Medtronic plc, a global leader in medical technology, today announced a major advancement in its mission to transform critical care – the VitalFlow™ Extracorporeal Membrane Oxygenation (ECMO) System has officially received CE (Conformité Européenne) Mark approval in Europe. This milestone signals a significant leap forward in delivering seamless, life-saving support to the most fragile patients.
美敦力公司（Medtronic plc），全球醫療技術領域的領導者，今日宣佈在其轉變重症監護使命中取得了重要進展——VitalFlow™ 體外膜氧合（ECMO）系統已正式獲得歐洲 CE（Conformité Européenne）標誌批准。這一里程碑標誌着在爲最脆弱的患者提供無縫、挽救生命的支持方面邁出了重要的一步。
With the CE Mark secured, Medtronic now offers a simple, fully integrated ECMO portfolio in Europe, purpose-built to meet the complex and evolving demands of modern intensive care units..
獲得CE標誌後，美敦力現在在歐洲提供一個簡單、完全集成的ECMO產品組合，專爲滿足現代重症監護室複雜且不斷變化的需求而打造。
A Legacy of Innovation
創新的傳承
The roots of ECMO innovation trace back to the 1960s and 70s, when Dr. Robert Bartlett — widely regarded as the “father of ECMO” — pioneered heart-lung bypass research that laid the foundation for today’s life-sustaining systems. His vision led to the founding of MC3 Cardiopulmonary in 1991, a company dedicated to developing safe, high-performing ECMO technologies for both adult and pediatric patients..
ECMO創新的根源可以追溯到20世紀60年代和70年代，當時羅伯特·巴特利特博士——被廣泛認爲是“ECMO之父”——開創了心肺旁路研究，爲當今的生命支持系統奠定了基礎。他的願景促成了MC3心肺公司於1991年成立，該公司致力於爲成人和兒童患者開發安全、高性能的ECMO技術。
The VitalFlow ECMO technology is the most innovative technology to-date from the Medtronic acquisition of MC3 Cardiopulmonary. The acquisition marked the culmination of an eight-year partnership and distribution agreement with the Medtronic Cardiac Surgery business resulting in the introduction of seven new ECMO products in seven years.
VitalFlow ECMO技術是美敦力收購MC3心肺公司以來最具創新性的技術。此次收購標誌着與美敦力心臟外科業務長達八年的合作伙伴關係和分銷協議的圓滿結束，七年內推出了七款新的ECMO產品。
MC3 Cardiopulmonary consistently developed and manufactured differentiated, high-quality ECMO products, which were exclusively distributed by Medtronic prior to the acquisition. These products, including catheters and oxygenators, are distinguished by their ability to simplify therapy and enhance ease of use.
MC3心肺公司始終致力於開發和製造差異化、高品質的ECMO產品，在被收購之前，這些產品由美敦力獨家經銷。這些產品（包括導管和氧合器）以其簡化治療和提高易用性的能力而脫穎而出。
Additionally, the partnership has reliably supplied these long-term indicated products throughout the COVID pandemic and beyond. With the CE Mark for VitalFlow achieved June 2025, the company is now poised to redefine ECMO care across Europe..
此外，該合作伙伴關係在整個新冠疫情及之後的時間裏，一直可靠地供應這些長期指定的產品。隨着VitalFlow於2025年6月獲得CE認證，該公司現在準備重新定義歐洲的ECMO護理。
VitalFlow System: ECMO Reimagined
生命流系統：ECMO的重新構想
The VitalFlow System represents a new paradigm in ECMO therapy. Designed to simplify ICU operations, it brings performance, ease of use and adaptability to the forefront of patient care. Its intuitive interface empowers every ICU team member — regardless of experience level — to operate ECMO with confidence and precision..
VitalFlow系統代表了ECMO治療的新範式。它旨在簡化ICU的操作，將性能、易用性和適應性置於患者護理的前沿。其直觀的界面使每位ICU團隊成員——無論經驗水平如何——都能夠信心十足且精確地操作ECMO。
With high performance, simplicity, and a configurable, upgradeable architecture, VitalFlow ECMO is more than a system – it is smart, scalable, and built to support the future of critical care.
VitalFlow ECMO以其高性能、簡潔性和可配置、可升級的架構，不僅僅是一個系統——它是智能的、可擴展的，並且爲支持重症監護的未來而構建。
A Commitment to Patients
對患者的承諾
“The CE Mark for the VitalFlow ECMO System is a powerful reflection of how we bring the Medtronic Mission to life — by engineering technologies that restore health and extend life,” said Giuseppe Savoja, Western Europe senior business director for the Cardiac Surgery business, which is part of the Cardiovascular Portfolio at Medtronic.
“VitalFlow ECMO系統獲得CE標誌，這有力地體現了我們如何通過工程技術實現美敦力的使命——恢復健康，延續生命，”美敦力心血管產品組合中心臟外科業務的西歐高級業務總監朱塞佩·薩沃亞表示。
“VitalFlow ECMO is more than a system; it’s a step toward transforming how ECMO is delivered across Europe. By simplifying complexity and expanding access, we’re helping care teams focus on what matters most – saving lives and improving outcomes for critically ill patients.”.
“VitalFlow ECMO 不僅僅是一個系統；它是邁向改變 ECMO 在歐洲交付方式的重要一步。通過簡化複雜性並擴大使用範圍，我們正在幫助醫療團隊專注於最重要的事情——挽救生命並改善危重患者的治療效果。”
As the only company serving the entire heart care team – from cardiac surgeons to perfusionists – Medtronic continues to lead in heart valves, surgical ablation, left atrial appendage management (LAAM), revascularization, perfusion, cannulation technologies and ECMO therapies. This comprehensive approach empowers clinicians to deliver holistic, lifetime care for their patients..
作爲唯一一家爲整個心臟護理團隊服務的公司——從心臟外科醫生到灌注師——美敦力繼續在心臟瓣膜、手術消融、左心耳管理（LAAM）、血運重建、灌注、插管技術及ECMO療法領域保持領先地位。這種全面的方法使臨牀醫生能夠爲患者提供整體的、終身的護理。
“Clinicians in the ECMO space have evolving needs,” said Pieter Kappetein, Ph.D., M.D., chief medical officer, Cardiac Surgery, Medtronic. “With patients' diseases becoming more complex, there is a growing demand for innovative solutions such as the VitalFlow ECMO system. Clinicians expect more from Medtronic and we are uniquely positioned to meet these needs to better serve their patients.”.
“ECMO領域的臨牀醫生的需求在不斷變化，”美敦力心臟外科首席醫療官皮特·卡佩特恩博士說。“隨着患者疾病的複雜性增加，對創新解決方案（如VitalFlow ECMO系統）的需求也在不斷增長。臨牀醫生對美敦力有更高的期望，而我們有能力滿足這些需求，從而更好地服務他們的患者。”
About ECMO
關於ECMO
ECMO uses a pump and oxygenator outside of the body to take over the work of the heart and lungs to restore health and extend life to critically ill patients who might otherwise expire. ECMO is most often used for life-threatening heart or lung failure to allow the heart and/or lung to rest and heal.
體外膜肺氧合（ECMO）通過在體外使用泵和氧合器，接管心臟和肺的功能，爲病情危重、可能無法存活的患者恢復健康並延長生命。ECMO 最常用於治療危及生命的心臟或肺部衰竭，使心臟和/或肺得以休息和恢復。
It is also used as a bridge option to heart or lung transplantation or to further treatment such as heart assist device or left ventricular assist device (LVAD)..
它也被用作心臟或肺移植的過渡選項，或進一步治療的橋樑，如心臟輔助裝置或左心室輔助裝置 (LVAD)。
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。更有力的行動。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，通過尋找和發現解決方案，大膽攻克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——團結了遍佈150多個國家的95,000多名充滿熱情的員工。
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.
我們的技術和療法治療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需要幫助的人的願望，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 .
我們致力於推動以洞察力爲導向的護理、以人爲本的體驗以及爲我們的世界帶來更好的結果，對我們有更多期待吧。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。
www.Medtronic.com
www.美敦力.com
and follow Medtronic on
並關注美敦力
領英
.
。
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the U.S. Securities and Exchange Commission. Actual results may differ materially from anticipated results.
任何前瞻性陳述都受到風險和不確定性的影響，如美敦力向美國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。
Contacts:
聯繫人：
María Trenzado
瑪麗亞·特倫扎多
Communications
通信
Medtronic Western Europe
美敦力西歐
+34 653 30 47 20
+34 653 30 47 20
Becky Dvorak
貝琪·德沃夏克
Communications
通信
Medtronic Cardiac Surgery
美敦力心臟手術
+1-612-309-7149
+1-612-309-7149
Ryan Weispfenning
瑞安·魏斯芬寧
Investor Relations
投資者關係
Medtronic
美敦力
+1-763-505-4626
+1-763-505-4626