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），全球医疗技术领域的领导者，今日宣布在其转变重症监护使命中取得了重要进展——VitalFlow™ 体外膜氧合（ECMO）系统已正式获得欧洲 CE（Conformité Européenne）标志批准。这一里程碑标志着在为最脆弱的患者提供无缝、挽救生命的支持方面迈出了重要的一步。

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..

获得CE标志后，美敦力现在在欧洲提供一个简单、完全集成的ECMO产品组合，专为满足现代重症监护室复杂且不断变化的需求而打造。

A Legacy of Innovation

创新的传承

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创新的根源可以追溯到20世纪60年代和70年代，当时罗伯特·巴特利特博士——被广泛认为是“ECMO之父”——开创了心肺旁路研究，为当今的生命支持系统奠定了基础。他的愿景促成了MC3心肺公司于1991年成立，该公司致力于为成人和儿童患者开发安全、高性能的ECMO技术。

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技术是美敦力收购MC3心肺公司以来最具创新性的技术。此次收购标志着与美敦力心脏外科业务长达八年的合作伙伴关系和分销协议的圆满结束，七年内推出了七款新的ECMO产品。

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心肺公司始终致力于开发和制造差异化、高品质的ECMO产品，在被收购之前，这些产品由美敦力独家经销。这些产品（包括导管和氧合器）以其简化治疗和提高易用性的能力而脱颖而出。

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，该合作伙伴关系在整个新冠疫情及之后的时间里，一直可靠地供应这些长期指定的产品。随着VitalFlow于2025年6月获得CE认证，该公司现在准备重新定义欧洲的ECMO护理。

VitalFlow System: ECMO Reimagined

生命流系统：ECMO的重新构想

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系统代表了ECMO治疗的新范式。它旨在简化ICU的操作，将性能、易用性和适应性置于患者护理的前沿。其直观的界面使每位ICU团队成员——无论经验水平如何——都能够信心十足且精确地操作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、简洁性和可配置、可升级的架构，不仅仅是一个系统——它是智能的、可扩展的，并且为支持重症监护的未来而构建。

A Commitment to Patients

对患者的承诺

“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系统获得CE标志，这有力地体现了我们如何通过工程技术实现美敦力的使命——恢复健康，延续生命，”美敦力心血管产品组合中心脏外科业务的西欧高级业务总监朱塞佩·萨沃亚表示。

“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 不仅仅是一个系统；它是迈向改变 ECMO 在欧洲交付方式的重要一步。通过简化复杂性并扩大使用范围，我们正在帮助医疗团队专注于最重要的事情——挽救生命并改善危重患者的治疗效果。”

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..

作为唯一一家为整个心脏护理团队服务的公司——从心脏外科医生到灌注师——美敦力继续在心脏瓣膜、手术消融、左心耳管理（LAAM）、血运重建、灌注、插管技术及ECMO疗法领域保持领先地位。这种全面的方法使临床医生能够为患者提供整体的、终身的护理。

“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领域的临床医生的需求在不断变化，”美敦力心脏外科首席医疗官皮特·卡佩特恩博士说。“随着患者疾病的复杂性增加，对创新解决方案（如VitalFlow ECMO系统）的需求也在不断增长。临床医生对美敦力有更高的期望，而我们有能力满足这些需求，从而更好地服务他们的患者。”

About ECMO

关于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.

体外膜肺氧合（ECMO）通过在体外使用泵和氧合器，接管心脏和肺的功能，为病情危重、可能无法存活的患者恢复健康并延长生命。ECMO 最常用于治疗危及生命的心脏或肺部衰竭，使心脏和/或肺得以休息和恢复。

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)..

它也被用作心脏或肺移植的过渡选项，或进一步治疗的桥梁，如心脏辅助装置或左心室辅助装置 (LVAD)。

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。更有力的行动。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，通过寻找和发现解决方案，大胆攻克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——团结了遍布150多个国家的95,000多名充满热情的员工。

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.

我们的技术和疗法治疗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需要帮助的人的愿望，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 .

我们致力于推动以洞察力为导向的护理、以人为本的体验以及为我们的世界带来更好的结果，对我们有更多期待吧。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。