天智航(688277.SH):骨科手術導航定位系統通過創新醫療器械特別審查程序
格隆匯11月18日丨天智航(688277.SH)公佈,公司“骨科手術導航定位系統”進入創新醫療器械特別審查申請的審查結果公示期已結束(在國家藥品監督管理局醫療器械技術審評中心網站可查詢),本產品將按創新醫療器械進行註冊審評審批。
骨科手術導航定位系統TiRobot Recon是一款全膝關節置換手術機器人。該產品輔助外科醫生進行全膝關節置換手術,系統輔助醫生完成基於患者解剖和運動學的個體化關節置換手術設計,並完成定位膝關節假體安裝需要的截骨定位。目前國內尚無同類產品上市。
該手術機器人以創新的全膝關節置換手術理念為手術規劃的設計基礎,將伸屈間隙平衡、下肢力線重建和膝關節力負荷信息進行匯聚分析,構建一種全膝關節置換術中決策模型和術後療效評估系統,幫助術中更好地實現自然下肢力線的重建和軟組織平衡的兼顧,以實現最佳的臨牀結局和患者滿意度。該產品採用機器人引導截骨方案,無須開髓、打骨針、更換工具即可完成定位截骨,大大提高了截骨精度,減少了手術創傷,提高了手術效率。
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