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樂普醫療(300003.SZ):完全可降解封堵器系統獲得NMPA註冊申請受理
格隆匯 02-03 20:31

格隆匯 2 月 3日丨樂普醫療(300003.SZ)公佈,公司於今日獲悉,公司全資子公司上海形狀記憶合金材料有限公司(“上海形狀”)研發完全可降解封堵器系統獲得國家藥品監督管理局下發的《受理通知書》是目前全球第一款可降解封堵器產品,也公司繼生物可吸收支架Neovas、藥物球囊Vesselin、切割球囊Vesscide上市後,在推進心血“介入無植入”創新時代進程的又一重磅產品

心臟封堵器作為介入治療的植入器械,適用於先天性心臟病缺損治療,目前市面上採用的封堵器均是金屬材料編織而成,植入後永久留存體內。新型可降解封堵器採用生物可降解材料製成,植入人體後可逐漸被人體自身組織包裹並逐步降解生成水和二氧化碳排出體外,為心臟的自身修復提供一座臨時“橋樑”,在治療缺損的同時,實現了“植入無殘留”,杜絕了遠期併發症,併為未來治療保留了通道,帶給患者終身獲益和生命品質的提升。

此次獲得註冊受理的完全可降解封堵器系統作為公司MemoSorb可降解封堵器系列產品之一,上海形狀歷經8創新研發與國家生物醫學材料工程研究中心、國家心臟中心共同開發的全新一代封堵器該產品擁有完全自主知識產權,適用於先天性心臟病室間隔缺損的治療,封堵器的骨架與縫合線均選用可降解絲材編織定型而成。材料為目前臨牀上廣泛應用與研究的可降解材料,從根本上保證了植入的安全性,避免了金屬封堵器永久性植入可能帶來的遠期併發症。

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