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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，捷迈邦美旗下的Medtech公司研发生产的手术机器人ROSA One通过了NMPA审核，正式登陆中国市场。注册型号为ROSA One，是目前国内唯一一款获批上市、并可同时应用于脑外科与脊柱外科手术导航机器人。由机器臂基座、摄像机基座、脚踏开关、导航工具及配件组成，用于在脑外科和脊柱外科手术中实现手术器械的定位。</span></p><p><br /></p><p><p><img src="image/20201014/a7eb2d377ce54ab6a5595efe4b4389ba_2.png" /></p></p><p><span>图：Rosa One Computer Assisted Surgical Device（来源：www.medtech.fr）</span></p><p><br /></p><p><span>捷迈邦美是全球骨科机器人“四大天王（美敦力、史赛克、施乐辉、捷迈邦美）”之一，2016年<span>捷迈邦美</span>以</span><span>不低于13.2亿美元的价格收购了<span>拥有</span><span>Rosa Brain和Rosa Spine机器人辅助手术平台的</span></span><span>法国手术机器人公司</span><span>Medtech</span><span>。</span></p><p><span></span></p><p><br /></p><p><p><img src="image/20201014/f8d94951a316f77d1342e301a3690e44_3.jpg" /></p></p><p><br /></p><p><span>在2019年第一季度，捷迈邦美获得FDA批准用于膝关节手术应用的Rosa平台和Rosa One Spine平台，并宣布计划在2019年中期将Rosa Knee正式进入膝关节市场。这一举措使得Zimmer Biomet成为第一个在手术机器人市场上获得脑、脊柱、膝关节FDA批准的公司。</span></p><p><span></span></p><p><br /></p><p><span><strong><span>Rosa One</span></strong></span><span></span></p><p><span><br /></span></p><p><span>Medtech被捷迈邦美纳入旗下后，在原有Rosa Brain和Rosa Spine的基础上，开发出新一代的Rosa One外科手术机器人系统。</span></p><p><span><br /></span></p><p><strong><span><span>ROSA Brain</span></span></strong><span><span></span></span></p><p><video width="100%" height="580" controls="controls"><source src="http://mpvideo.qpic.cn/0bf2heaaiaaa4eamult5pjpfaoodaq4qabaa.f10002.mp4?dis_k=42cd03fe157709d00e24e483e0067802&dis_t=1602650489" type="video/mp4"></source></video></p><p><span></span><br /></p><p><strong><span>ROSA Spine</span></strong></p><p><video width="100%" height="580" controls="controls"><source src="http://mpvideo.qpic.cn/0bf2muaakaaaiaamvcl5qrpfazodavsqabia.f10002.mp4?dis_k=2bbe81895b03ef7a6138bc420b2036f0&dis_t=1602650489" type="video/mp4"></source></video></p><p><br /></p><p><span>Rosa One的设计理念并非取代医生，而是作为医生的补充，创新的技术核心是采用了六度自由机械臂传感技术及精细的触觉反馈技术、复杂器械操作的软件程控技术、可视化导航功能、患者体位动态追踪技术，开创了脑外科/脊柱外科机器人手术技术的里程碑。</span></p><p><br /></p><p><p><img src="image/20201014/3784deadd743babf83d3ad4817d0595b_4.png" /></p></p><p><br /></p><p><span>ROSA已经成为脑外科手术机器人的代名词，在其成功基础之上，ROSA ONE：即ROSA 的第二代产品，将ROSA BRAIN 与 ROSA Spine结合于一体，其质量研发和验证体系完善，主要体现了“SAFE”的研发理念：S-稳(Stable)；A-精(Accurate)；F-灵(Flexible)；E-广(Extended)，将再次刷新行业标准，为临床提供安全可靠的保证。</span></p><p><br /></p><p><p><img src="image/20201014/099ca13e12f03bd371a5496cbd1b4bd2_5.png" /></p></p><p><br /></p><p><span>Ps：2019年2月11日，捷迈邦美宣布ROSA One Brain通过了FDA的审批，用于神经外科手术；同年3月25日，ROSA ONE Spine通过了FDA的审批，用于脊柱微创手术。</span></p><p><span><br /></span></p><p><br /></p><p><p><img src="image/20201014/f2d637123bd7cd696f83da12dd88c8d1_6.png" /></p></p><p><span>图：Rosa One Brain应用于神经外科手术（来源：网络）</span></p><p><br /></p><p><span>除了上线产品，Zimmer Biomet为快速打入市场做了很多努力，与苹果公司合作开发应用程序，针对特定的外科手术患者，为外科医生提供持续的临床数据和患者反馈，并提供针对特定程序的护理计划，为手术和术后康复做好最充分的准备。</span></p><p><br /></p><p><span>ROSA与史赛克的MAKO有针锋相对地竞争关系，MAKO与ROSA相比，二者几乎势均力敌，互有优缺。MAKO采用触觉引导系统，CT扫描定位，认为这样更加精准，但是这也造成了较大的辐射量与手术成本。ROSA使用X光定位，所需配准点的数量是MAKO的五分之一，但是需要借助夹具固定，手术侵入性更大。由于Zimmer Biomet在脑、脊柱、膝关节三大领域均拥有获得FDA批准的手术机器人，并且ROSA ONE Spine、ROSAOneBrain以及ROSAKnee可在同一平台系统使用，面向更多适应症并且具有高度通用性是Zimmer Biomet独一无二的优势。</span></p><p><br /></p><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_7.gif" /></p></section><section data-brushtype="text">戳一下，更有料！</section></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" 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发表于 2020-10-14 12:41:30