2020年最具创新性的18个医疗器械

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                    <section data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><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><p><br  /></p><section><span>最近Galien基金会宣布了其第14届美国大奖赛最具创新性医疗器械的提名名单。</span></section><section><br  /></section><section><span>今年，基金会选出26名“最佳药物产品”提名者，23名“最佳生物技术产品”提名者和18名“最佳医疗技术”提名者。</span></section><section><br  /></section><section><span>其中18名“最佳医疗技术”提名者来源从自眼科植入物到心脏瓣膜。根据Galien基金会的提名，以下是2020年18名“最佳医疗技术”提名者。</span></section><section><br  /></section><section><p><img src="image/20201014/8a09949dd661762e3014bfa20853b1b0_2.png" /></p></section><hr  /><section><br  /></section><section data-tools="gulangu" data-id="98855"><section data-tools="gulangu" data-id="97721"><section><section><section><section><p><img src="image/20201014/6481ecdea4fc8a70bc32f6b5f586c53f_3.png" /></p></section><section><p><span><strong>1</strong></span></p><p>MitraClip TMVR</p></section><section><p><img src="image/20201014/9ccba1a7a1463421e3b9ca2df4e4b121_4.png" /></p></section></section></section></section></section><section><br  /></section></section><section><span>MitraClip TMVR（二尖瓣经导管二尖瓣修复系统）源自雅培，MitraClip TMVR是目前唯一被FDA和NMPA批准应用于治疗二尖瓣病变的经导管瓣膜治疗的器械。</span></section><section><br  /></section><section><span>MitraClip TMVR也是雅培第一个经导管二尖瓣修复治疗二尖瓣返流，旨在为原发性或继发性二尖瓣返流患者提供一种治疗选择，否则将无法治疗。</span></section><section><br  /></section><section><span>MitraClip TMVR是一种微创的、基于导管的治疗方法，无需心脏直视手术。</span></section><section><br  /></section><section><p><img src="image/20201014/d2ae4248b1ac96065573a15b77d53a97_5.png" /></p></section><section><br  /></section><section data-tools="gulangu" data-id="98855"><section data-tools="gulangu" data-id="97721"><section><section><section><section><p><img src="image/20201014/6481ecdea4fc8a70bc32f6b5f586c53f_6.png" /></p></section><section><p><strong><span>2</span></strong></p><p>Venovo venous stent system</p></section><section><p><img src="image/20201014/9ccba1a7a1463421e3b9ca2df4e4b121_7.png" /></p></section></section></section></section></section><section><br  /></section></section><section><span>Venovo venous stent system源自碧迪，Venovo venous stent system设计用于精确地进行最佳支架放置和病变覆盖。它是专门为髂股静脉而设计。</span></section><section><br  /></section><section><span>Venovo venous stent system提供径向力，抗压和灵活性。它的特点是3毫米扩口支架末端，减少了支架移动的风险，同时最大限度地提高了壁面位置。</span></section><section><br  /></section><section><span>Venovo venous stent system用于各种尺寸髂股静脉，直径可达20mm，支架长度可达160mm。</span></section><section><br  /></section><section><p><img src="image/20201014/aa4c8d3aaee7e8c316e77c891dd6b295_8.jpg" /></p></section><section><br  /></section><section data-tools="gulangu" data-id="97721"><section><section><section><section><p><img src="image/20201014/6481ecdea4fc8a70bc32f6b5f586c53f_3.png" /></p></section><section><p><span><strong>3</strong></span></p><p>PK Papyrus covered coronary stent system</p></section><section><p><img src="image/20201014/9ccba1a7a1463421e3b9ca2df4e4b121_4.png" /></p></section></section></section></section></section><section><br  /></section><h2><span>PK Papyrus covered coronary stent system源自Biotronik，PK Papyrus covered coronary stent system是一种球囊扩张型覆膜支架，可通过球囊导管输送系统植入冠状动脉。</span></h2><section><br  /></section><h2><span>PK Papyrus covered coronary stent system设计用于治疗冠状动脉穿孔或心脏血管破裂。</span></h2><section><br  /></section><h2><span>PK Papyrus covered coronary stent system的输送球囊导管位于冠状动脉穿孔的位置。然后使球囊膨胀以扩张被覆盖的支架，将其压在冠状动脉壁上并密封穿孔，同时允许正常的血液流动。PK Papyrus covered coronary stent system永久性植入冠状动脉。</span></h2><section><br  /></section><section><p><img src="image/20201014/2c0fe5cff000cb295de712abe96f3602_11.png" /></p></section><section><br  /></section><section data-tools="gulangu" data-id="97721"><section><section><section><section><p><img src="image/20201014/6481ecdea4fc8a70bc32f6b5f586c53f_3.png" /></p></section><section><p><strong><span>4</span></strong></p><p>Axios stent and electrocautery-enhanced delivery system</p></section><section><p><img src="image/20201014/9ccba1a7a1463421e3b9ca2df4e4b121_4.png" /></p></section></section></section></section></section><section><br  /></section><section><span>Axios stent and electrocautery-enhanced delivery system源自波士顿科学，Axios stent and electrocautery-enhanced delivery system是一种消化内科支架，可用于有症状的胰腺假性囊肿的经胃或经十二指肠内镜引流。</span></section><section><br  /></section><section><span>Axios stent and electrocautery-enhanced delivery system将介入导管与Axios支架相结合。Axios stent and electrocautery-enhanced delivery system在内窥镜和内窥镜超声联合引导下使用，以使平滑，有效地进入病灶区域。</span></section><section><br  /></section><section><p><img src="image/20201014/8c9f67ec617c8d8d9d76dacca51c9aac_14.png" /></p></section><section><br  /></section><section data-tools="gulangu" data-id="97721"><section><section><section><section><p><img src="image/20201014/6481ecdea4fc8a70bc32f6b5f586c53f_3.png" /></p></section><section><p><strong><span>5</span></strong></p><p>HeartLogic heart failure diagnostic</p></section><section><p><img src="image/20201014/9ccba1a7a1463421e3b9ca2df4e4b121_4.png" /></p></section></section></section></section></section><section><br  /></section><section><span>HeartLogic heart failure diagnostic源自波士顿科学，HeartLogic heart failure diagnostic是一款个性化的远程心力衰竭诊断和监视器械。</span></section><section><br  /></section><section><span>HeartLogic heart failure diagnostic使用具有高灵敏度和低警报负担的生理传感器来提前数周通知患者，以及早发现心力衰竭恶化的早期迹象。</span></section><section><br  /></section><section><p><img src="image/20201014/ee6e7004be7caddcda4d3cc7ca47b17b_17.jpg" /></p></section><section><br  /></section><section><br  /></section><section data-tools="gulangu" data-id="97721"><section><section><section><section><p><img src="image/20201014/6481ecdea4fc8a70bc32f6b5f586c53f_6.png" /></p></section><section><p><strong><span>6</span></strong></p><p>Sentinel cerebral protection system</p></section><section><p><img src="image/20201014/9ccba1a7a1463421e3b9ca2df4e4b121_4.png" /></p></section></section></section></section></section><section><br  /></section><section><span>Sentinel cerebral protection system源自波士顿科学，Sentinel cerebral protection system是一种经皮输送的双过滤栓塞保护装置，旨在捕获和清除在血管内手术过程中排出的血栓等物质。</span></section><section><br  /></section><section><span>Sentinel cerebral protection system特点是带有可展开的近端和远端过滤器的6 Fr导管，一个铰接鞘和一个一体式手柄组件。</span></section><section><br  /></section><section><p><img src="image/20201014/c5d45ebc8649a1aeba629c52c416ce23_20.png" /></p></section><section><br  /></section><section><br  /></section><section data-tools="gulangu" data-id="97721"><section><section><section><section><p><img src="image/20201014/6481ecdea4fc8a70bc32f6b5f586c53f_3.png" /></p></section><section><p><span><strong>7</strong></span></p><p>Cala Trio</p></section><section><p><img src="image/20201014/9ccba1a7a1463421e3b9ca2df4e4b121_4.png" /></p></section></section></section></section></section><section><br  /></section><section data-role="outer"><section><br  /></section></section><section><br  /></section><section><span>Cala Trio源自Cala Health，Cala Trio是针对严重震颤的个性化疗法。Cala Trio属于非侵入性靶向治疗，专门设计用于帮助减轻患者的手部震颤的。</span></section><section><br  /></section><section><span>Cala Trio可测量特定的震颤，并向行进到大脑的内侧和radial神经发送轻微刺激。刺激中断了大脑一部分丘脑腹侧中间核的震颤。Cala Trio是处方性质的医疗器械。</span></section><section><br  /></section><section><p><img src="image/20201014/6cd01fe156a4ddb751625d1f8cca006b_23.png" /></p></section><section><br  /></section><section data-tools="gulangu" data-id="97721"><section><section><section><section><p><img src="image/20201014/6481ecdea4fc8a70bc32f6b5f586c53f_3.png" /></p></section><section><p><strong><span>8</span></strong></p><p>CustomFlex artificial iris</p></section><section><p><img src="image/20201014/9ccba1a7a1463421e3b9ca2df4e4b121_4.png" /></p></section></section></section></section></section><section><br  /></section><section><span>CustomFlex artificial iris源自HumanOptics，CustomFlex artificial iris是一种可折叠的虹膜假体，用于完全或部分无虹膜的眼睛的医学和美学重建，即完全或部分不存在眼睛的彩色部分。</span></section><section><br  /></section><section><span>CustomFlex artificial iris是定制化器械，可模仿患者虹膜的原始外观。它能够受控的光入射，具有固定的瞳孔和不透明材料。</span></section><section><br  /></section><section><p><img src="image/20201014/900ff4fa524dad0ba67d434158c5de61_26.jpg" /></p></section><section><br  /></section><section data-tools="gulangu" data-id="97721"><section><section><section><section><p><img src="image/20201014/6481ecdea4fc8a70bc32f6b5f586c53f_3.png" /></p></section><section><p><strong><span>9</span></strong></p><p>Sapien 3 Ultra transcatheter heart valve system</p></section><section><p><img src="image/20201014/9ccba1a7a1463421e3b9ca2df4e4b121_4.png" /></p></section></section></section></section></section><section><br  /></section><section><span>Sapien 3 Ultra transcatheter heart valve system源自爱德华，Sapien 3 Ultra transcatheter heart valve system用于缓解因严重的天然钙化主动脉瓣狭窄而导致的症状性心脏病主动脉瓣狭窄患者。</span></section><section><br  /></section><section><span>Sapien 3 Ultra transcatheter heart valve system设计用于可能被认为是中等风险或更高风险的心脏直视手术患者。</span></section><section><span><br  /></span></section><section><p><img src="image/20201014/c102219bc8b1205e0c66b0859a979df7_29.jpg" /></p></section><section><br  /></section><section data-tools="gulangu" data-id="97721"><section><section><section><section><p><img src="image/20201014/6481ecdea4fc8a70bc32f6b5f586c53f_3.png" /></p></section><section><p><span><strong>10</strong></span></p><p>Inspiris Resilia aortic valve</p></section><section><p><img src="image/20201014/9ccba1a7a1463421e3b9ca2df4e4b121_4.png" /></p></section></section></section></section></section><section><br  /></section><h2><span>Inspiris Resilia aortic valve源自爱德华，Inspiris Resilia aortic valve是一种带斑点的三叶瓣，由安装在柔性支架上的Resilia牛心包组织组成。</span></h2><section><br  /></section><h2><span>Inspiris Resilia aortic valve旨在提供增强的组织抗钙化技术，以允许瓣膜持续更长的时间。它具有Perimount Magma缓动阀，并包含爱德华专有的固定技术。</span></h2><section><br  /></section><section><p><img src="image/20201014/973293be0875a5a3e1e141065c05d33c_32.jpg" /></p></section><section><br  /></section><section data-tools="gulangu" data-id="97721"><section><section><section><section><p><img src="image/20201014/6481ecdea4fc8a70bc32f6b5f586c53f_3.png" /></p></section><section><p><strong><span>11</span></strong></p><p>Magtrace and Sentimag magnetic localization system</p></section><section><p><img src="image/20201014/9ccba1a7a1463421e3b9ca2df4e4b121_4.png" /></p></section></section></section></section></section><section><br  /></section><section><span>Magtrace and Sentimag magnetic localization system源自Endomag，Magtrace and Sentimag magnetic localization system是一种磁性设备系统，用于为患有乳腺切除术的乳腺癌患者提供淋巴结活检指导。</span></section><section><br  /></section><section><span>Magtrace and Sentimag magnetic localization system包括Magtrace注射式磁示踪剂以及Sentimag磁感测探针和基本单元。它有助于前哨淋巴结活检，以确定癌症是否已经扩散到其最初的肿瘤部位之外。</span></section><section><br  /></section><section><p><img src="image/20201014/af7ce479c451b3b41da678745142f58b_35.jpg" /></p></section><section><br  /></section><section><br  /></section><section data-tools="gulangu" data-id="97721"><section><section><section><section><p><img src="image/20201014/6481ecdea4fc8a70bc32f6b5f586c53f_3.png" /></p></section><section><p><strong><span>12</span></strong></p><p>iStent inject</p></section><section><p><img src="image/20201014/9ccba1a7a1463421e3b9ca2df4e4b121_4.png" /></p></section></section></section></section></section><section><br  /></section><section><span>iStent inject源自Glaukos，iStent inject是一种眼植入物，设计用于白内障手术，以减轻轻度至中度原发性开角型青光眼成年人的眼压。</span></section><section><br  /></section><section><span>iStent inject通过小梁网创建两个旁路通道，以通过Schlemm的管进行多方向流动。</span></section><section><br  /></section><section><p><img src="image/20201014/3785e578bc2c14b5ca8d7dca8c618a5a_38.png" /></p></section><section><br  /></section><section data-tools="gulangu" data-id="97721"><section><section><section><section><p><img src="image/20201014/6481ecdea4fc8a70bc32f6b5f586c53f_3.png" /></p></section><section><p><span><strong>13</strong></span></p><p>CCM therapy for heart failure</p></section><section><p><img src="image/20201014/9ccba1a7a1463421e3b9ca2df4e4b121_4.png" /></p></section></section></section></section></section><section><br  /></section><section><span>CCM therapy for heart failure源自Impulse Dynamics，CCM therapy for heart failure是一种微创的可植入设备，可用于治疗中度至重度充血性心力衰竭（CHF）症状的患者。</span></section><section><br  /></section><section><span>CCM therapy for heart failure提供精确定时的电脉冲，使患者的CHF症状减轻。</span></section><section><br  /></section><section><p><img src="image/20201014/93a826793e1be2417fd4ed208559aeaa_41.jpg" /></p></section><section><br  /></section><section><br  /></section><section data-tools="gulangu" data-id="97721"><section><section><section><section><p><img src="image/20201014/6481ecdea4fc8a70bc32f6b5f586c53f_3.png" /></p></section><section><p><span><strong>14</strong></span></p><p>Implantable system for Remodulin and HeartWare HVAD</p></section><section><p><img src="image/20201014/9ccba1a7a1463421e3b9ca2df4e4b121_4.png" /></p></section></section></section></section></section><section><br  /></section><section><span>Implantable system for Remodulin 和 HeartWare HVAD源自美敦力，Implantable system for Remodulin 和 HeartWare HVAD是一种左心室辅助设备，旨在辅助心脏并增加通过身体泵送的血液量。</span></section><section><br  /></section><section><span>HeartWare HVAD在其整个生命周期中都经历过召回事件，包括由于电池充电器而在今年3月发布的最新I类召回事件。Remodulin的可植入系统是一种输注系统，已完全植入患者体内以通过静脉输送Remodulin。</span></section><section><br  /></section><section><span>Remodulin通常用于治疗肺动脉高压。Remodulin的可植入系统包括Medtronic SynchroMed II 8637P可编程泵，带有8870应用卡的Medtronic N'Vision 8840临床医生编程器和Medtronic 8201可植入80厘米血管内导管。</span></section><section><br  /></section><section><p><img src="image/20201014/5d7954cd3191de027a48f40b20ea6319_44.jpg" /></p></section><section><br  /></section><section data-tools="gulangu" data-id="97721"><section><section><section><section><p><img src="image/20201014/6481ecdea4fc8a70bc32f6b5f586c53f_3.png" /></p></section><section><p><span><strong>15</strong></span></p><p>reSET&nbsp;和&nbsp;reSET-O</p></section><section><p><img src="image/20201014/9ccba1a7a1463421e3b9ca2df4e4b121_4.png" /></p></section></section></section></section></section><section><br  /></section><section><span>reSET 和 reSET-O源自Pear Therapeutics，reSET是针对药物滥用疾病的90天处方数字疗法。reSET提供认知行为疗法，作为对18岁以上且已接受门诊治疗的患者进行应急管理的补充。</span></section><section><br  /></section><section><span>reSET-O是用于阿片类药物使用障碍的84天处方数字治疗剂。reSET-O旨在通过提供认知行为疗法作为包括透粘膜丁丙诺啡和应急管理在内的门诊治疗的补充，从而增加患者在门诊治疗中的保留率。</span></section><section><br  /></section><section><span>reSET 和 reSET-O均具有相关的仪表板，供临床医生和其他医疗服务提供者查看有关患者使用系统的信息，包括完成的课程，患者报告的药物使用，患者报告的渴望和触发因素，患者报告的药物使用，依从性奖励以及 -临床数据输入。</span></section><section><br  /></section><section><p><img src="image/20201014/dc616959e73149d9cc93f7164b4097f7_47.png" /></p></section><section><br  /></section><section data-tools="gulangu" data-id="97721"><section><section><section><section><p><img src="image/20201014/6481ecdea4fc8a70bc32f6b5f586c53f_3.png" /></p></section><section><p><span><strong>16</strong></span></p><p>Zephyr endobronchial valve system</p></section><section><p><img src="image/20201014/9ccba1a7a1463421e3b9ca2df4e4b121_4.png" /></p></section></section></section></section></section><section><br  /></section><section><span>Zephyr endobronchial valve system源自Pulmonx，Zephyr endobronchial valve system是一种可植入的设备，用于减少由于成年人严重的肺气肿而导致的肺部过度充气。</span></section><section><br  /></section><section><span>Zephyr endobronchial valve system具有一个单向硅胶鸭嘴阀，该阀连接到镍钛自膨胀式定位器，并用硅胶膜覆盖。医生可以使用柔性支气管镜植入该设备，然后将其通过气道引导至肺部患病区域，以使肺部健康部分扩张并减少呼吸急促。当患者吸气时，阀门会关闭并阻止空气进入受损的肺部。</span></section><section><br  /></section><section><p><img src="image/20201014/f9282f094e26d79c9af754b0f3731b6a_50.png" /></p></section><section><br  /></section><section data-tools="gulangu" data-id="97721"><section><section><section><section><p><img src="image/20201014/6481ecdea4fc8a70bc32f6b5f586c53f_3.png" /></p></section><section><p><span><strong>17</strong></span></p><p>GentleWave system</p></section><section><p><img src="image/20201014/9ccba1a7a1463421e3b9ca2df4e4b121_4.png" /></p></section></section></section></section></section><section><br  /></section><section><span>GentleWave system源自Sonendo，GentleWave system是根管治疗的微创选择。GentleWave system利用先进的流体动力学，广谱声能和加速化学作用来提供对根管系统的清洁和消毒。</span></section><section><br  /></section><section><p><img src="image/20201014/0c40ea24edb21682e21ba1a4b08cee62_53.png" /></p></section><section><br  /></section><section data-tools="gulangu" data-id="97721"><section><section><section><section><p><img src="image/20201014/6481ecdea4fc8a70bc32f6b5f586c53f_3.png" /></p></section><section><p><span><strong>18</strong></span></p><p>ProAir Digihaler</p></section><section><p><img src="image/20201014/9ccba1a7a1463421e3b9ca2df4e4b121_4.png" /></p></section></section></section></section></section><section><br  /></section><section><span>ProAir Digihaler源自Teva Pharmaceuticals，ProAir Digihaler是一款数字救生吸入器，带有内置传感器，可检测吸入器的使用并测量吸气量。</span></section><section><br  /></section><section><span>当患者吸气时，来自吸入器的数据会记录为事件，并通过蓝牙发送至随附的智能手机应用程序，然后患者可以查看信息以与医疗保健提供者共享。</span></section><p><br  /></p><p><p><img src="image/20201014/f6aac4af924abd583a36286581beef47_56.png" /></p></p><p><br  /></p><p><span>来源：MedTF</span></p><p><br  /></p><section><section data-color="#757576"><section><section><section 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