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先健科技(01302.HK):Yuranos™腹主動脈覆膜支架系統獲得中國國藥監局的註冊批准
格隆匯 11-24 18:23

格隆匯11月24日丨先健科技(01302.HK)宣佈,於2021年11月23日,集團自主研發的Yuranos腹主動脈覆膜支架系統"Yuranos"或"該器械")獲中國國家藥品監督管理局的註冊批准。

Yuranos用於腎下型腹主動脈瘤的治療。相較同類型產品,適用於臨牀中更復雜的瘤體形態,可滿足更極限的臨牀解剖結構,具備更廣泛的適應症:腹主動脈瘤近端最小瘤頸長度10mm,最大腎下成角75°。該器械為分體式設計,包含腹主動脈分叉支架系統和髂動脈延長支架系統。各系統均包含支架和輸送器,支架由鎳鈦骨架和PET覆膜組成,每個支架裝載在各自的輸送器中,手術時分別由輸送器輸送和釋放到預定位置。該器械同時具備獨特設計,有效提升術中和遠期治療效果,降低手術併發症風險:i)腹主動脈分叉支架主體覆膜近端裸段倒刺和閉環mini支撐波設計,增加支架錨定性、貼壁性和柔順性,有效防止移位和I型內漏;ii)髂動脈延長支架倒刺設計,增強組件間連接力,有效防止組件脱落導致的III型內漏;iii)輸送器後釋放功能配合支架組件錨定設計,實現精準定位和調控,進一步提升器械可用性和即刻手術成功率。

集團將繼續堅持自主創新,攜手業內專家推進創新醫療器械產品的研發和上市進程,造福廣大患者。

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