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宜安科技(300328.SZ):可降解鎂骨內固定螺釘取得臨牀試驗總結報吿
格隆匯 01-07 18:29

格隆匯1月7日丨宜安科技(300328.SZ)公佈,公司可降解鎂骨內固定螺釘成功取得臨牀試驗總結報吿。公司研發的可降解鎂骨內固定螺釘,以99.99wt.%高純鎂製成,元素單一,無多元素毒性影響,具有生物安全性優勢。用於保髖治療微創手術,可促進患處骨骼生長及修復。可降解鎂骨內固定螺釘具有良好的生物相容性以及與骨組織接近的力學性能,能促進成骨,在實現體內修復功能的同時逐漸降解,不在體內殘留,避免二次手術取出給患者及其家屬造成心理、生理及經濟上負擔,是一類極具臨牀應用前景的骨科植入器械。

臨牀試驗總結報吿表明可降解鎂骨內固定螺釘在股骨頭缺血性壞死帶血管蒂骨瓣移植治療中有效且安全,公司後續將向國家藥品監督管理局遞交該產品的註冊申請。

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