愛康醫療(01789.HK)獲得藥監局批准的金屬增材製造胸腰椎融合匹配式假體系統三類醫療器械註冊證
格隆匯4月24日丨愛康醫療(01789.HK)公吿,集團於2023年4月21日通過創新通道獲得中華人民共和國("中國")國家藥品監督管理局("藥監局")批准的金屬增材製造胸腰椎融合匹配式假體系統三類醫療器械註冊證。
胸腰椎椎體腫瘤、嚴重粉碎性骨折以及某些感染性疾病如結核等,常引起椎體的缺損,這些因素所導致的骨缺損很難通過機體自身的癒合能力進行修復,尤其是長節段骨缺損,很容易引起椎體畸形、功能障礙等嚴重併發症,不僅降低了患者生存質量,甚至有癱瘓乃至死亡的危險。
金屬增材製造胸腰椎融合匹配式假體系統由胸腰椎融合匹配式假體,組件釘釦及椎弓根螺釘組成。經過與臨牀醫生7年的研究探索,建立了椎體切除重建R-Truss結構理論,通過脊柱穩定性重建的"桁架"結構設計,胸腰椎融合匹配式假體可實現與後路釘棒系統橫向穩定連接,從而形成整體穩定的"桁架"結構,假體系統穩定性和融合率得到顯著提高。
近年來,集團在3D打印定製化ICOS服務和產品上持續創新,從2020年獲證的金屬3D打印骨盆缺損匹配假體和金屬3D打印定製化頸椎融合體,到2023年獲得的以金屬增材製造匹配式長段骨缺損修復體和胸腰椎融合匹配式假體為代表的個性化定製產品的推出,ICOS骨科定製平台不斷完善成熟,集團的3D打印解決方案進一步豐富。
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