康拓醫療(688314.SH):3D打印PEEK顱骨系統進入創新醫療器械特別審查程序
格隆匯4月18日丨康拓醫療(688314.SH)公佈,公司自主研發的增材製造聚醚醚酮顱骨缺損修復假體(即3D打印PEEK顱骨系統)產品於近日獲國家藥品監督管理局醫療器械技術審評中心同意進入創新醫療器械特別審查程序,該產品將按照創新醫療器械進行註冊審評審批。
3D打印PEEK顱骨系統是採用選區激光燒結(SLS)的3D打印技術對PEEK粉料進行個性化加工製成顱骨修補板,適用於顱骨缺損修補重建的外科治療,該產品不僅具有更精準的加工精度及更優的表面質量,而且克服了PEEK粉料SLS打印中未燒結區域原材料重複使用的關鍵難題,相比傳統機械加工方法,極大地節省了原材料,降低了產品成本,惠及於患者。
創新醫療器械特別審查程序是針對具有國內發明專利、技術上具有國內首創、國際領先水平,並且具有顯著臨牀應用價值的醫療器械設置的特別審批通道。公司“3D打印PEEK顱骨系統”產品此次進入創新醫療器械特別審查程序後,國家藥品監督管理部門及相關技術機構將按照早期介入、專人負責、科學審查的原則,在標準不降低、程序不減少的前提下進行優先審評審批,因此,此次“3D打印PEEK顱骨系統”產品進入創新醫療器械特別審查程序,不僅標誌着該產品具有領先的技術優勢及顯著的臨牀應用價值,同時將有助於縮短該產品的註冊週期,加快其上市進程,進一步豐富公司的產品類別,增強公司在神經外科領域的核心競爭力。
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