啟明醫療-B(02500.HK)TriGUARD3註冊申請獲國家藥監局受理
格隆匯10月11日丨啟明醫療-B(02500.HK)發佈公吿，國家藥品監督管理局已正式受理公司提交的TriGUARD3抗栓塞遠端腦保護(CEP)裝置的註冊申請。該產品用於經導管主動脈瓣置換術(TAVR)中，使栓塞碎片偏移出腦循環，以最大限度降低腦損傷風險。
TriGUARD3是目前全球唯一獲CE認證通過的TAVR手術中覆蓋整個升主動脈弓的CEP裝置，由集團子公司Keystone HeartLtd.開發，並於2020年3月獲得歐盟CE認證。2021年1月15日在海南博鰲樂城完成亞洲首例使用，2021年3月14日在香港完成亞太地區首例商業化應用。
TriGUARD3在美國開展的REFLECT II期註冊臨牀研究中達到主要安全終點，同時，基於DW-MRI的post-hoc分析表明，TriGUARD3有助於分流大尺寸危險斑塊，從而良好地預防缺血性腦損傷的發生，以保護腦組織。TAVR手術是目前主流用於治療嚴重主動脈瓣膜狹窄的微創介入治療手術，但TAVR術後神經事件（腦栓塞、缺血性腦卒中等）仍是常見的手術相關併發症之一，發生率約為2%-6%。TriGUARD3通過覆蓋主動脈分支無名動脈、左頸動脈和鎖骨下動脈三支開口，最大程度降低TAVR手術過程中出現腦損傷風險，有效預防圍術期卒中事件，對腦組織進行全面保護。
CEP裝置隨着介入手術（尤其是TAVR手術）的滲透和發展在全球應用比例穩步升高。根據弗若斯特沙利文預測，CEP設備在美國，歐盟和中國市場規模將於2018年至2025年按照35.15%,35.5%和79.5%增長。自TriGUARD3於歐洲獲批以來，市場份額持續上升，截至2021年6月30日，TriGUARD3的市場份額已達12%，銷售額同比顯著增長。董事會期待TriGUARD3在中國早日上市，造福更多患者。
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