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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>据外媒报道，日前医疗器械巨头雅培公司宣布，其TriClip经导管三尖瓣修复系统在欧洲获得了CE 认证。据雅培描述，该系统是世界上第一个可以商业化使用的微创、卡夹式三尖瓣修复装置。</span></p><p><br /></p><p><p><img src="image/20201014/fba7af3e72129bacd7cb72628060b7c3_2.jpg" /></p></p><p><br /></p><p><span>TriClip（MitraClip）系统作为瓣叶边缘对合技术的代表，器械的原理是通过夹闭瓣叶进而降低功能性反流程度。该夹合器最早设计用于经导管治疗二尖瓣反流，由于该器械的可获取性和操作人员的对器械熟悉，已成为功能性三尖瓣反流高危患者的首选方法。据报道，目前全世界接受该器械治疗的患者占所有经导管治疗三尖瓣反流的患者的50%以上。</span></p><p><span><br /></span></p><p><span>2018年经导管心血管治疗学术会议（TCT 2018）公布了目前最大样本的TR介入治疗的TRIVALVE研究结果，该研究为注册、真实世界研究，共入选249例患者，结果提示MitraClipTR是安全可行、有效的。但实际操作中，由于三尖瓣解剖角度等原因，夹合器易出现定位困难，同时在严重继发性三尖瓣反流患者中扩张的三尖瓣环可致瓣叶裂隙宽且接合错位。</span></p><p><br /></p><p><p><img src="image/20201014/9fbd76826d4c537ce84920e5518464cc_3.jpg" /></p></p><p><br /></p><p><span>三尖瓣返流（TR）是一种重要但常被低估的心脏病。在西方国家高达90%的患者中，中度至重度TR是继发性或功能性的，最常见的原因是左侧心脏病和其他肺动脉高压。</span><span>如果不及时治疗，</span><span>TR会导致心房颤动，心力衰竭和死亡，</span><span>并且</span><span>它通常发生在老年患者的多发性共病中</span><span>，这</span><span>使心脏直视手术成为一种高风险的手术。</span><span> TriClip无需进行</span><span>心脏直视手术</span><span>即可修复三尖瓣。</span></p><p><br /></p><p><span>医疗人员将设备通过腿部股静脉传送到心脏，在那里它将三尖瓣小叶的一部分夹在一起以减少血液回流，从而使心脏更有效地泵送。</span></p><p><br /></p><p><p><img src="image/20201014/61619dfb0943e70db0e0affd9c90dad3_4.jpg" /></p></p><p><br /></p><p><span>“三尖瓣返流是一种高度流行，但很少治疗的疾病，这就是为什么这一批准是医疗界的一个重要里程碑，”雅培结构性心脏业务高级副总裁迈克尔戴尔在发布中说。“TriClip有可能填补治疗空白，改变医生帮助三尖瓣返流患者的方式。</span></p><p><br /></p><p><span>“我们基于剪辑的技术为临床医生提供了一种改变生命的、被证明是安全、简单和有效的选择，以治疗患有致残和危及生命疾病的患者。”</span></p><p><br /></p><p><span>雅培在一份新闻稿中说，其CE标志的批准是在使用TriClip检查边缘到边缘修复的关键性三聚铝研究的六个月积极数据的基础上进行的。研究表明，该装置降低了TR的严重程度，并与6个月时功能能力和生活质量的显著改善相关。</span></p><p><br /></p><p><span>“患有严重三尖瓣返流的患者病情非常严重，几乎没有治疗选择，”德国波恩大学医院心脏科主任、三尖瓣试验首席研究者Georg Nickenig博士说。“雅培的TriClip可以深刻地影响医生如何治疗这些病人。该疗法的数据证明了其安全性和性能、耐用性以及患者生活质量的提高。”</span></p><p><br /></p><p><span>资料来源：</span></p><p><span>https://www.massdevice.com/abbotts-triclip-tricuspid-valve-repair-system-lands-ce-mark/</span></p><p><span>https://www.escardio.org/Journals/E-Journal-of-Cardiology-Practice/Volume-16/Treatment-options-for-severe-functional-tricuspid-regurgitation-indications-techniques-and-current-challenges</span></p><p><br /></p><section 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发表于 2020-10-14 12:33:36