樂普醫療(300003.SZ):左心耳封堵器系統獲NMPA註冊批准
格隆匯6月12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自主研發的左心耳封堵器系統(MemoLefort)已獲得國家藥品監督管理局的註冊批准,取得《醫療器械註冊證》(國械注準20203130560)。
MemoLefort左心耳封堵器採用內塞式設計,由形狀記憶合金鎳鈦骨架作為支撐,具備良好的徑向支撐力和順應性,適用於大部分左心耳結構。微米級的阻流膜能夠加速內皮化進程、阻斷進入左心耳的血流,封堵器邊緣的一體式倒刺確保釋放後器械穩固於左心耳內部。
MemoLefort左心耳封堵器系統的臨牀試驗共納入178例研究對象,覆蓋13家臨牀中心。臨牀試驗結果顯示:術後12個月左心耳關閉率為97.6%,12個月內的缺血性腦卒中率為0%,這一結果表明:對於不適合長期使用抗凝藥物治療的非瓣膜性房顫患者,植入MemoLefort左心耳封堵器可有效降低卒中風險,安全性高,可廣泛應用於臨牀。
中國有約1000萬房顫患者,隨着目前社會老齡化的趨勢,患病率也將隨之增加。房顫患者罹患腦卒中的風險是正常人羣的5倍,所以卒中的風險控制和房顫病人的血栓管理的必要性已經成為各界共識。在非瓣膜性房顫患者人羣中,超過90%的血栓來源於左心耳,實施左心耳封堵術可以在一定程度上降低房顫患者中風發生的概率。MemoLefort左心耳封堵器植入後內嵌於左心耳內部,安全穩固且不影響心耳周圍組織,從源頭上堵住了血栓形成的部位,達到不需長期服用抗凝藥就能預防血栓和卒中的目的,大大提高了患者的生活質量。
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