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 aortic valve implantation (TAVI) systems. 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），作爲全球醫療技術的領導者，今天宣佈其Evolut™ PRO+和FX經導管主動脈瓣植入（TAVI）系統已獲得CE（歐洲合格認證）標誌，適用於擴展的再次TAVI適應症。該批准允許在任何先前植入的失效TAV內部植入新的Evolut經導管主動脈瓣（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.
再次進行TAVI手術適用於任何製造商的TAV失敗導致的嚴重主動脈瓣狹窄患者，以及那些開胸手術高風險的患者。
'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系統再次TAVI手術獲得CE認證，這對該領域的醫生來說是個好消息，但最重要的是，爲那些經導管心臟瓣膜衰敗的患者提供了一個關鍵的新治療選擇。”英國利茲教學醫院NHS信託的顧問介入心臟病學教授丹·布萊克曼說道。“這種微創手術不僅爲手術高風險患者提供了替代方案，還彰顯了改善療效和擴大TAVI療法益處的承諾。”
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..
重度主動脈瓣狹窄是指主動脈瓣葉變得僵硬和增厚，難以正常開合，導致心臟必須更加努力地將血液泵送到身體其他部位。重度主動脈瓣狹窄常會降低患者的生活質量，並限制其日常活動。若不進行治療，出現症狀的重度主動脈瓣狹窄患者可能在短短兩年內因心力衰竭而死亡。
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“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適應症基於Evolut平臺經過驗證的瓣膜性能和耐用性，提供安全可靠的生命管理選擇，在爲患者提供卓越的當下治療效果的同時，也爲未來保留了重要的選擇權，”美敦力心血管產品組合部門結構性心臟業務副總裁兼總經理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.”.
“此次批准證明了美敦力持續致力於提升患者護理水平，並在全球範圍內擴大治療選擇和獲取途徑。”
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（即非假體）主動脈瓣中，Evolut TAVI系統目前適用於歐盟和美國所有風險類別（極高危、高危、中危和低危）的症狀性重度主動脈瓣狹窄患者。
About Medtronic
美敦力公司簡介
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.
大膽思考。更大膽的行動。我們是美敦力。美敦力公司總部位於愛爾蘭戈爾韋，是全球領先的醫療技術公司，通過尋找並發現解決方案，勇敢地應對人類面臨的最嚴峻的健康問題。我們的使命——減輕病痛、恢復健康、延長生命——將遍佈150多個國家的95,000多名充滿熱情的員工團結在一起。
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.
我們的技術和治療方案涵蓋70種健康狀況，包括心臟設備、手術機器人、胰島素泵、手術工具、患者監測系統等。憑藉我們多元化的知識、無盡的好奇心和幫助所有有需要者的願望，我們提供了創新的技術，每秒、每小時、每一天都在改變兩個人的生活。
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 .
我們將在賦能洞察力驅動的醫療、以人爲本的體驗以及爲我們的世界帶來更好的結果方面，給您帶來更多的期待。在我們所做的一切中，我們正在創造非凡。欲瞭解有關美敦力的更多信息，請訪問。
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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.
任何前瞻性陳述均受風險和不確定性的影響，如美敦力向證券交易委員會提交的定期報告中所述。實際結果可能與預期結果有重大差異。
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Ross J Jr, Braunwald E. Aortic stenosis. Circulation. July 1968; 38(1 Suppl):61-67
羅斯 J Jr，布勞恩瓦爾德 E。主動脈瓣狹窄。《循環》。1968年7月；38卷（1增刊）：61-67頁。