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佰仁醫療(688198.SH):心臟瓣膜生物補片獲批註冊
格隆匯 07-26 16:04

格隆匯7月26日丨佰仁醫療(688198.SH)公佈,近日,經國家藥品監督管理局審查,北京佰仁醫療科技股份有限公司心臟瓣膜生物補片獲准註冊,是國內同品種首個專用於各瓣位心臟瓣膜瓣葉修復、主動脈瓣葉成形和重建的產品,填補了國內空白。

心臟瓣膜生物補片產品源自本公司現有外科生物瓣的瓣葉片材,即外科牛心包瓣的瓣葉部件,其化學改性處理及抗鈣化和耐疲勞性能特徵完全相同,由於佰仁外科生物瓣產品已歷經二十餘年的生產實踐和多家中心大組長期臨牀隨訪數據驗證,使這款心臟瓣膜生物補片為近年來越來越多開展的心臟瓣膜成形和重建提供優質耐久的瓣葉材料。

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