世界最小起搏器，正式进入中国市场！

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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.png" /></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><p><br  /></p><p><span>近日，有一则值得国内心血管病领域从业人员和患者振奋的消息得到了证实，曾做过专题报道的“世界最小起搏器”</span><span>（婴儿用除外）</span><span>在经过了漫长的中国本土临床研究后，终于获得NMPA批准，正式于中国上市！</span></p><p><span><br  /></span></p><p><iframe src="https://v.qq.com/iframe/player.html?width=500&height=375&auto=0&vid=y03151f9prx&auto=0" width="100%" height="580" frameborder="0"></iframe></p><p><span>一睹为快 &nbsp;MICRA导管起搏系统</span></p><p><br  /></p><p><span>这款“世界最小起搏器”在NMPA的正式注册名称为：Micra Transcatheter Leadless Pacemaker System，注册型号为MC1VR01，是心脏支架巨头美敦力公司出品的一款<strong>经导管植入无导线心脏起搏系统</strong>，由植入式脉冲发生器（含固定翼）和输送导管组成。</span></p><p><br  /></p><p><p><img src="image/20201014/f13caa8f81506bb6ff6af3d0110dd905_2.png" /></p></p><p><br  /></p><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="87844" data-color="#27939d"><section data-width="20em"><section><section><p data-brushtype="text"><strong>经导管植入无导线心脏起搏系统</strong></p></section></section><section></section></section></section><section data-role="paragraph" data-color="#27939d"><p><br  /></p></section></section><p><span>人类对电流能够刺激心脏的认知已经由来已久，自1932年美国纽约贝斯-大卫医院胸科医生Hyman设计并制作净重高达7.2公斤的电脉冲发生器起，心脏起搏器就开始了近90年（四舍五入就是100年呐！）的发展进化史，在小型化、长效化，多腔起搏等领域越走越远，越走越成熟。</span></p><p><span><strong><br  /></strong></span></p><p><span>经导管植入无导线心脏起搏系统算是近年心脏起搏器最具颠覆性的创新技术之一，借用媒体的评价：“这是一次心脏起搏器的革命性进化！”普通植入式心脏起搏器由植在胸部皮下的脉冲发生器和通过静脉送入右心室的电极导线组成，在需要时向心脏发出微小的电脉冲，刺激心脏跳动。</span></p><p><br  /></p><p><p><img src="image/20201014/65331a9b10a676ecce4a6b07b3c40295_3.jpg" /></p></p><p><strong><br  /></strong><span>但研究人员在长期的临床应用中发现，心脏起搏器这种脉冲发生器+电极导线结构，容易导致<span>包括血气胸、三尖瓣反流、电极导线脱位、穿孔、电极导线断裂、栓塞以及起搏器囊袋破溃、感染等</span>一系列并发症，调查显示其综合发生概率约为 1/8。所以无导线心脏起搏技术的开发自然而然的被业内广泛关注。</span></p><p><span></span></p><p><br  /></p><p><span>无导线起搏器，顾名思义，它将脉冲发生器与起搏电极融为一体，以微缩胶囊形式植入患者心脏，放弃在静脉植入心内膜导线，且无需皮下切口和囊袋，彻底颠覆了传统起搏器的植入方式，在解决了并发症风险的同时，兼具传统心室单腔起搏器的功能，<span>称得上心律管理领域的革命性进化。</span></span></p><p><br  /></p><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="87844" data-color="#27939d"><section data-width="20em"><section><section><p data-brushtype="text"><strong><span>Micra Transcatheter&nbsp;Leadless Pacemaker System</span></strong></p></section></section><section></section></section></section><section data-role="paragraph" data-color="#27939d"><p><br  /></p></section></section><p><span>美敦力的Micra正是这样一款富有革命性创新基因的无导线起搏器，<span>Micra采用</span>镍钛合金制作，可在右心室内感知患者心脏的电活动，监测心动过缓心律并针对心动过缓提供起搏治疗。同时<span>Micra还</span>是一款磁共振环境条件安全的经导管植入式单腔起搏系统，在制造商规定的特定条件下，并保证对患者和植入设备采取了特殊保护措施的前提下，患者可接受临床1.5T和3.0T场强的磁共振成像全身检查</span><span>（不适用于局部发射线圈成像）</span><span>。</span></p><p><span><br  /></span></p><section><p><img src="image/20201014/e7df320059974ec8bd8071fb7046bacb_4.png" /></p></section><section><span>Micra经导管植入式无导线起搏系统示意图</span><span></span></section><p><br  /></p><p><span>Micra经导管植入式无导线起搏系统是目前</span><span><strong>世界上最小的心脏起搏器</strong></span><span>，长25.9毫米，体积1.0立方厘米，重量仅2克，体积比传统的心脏起搏器缩小90%，仅相当于一枚硬币的大小。</span></p><p><br  /></p><p><p><img src="image/20201014/ef762961c74dd81209b7071343baeb74_5.gif" /></p></p><p><br  /></p><p><span>另外，Micra能够通过股静脉穿刺的方式被输送至心腔后植入到右心室内，无需引线，微创介入手术的时间仅有传统起搏器植入手术的一半</span><span>（约30分钟）</span><span>，<span>相比传统起搏器，重大并发症减少约51%。</span>目前Micra是世界唯二的植入式无导线起搏系统，与雅培的Nanostim 起搏器遥相呼应。</span></p><p><br  /></p><p><p><img src="image/20201014/4eb137456b399810bd47d4214f4f9c38_6.gif" /></p></p><p><br  /></p><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="94325" data-color="#27939d"><section data-width="100%"><section data-width="100%"><section data-autoskip="1"><p><span><strong><span>Nanostim 起搏器</span></strong></span><span></span></p><p><span><strong><span><br  /></span></strong></span></p><p><span>Nanostim 起搏器最早由成立于加州 Sunnyvale 的 Nanostim 公司推出，在 2013 年获得 CE 认证后被 St. Jude 公司以 1.23 亿美元收购。随着雅培收购 St. Jude, Nanostim 无导线起搏器已成为雅培心律管理产品线中的一员。该起搏器呈棒状，大小约为 7 号电池，由可操纵导管经股静脉植入到右心室心尖部。Nanostim 起搏器虽然体积小，但寿命却不短于普通起搏器，在 100％ 起搏时可达 9.8 年。</span></p></section><section data-width="100%"></section></section></section></section><section data-role="paragraph" data-color="#27939d"><p><br  /></p></section></section><p><strong><span>编者按：</span></strong><span>Micra无导线起搏系统在2015年获得欧盟批准，2016年获得FDA批准，全球植入数已达20000余例，获得NMPA的审批后，必然能够加快我国对传统植入式心脏起搏器的替代，更会刺激如微创医疗、乐普医疗、先健科技等国内同类械企加快研发步伐，优化国产替代。</span></p><p><span><br  /></span></p><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="86032" data-color="#27939d"><section><section><p><strong><span data-brushtype="text">END</span></strong></p></section><section><section data-width="100%"></section></section></section></section><section data-role="paragraph" data-color="#27939d"><p><br  /></p></section></section><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph"><section><a data-miniprogram-appid="wxdc7efe409d688f37" data-miniprogram-path="pages/authorizationLogin/authorizationLogin" data-miniprogram-nickname="" href="" data-miniprogram-type="image" data-miniprogram-servicetype="" href=""><p><img src="image/20201014/2e25c809fffd6ef0866d70b58effc1a6_7.gif" 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