先健科技(01302.HK)Xuper™主動脈術中覆膜支架系統獲得歐盟CE認證
2021年5月26日，領先的心腦血管及外周血管微創介入醫療器械企業——先健科技公司(01302.HK)宣佈，其自主研發的Xuper™主動脈術中覆膜支架系統獲得歐盟CE認證。該創新產品用於Stanford A型主動脈夾層的雜交手術治療，是全球首個商業化的多分支術中覆膜支架系統，將為廣大患者帶來全新的臨牀治療方案。
主動脈夾層是一種嚴重威脅患者生命健康的心血管疾病。其中Stanford A型主動脈夾層約佔全部主動脈夾層的60%-70%[1]，其具有發病率高、病死率高等特點，未經手術治療的急性Stanford A型主動脈夾層發病一週病死率超過70%[1]。目前臨牀上主要通過傳統外科手術和雜交手術進行治療。雜交手術相較於傳統外科手術具有手術週期更短，對患者創傷相對較小等優勢,成為當前治療Stanford A型主動脈夾層的主流術式。但該術式在臨牀應用中依然存在着學習曲線長，術中吻合口多，深低温停循環時間長，術後併發症較多等問題。因此，開發一款能夠優化現有雜交手術的術中覆膜支架系統具有重大意義。
基於對臨牀需求的深入洞察，先健科技Xuper™主動脈術中覆膜支架系統應運而生。Xuper™主動脈術中覆膜支架為獨特的主體帶分支“一體化”結構，擁有單分支、雙分支及三分支三種型號系列。主體支架上各分支支架的角度和間距可根據患者的主動脈弓上分支血管解剖形態自適應調節，從而能夠靈活滿足不同的患者治療需求。同時，與目前已上市的同類產品相比，其創新設計使手術無需進行創傷極大的主動脈全弓切除及置換，僅需切除部分主動脈弓部病變位置，並通過植入Xuper™主動脈術中覆膜支架對保留的弓上分支進行重建。此外，該術中覆膜支架主體近端為三層結構設計，便於術中止血鉗夾持並與患者的升主動脈遠端吻合，且無需對主體支架遠端進行手術縫合，極大的減少了術中吻合口的數量，從而顯著的縮短了手術時間。
這種新型的主動脈術中覆膜支架系統結合開放手術的方式，能夠在保證手術質量的同時加快手術速度，縮短患者體外循環和深低温停循環的時間，有效降低術中死亡率和減少術後併發症的發生，同時降低了手術難度，使學習曲線更短，有利於其在全球範圍內的推廣和普及，從而挽救更多患者的寶貴生命。
Xuper™主動脈術中覆膜支架系統是先健科技在其主動脈全域治療平台性佈局上的重要創新產品之一。此次獲得歐盟CE認證，為廣大Stanford A型主動脈夾層患者提供了一種全新的、安全有效的手術治療方案，併為進一步探討拓寬其適應症奠定基礎，將進一步夯實先健科技在主動脈疾病治療領域的綜合實力。
數據來源：
[1] 主動脈夾層診斷與治療規範中國專家共識 [J].中華胸心血管外科雜誌,2017(11)，33(11)：641-654
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