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佰仁醫療(688198.SH):介入式瓣中瓣系統臨牀試驗完成備案
格隆匯 05-24 17:19

格隆匯5月24日丨佰仁醫療(688198.SH)公佈,近日,公司在研產品RenatoTM介入式瓣中瓣系統於臨牀試驗牽頭單位復旦大學附屬中山醫院通過倫理會審查,並完成在北京市食品藥品監督管理局備案,

公司介入式瓣中瓣系統專用於此前植入或介入的各類人工生物瓣膜術後若干年因各種原因發生了毀損或衰敗而需要再介入治療的患者。其治療的原理就是在毀損或衰敗失功的生物瓣膜裏經導管介入一個新瓣膜。

與之前國內上市的介入瓣不同之處在於:①該產品是球擴式牛心包介入瓣;②按外科生物瓣開啟關閉的模式設計;③型號規格匹配外科生物瓣;④該系統配有長、短兩套輸送裝置,以滿足不同瓣位路入的需要。

本次臨牀試驗具有以下特點:①不限瓣位(可以二尖瓣位,也可以是主動脈瓣位或三尖瓣位);②不限毀損或衰敗失功的生物瓣膜的種類(可以是外科植入的牛心包瓣或豬主動脈瓣,也可以是介入瓣);③不限路入途徑(根據患者的具體病情確定路入方式)。

該產品是為了滿足國內瓣膜病手術患者普遍年齡偏輕(多為65歲以下)、風心病導致的二尖瓣位換瓣居多以及未來植介入生物瓣比例逐年增加而帶來的再介入治療需求。

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