由於各種原因體內的生物瓣發生了毀損或失功,需要二次換瓣而面臨手術高風險時可通過介入的方式將一枚新瓣膜放置於毀損或失功的瓣膜內,以替代發生毀損或失功的各類生物瓣。臨牀試驗結果表明,國內正在應用的十一種發生毀損或失功的各類植介入人工生物瓣均被經導管瓣中瓣系統成功替代,使這些患者被成功救治,免於二次手術風險。
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