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<section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.jpg" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section data-tools="gulangu" data-id="97917"><section><section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><br /></p><p><span>近日，两大医械巨头美敦力、波士顿科学旗下的可插入式心脏监测仪双双获得FDA审批，宣布上市。</span></p><p><br /></p><p><span>心房颤动是脑卒中的一项重要危险因素，因其可预防性故房颤的早期检测及治疗对脑卒中意义重大。植入式心脏检测仪埋藏在患者皮下，长期监测患者在各种情形下的心电图。监测的时间长，医生可通过遥测技术对其记录的心电图进行复制和分析，提高心律失常的诊断率。</span></p><p><br /></p><section data-support="96编辑器" data-style-id="22631"><section><section><p><span><strong>01</strong></span></p></section><section><section><strong>波士顿科学LUX-Dx</strong></section></section></section></section><p><br /></p><p><span>近日，波士顿科学的可插入式心脏监测仪LUX-Dx也获得了FDA认证。该植入物用于检测难以发现的心律不齐，如房颤，病帮助诊断来源。</span></p><p><br /></p><p><video width="100%" height="580" controls="controls"><source src="http://mpvideo.qpic.cn/0b784qaagaaadaaawtqmjjpvbzgdapsaaaya.f10002.mp4?dis_k=371a3bde9456d367402bb5f091ecdfeb&dis_t=1602647234" type="video/mp4"></source></video></p><p><br /></p><p><span>该设备的检测算法由两个独立部分组成，其一检测可疑的心率失常，其二则对其验证。一旦确认了心律不齐，设备就会通过手机上的应用程序将信号发给医生。</span></p><p><br /></p><p><p><img src="image/20201014/b3723b02dde7f04a49a31abbdd863160_2.jpg" /></p></p><section><br /></section><section><span>LUX-Dx可插入式心脏监测仪可以在医生的定义操作下，识别心房颤动（AFib）、心律暂停、心房扑动、心动过缓和心动过速等。</span></section><section><br /></section><section data-support="96编辑器" data-style-id="22631"><section><section><p><span><strong>02</strong></span></p></section><section><section><strong>美敦力 Linq II</strong></section></section></section></section><section><br /><span></span></section><p><span>美敦力（Medtronic）日前表示，其Linq II可插入式心脏监护仪已获得FDA 510（k）许可和CE认证，可以由患者的医生进行远程编程。公司计划在今年夏天晚些时候在美国和欧洲市场推出该设备。</span></p><p><br /></p><p><p><img src="image/20201014/e9276fe2b0b01fed12999eba4d513817_3.jpg" /></p></p><p><br /></p><p><span>该设备分为两个主要部分，一是可通过微创手术放置于皮下的小型可插入心脏监视器（ICM）；二是收集并发送ICM传输数据的安装于智能手机/平板电脑的程序。Linq II拥有世界上最精准的ICM系统，可连续工作4.5年（前代产品可工作3年），拥有远程接发心率数据的功能，Linq II可兼容MRI检查。</span></p><p><br /></p><p><span>在COVID-19时代，医疗设备的远程监控和编程功能通过减少与医生进行尽可能多的面对面互动的需求而获得了新的关注。美敦力（Medtronic）首席执行官杰夫·玛莎（Geoff Martha）称此类功能对于设备至关重要，并声称该公司已做好充分准备，可以利用医院对功能的不断增长的需求，特别是当提供商致力于减少其员工对该病毒的暴露时。</span></p><p><br /></p><p><span>除远程编程外，Linq II设备还允许患者在两种监测途径之间进行选择。患者可以使用智能手机通过支持蓝牙安全通信的移动应用程序自动传输设备数据，也可以通过家庭通讯器传输设备数据。</span></p><p><br /></p><p><span>通过连续监测生成的患者数据可以帮助医生诊断和管理慢性心律不齐，例如房颤。Medtronic表示，Linq II系统还可以检测到室性早搏，这是一种额外的异常心跳，始于心室并打乱了心律。</span></p><p><br /></p></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="paragraph"><section><section><section data-brushtype="text"><strong>相关阅读</strong></section></section></section><section><section><br /></section></section><section data-width="100%"><section><section><section><section data-width="100%"><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><section><p><img src="image/20201014/2aac877ff9233ba5a66e7a5ff3a4febf_4.gif" /></p></section><section 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发表于 2020-10-14 11:47:15