先健科技(01302.HK)Xuper™主动脉术中覆膜支架系统获得欧盟CE认证
2021年5月26日，领先的心脑血管及外周血管微创介入医疗器械企业——先健科技公司(01302.HK)宣布，其自主研发的Xuper™主动脉术中覆膜支架系统获得欧盟CE认证。该创新产品用于Stanford A型主动脉夹层的杂交手术治疗，是全球首个商业化的多分支术中覆膜支架系统，将为广大患者带来全新的临床治疗方案。
主动脉夹层是一种严重威胁患者生命健康的心血管疾病。其中Stanford A型主动脉夹层约占全部主动脉夹层的60%-70%[1]，其具有发病率高、病死率高等特点，未经手术治疗的急性Stanford A型主动脉夹层发病一周病死率超过70%[1]。目前临床上主要通过传统外科手术和杂交手术进行治疗。杂交手术相较于传统外科手术具有手术周期更短，对患者创伤相对较小等优势,成为当前治疗Stanford A型主动脉夹层的主流术式。但该术式在临床应用中依然存在着学习曲线长，术中吻合口多，深低温停循环时间长，术后并发症较多等问题。因此，开发一款能够优化现有杂交手术的术中覆膜支架系统具有重大意义。
基于对临床需求的深入洞察，先健科技Xuper™主动脉术中覆膜支架系统应运而生。Xuper™主动脉术中覆膜支架为独特的主体带分支“一体化”结构，拥有单分支、双分支及三分支三种型号系列。主体支架上各分支支架的角度和间距可根据患者的主动脉弓上分支血管解剖形态自适应调节，从而能够灵活满足不同的患者治疗需求。同时，与目前已上市的同类产品相比，其创新设计使手术无需进行创伤极大的主动脉全弓切除及置换，仅需切除部分主动脉弓部病变位置，并通过植入Xuper™主动脉术中覆膜支架对保留的弓上分支进行重建。此外，该术中覆膜支架主体近端为三层结构设计，便于术中止血钳夹持并与患者的升主动脉远端吻合，且无需对主体支架远端进行手术缝合，极大的减少了术中吻合口的数量，从而显著的缩短了手术时间。
这种新型的主动脉术中覆膜支架系统结合开放手术的方式，能够在保证手术质量的同时加快手术速度，缩短患者体外循环和深低温停循环的时间，有效降低术中死亡率和减少术后并发症的发生，同时降低了手术难度，使学习曲线更短，有利于其在全球范围内的推广和普及，从而挽救更多患者的宝贵生命。
Xuper™主动脉术中覆膜支架系统是先健科技在其主动脉全域治疗平台性布局上的重要创新产品之一。此次获得欧盟CE认证，为广大Stanford A型主动脉夹层患者提供了一种全新的、安全有效的手术治疗方案，并为进一步探讨拓宽其适应症奠定基础，将进一步夯实先健科技在主动脉疾病治疗领域的综合实力。
数据来源：
[1] 主动脉夹层诊断与治疗规范中国专家共识 [J].中华胸心血管外科杂志,2017(11)，33(11)：641-654
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