先健科技(01302.HK):Epione®穿刺手術導航定位系統獲國家藥監局正式註冊批准
格隆匯8月21日丨先健科技(01302.HK)發佈公吿,2023年8月16日,集團合資控股公司東莞先健量子醫療科技有限公司引進的Epione®穿刺手術導航定位系統“Epione®”獲中國國家藥品監督管理局正式註冊批准。
該產品在CT影像引導下,可協助術者對硬直器械的穿刺路徑進行規劃,並根據規劃提供穩定、精準、可重複的進針路徑和位置引導,解決“盲穿”面臨的高難度、高風險等一系列問題。Epione®能夠提高手術效率,減少穿刺針調整次數,降低患者輻射劑量,減少併發症的發生機率,尤其對於手術規劃和完成難度較高的病灶的治療具有極大的價值。2021年9月,Epione®獲得歐洲CE認證;2022年3月,獲美國食品和藥物管理局(“FDA”)批准可用於肝癌的治療;2023年5月, FDA批准Epione®應用範圍擴展至所有腹部腫瘤;2023年8月,Epione®獲得了國家藥品監督管理局的註冊批准,適應症覆蓋所有腹部器官。
Epione®是一種開放式機器人解決方案,可兼容消融、活檢、粒子植入等多種治療方式。對於腫瘤消融手術,Epione®的設計允許醫生選擇不同的消融技術(射頻、微波、冷凍消融、不可逆電穿孔),以便他們可以為每個患者決定適合的治療方法。Epione®的目標是簡化多針手術,這將會使得大腫瘤的治療更可預測。另外, Epione®的機械臂具有6個自由度和前所未有的靈巧性,可以治療複雜路徑的腹部腫瘤。 Epione®已逐步在歐美開展臨牀應用,預期全球將有超過400萬患者可以從Epione®治療中受益。集團亦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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