樂普醫療(300003.SZ):MemoSorb®全降解封堵器系統獲准上市
格隆匯2月16日丨樂普醫療(300003.SZ)公佈,公司旗下結構性心臟病醫療器械平台樂普心泰醫療科技(上海)股份有限公司(以下簡稱:心泰醫療)全資子公司上海形狀記憶合金材料有限公司自主研發的MemoSorb®全降解封堵器系統於近日正式獲得國家藥品監督管理局批准的醫療器械註冊證。
先天性心臟病是指在胚胎髮育時期由於心臟及血管的形成障礙或發育異常或出生後應自動關閉的通道未能閉合,導致心臟或胸腔內血管的立體結構或功能上的異常。先天性心臟病的臨牀金標準為介入封堵術,通過外周血管穿刺及輸送導管將封堵器推送至先天性心臟發育缺損的相應部位。
根據第三方諮詢公司弗若斯特沙利文數據,中國2020年的先心病患者人數為13.45萬人,預計2030年將達到14.55萬人;全球2020年先天性心臟病患者人數為170萬人,預計至2030年將保持穩定。
心泰醫療自主研發的全降解封堵器系統實現了封堵器從金屬材質到全降解材質的創新升級,封堵器植入人體後將起到臨時橋樑作用,促進完成自體組織修復後逐步降解,最終成為二氧化碳和水排出體外,無異物留存,避免了傳統金屬封堵器植入後永久留存於體內帶來的遠期併發症風險,為患者重塑健康的心臟。公司踐行“介入無植入”的臨牀理念,全降解封堵器系統將為先心病患者提供更豐富的選擇。
全降解封堵器系統的研發成功及獲准上市有利於進一步拓寬公司結構性心髒病產品線,增強公司在心血管介入領域的核心競爭力,對公司經營發展產生積極影響。
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