美敦力Evolut TAVI系统在欧洲获得扩展的再次TAVI适应症批准Medtronic Evolut TAVI systems receive expanded redo TAVI indication in Europe

动脉网2025-05-21

Medtronic plc, a global leader in healthcare technology, today announced it has received CE (Conformité Européenne) Mark for the expanded redo TAVI indication of the Evolut™ PRO+ and FX transcatheter ...

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This approval allows for the implantation of a new Evolut transcatheter aortic valve (TAV) inside any failed previously implanted TAV..美敦力公司（Medtronic plc），作为全球医疗技术的领导者，今天宣布其Evolut™ PRO+和FX经导管主动脉瓣植入（TAVI）系统已获得CE（欧洲合格认证）标志，适用于扩展的再次TAVI适应症。该批准允许在任何先前植入的失效TAV内部植入新的Evolut经导管主动脉瓣（TAV）。The redo TAVI procedure is indicated for patients suffering from severe aortic stenosis with the failure of any TAV, regardless of the manufacturer, and for those at high-risk for open-heart surgery.再次进行TAVI手术适用于任何制造商的TAV失败导致的严重主动脉瓣狭窄患者，以及那些开胸手术高风险的患者。'The CE Mark approval for the Evolut TAVI system's redo TAVI procedure is great news for physicians working in this field, but most importantly for patients with failing transcatheter heart valves, who now have a crucial new treatment option' said Professor Dan Blackman, consultant interventional cardiologist, Leeds Teaching Hospitals NHS Trust, United Kingdom.  'This minimally invasive procedure not only offers an alternative for patients at high risk for surgery but also underscores the commitment to improving outcomes and extending the benefits of TAVI therapy.”.“Evolut TAVI系统再次TAVI手术获得CE认证，这对该领域的医生来说是个好消息，但最重要的是，为那些经导管心脏瓣膜衰败的患者提供了一个关键的新治疗选择。”英国利兹教学医院NHS信托的顾问介入心脏病学教授丹·布莱克曼说道。“这种微创手术不仅为手术高风险患者提供了替代方案，还彰显了改善疗效和扩大TAVI疗法益处的承诺。”Severe aortic stenosis occurs when the aortic valve leaflets become stiff and thickened and have difficulty opening and closing, making the heart work harder to pump blood to the rest of the body. Severe aortic stenosis often reduces a patient's quality of life and limits their daily activities. If left untreated, patients with symptomatic severe aortic stenosis can die from heart failure in as little as two years..重度主动脉瓣狭窄是指主动脉瓣叶变得僵硬和增厚，难以正常开合，导致心脏必须更加努力地将血液泵送到身体其他部位。重度主动脉瓣狭窄常会降低患者的生活质量，并限制其日常活动。若不进行治疗，出现症状的重度主动脉瓣狭窄患者可能在短短两年内因心力衰竭而死亡。11“Redo TAVI indication builds upon the Evolut platform’s proven valve performance and durability to offer safe and reliable lifetime management options, providing physicians exceptional patient outcomes today, while maintaining important options for the future,” said Jorie Soskin, vice president and general manager, Structural Heart, which is part of the Cardiovascular Portfolio at Medtronic.“Redo TAVI适应症基于Evolut平台经过验证的瓣膜性能和耐用性，提供安全可靠的生命管理选择，在为患者提供卓越的当下治疗效果的同时，也为未来保留了重要的选择权，”美敦力心血管产品组合部门结构性心脏业务副总裁兼总经理Jorie Soskin表示。“This approval is a testament to Medtronic’s ongoing commitment to advance patient care and expand treatment options and access around the globe.”.“此次批准证明了美敦力持续致力于提升患者护理水平，并在全球范围内扩大治疗选择和获取途径。”In native (i.e., non-prosthetic) aortic valves, Evolut TAVI systems are currently indicated for implantation in symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate, and low) in the European Union and the United States.在本土（即非假体）主动脉瓣中，Evolut TAVI系统目前适用于欧盟和美国所有风险类别（极高危、高危、中危和低危）的症状性重度主动脉瓣狭窄患者。About Medtronic美敦力公司简介Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries.大胆思考。更大胆的行动。我们是美敦力。美敦力公司总部位于爱尔兰戈尔韦，是全球领先的医疗技术公司，通过寻找并发现解决方案，勇敢地应对人类面临的最严峻的健康问题。我们的使命——减轻病痛、恢复健康、延长生命——将遍布150多个国家的95,000多名充满热情的员工团结在一起。Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day.我们的技术和治疗方案涵盖70种健康状况，包括心脏设备、手术机器人、胰岛素泵、手术工具、患者监测系统等。凭借我们多元化的知识、无尽的好奇心和帮助所有有需要者的愿望，我们提供了创新的技术，每秒、每小时、每一天都在改变两个人的生活。Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit .我们将在赋能洞察力驱动的医疗、以人为本的体验以及为我们的世界带来更好的结果方面，给您带来更多的期待。在我们所做的一切中，我们正在创造非凡。欲了解有关美敦力的更多信息，请访问。www.Medtronic.comwww.美敦力.comand follow Medtronic on并关注美敦力LinkedIn领英.。Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.任何前瞻性陈述均受风险和不确定性的影响，如美敦力向证券交易委员会提交的定期报告中所述。实际结果可能与预期结果有重大差异。Contacts:联系人：Kimberly Powell金伯利·鲍威尔Public Relations公共关系+1-202-498-2601+1-202-498-2601Ryan Weispfenning瑞安·魏斯芬宁Investor Relations投资者关系+1-763-505-4626+1-763-505-462611Ross J Jr, Braunwald E. Aortic stenosis. Circulation. July 1968; 38(1 Suppl):61-67罗斯 J Jr，布劳恩瓦尔德 E。主动脉瓣狭窄。《循环》。1968年7月；38卷（1增刊）：61-67页。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.42.0","shortVersion":"4.42.0","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2537935180","isCrawlerRequest":true}