With this labeling approval, Medtronic continues to lead the way in advancing aortic care with clinical evidence for the treatment of ruptured abdominal aortic aneurysms (rAAA).

通过这一标签批准，美敦力继续通过治疗破裂性腹主动脉瘤（rAAA）的临床证据引领主动脉护理的进步。

Medtronic plc, a global leader in healthcare technology, today announced it has received U.S. Food and Drug Administration (FDA) labeling approval

美敦力公司（Medtronic plc），一家全球领先的医疗技术公司，今天宣布已获得美国食品药品监督管理局（FDA）的标签批准。

for the Medtronic Endurant™ stent graft system, by adding ruptured abdominal aortic aneurysm (rAAA) clinical evidence and removing the rAAA treatment warning. This FDA labeling approval makes Medtronic the first and only company to remove the rAAA warning from its stent graft system Instructions for Use (IFU), aligning innovation with real-world practices and training to empower physicians to act confidently in emergency cases..

对于美敦力Endurant™支架移植系统，通过增加破裂性腹主动脉瘤（rAAA）的临床证据并移除rAAA治疗警告。此次FDA标签批准使美敦力成为首家也是唯一一家从其支架移植系统使用说明（IFU）中移除rAAA警告的公司，将创新与现实实践和培训相结合，助力医生在紧急情况下自信应对。

A ruptured AAA is a critical condition in which the main artery in the abdomen bursts, causing severe internal bleeding and requiring emergency surgical intervention. The mortality rate from a ruptured abdominal aortic aneurysm is extremely high, exceeding 80%.

破裂的AAA是一种关键状况，其中腹部的主要动脉破裂，导致严重的内出血，并需要紧急手术干预。破裂的腹主动脉瘤的死亡率极高，超过80%。

“This landmark effort harnessed international, real-world data to evaluate the performance of endovascular devices in the treatment of ruptured abdominal aortic aneurysms (rAAA). The recent FDA labeling approval provides physicians with confidence in an endovascular treatment option for rAAA patients for the first time.” said Dr.

“这项具有里程碑意义的努力利用国际真实世界数据，评估了血管内设备在治疗破裂性腹主动脉瘤（rAAA）中的性能。最近FDA的标签批准首次为医生提供了对rAAA患者进行血管内治疗选择的信心。”博士说道。

Adam Beck, MD, FACS, director of the division of Vascular Surgery and Endovascular Therapy .

亚当·贝克，医学博士，FACS，血管外科和血管腔内治疗科主任。

the University of Alabama. “This milestone validates the importance of rAAA, enabling continued medical education and support for physicians to safely treat these complex, high-acuity cases.”

阿拉巴马大学。“这一里程碑验证了rAAA的重要性，使医生能够继续接受医学教育和支持，以安全治疗这些复杂、高敏锐度的病例。”

For over a decade, the Endurant stent graft system has been chosen by physicians to treat more than half a million patients worldwide.

十多年来，Endurant支架移植系统已被医生选中，用于治疗全球超过五十万名患者。

“This important FDA labeling approval is a testament to the innovation, durability, and effectiveness behind the Endurant stent graft system,” said Simona Zannetti, MD, vice president and general manager of Aortic, part of the Cardiovascular Portfolio at Medtronic. “We are proud to be the first company in the industry with the labeling approval to support treatment of rAAA, strengthening our ability to support physicians in confidently treating patients during critical emergencies.”.

“这一重要的FDA标签批准证明了Endurant支架移植系统的创新性、耐用性和有效性，”美敦力心血管产品组合中主动脉部门的副总裁兼总经理Simona Zannetti博士说道，“我们很自豪能够成为行业内首家获得用于支持rAAA治疗的标签批准的公司，这增强了我们在危急紧急情况下帮助医生自信地为患者提供治疗的能力。”

About the Endurant

关于Endurant

stent graft system is backed by over a decade of robust clinical evidence from the ENGAGE 10-year global registry to demonstrate safe and effective use.

支架移植物系统得到了超过十年的强大临床证据的支持，这些证据来自ENGAGE 10年全球注册研究，证明了其安全性和有效性。

Endurant stent graft system is designed to treat abdominal aortic aneurysms (AAA) using a minimally invasive endovascular aneurysm repair (EVAR). As the first and only EVAR system with a decade of global registry outcomes, Endurant systems continue to prove durability and strength in evidence with consistently high rates of sac regression and low aneurysm-related mortality (ARM)..

Endurant支架移植系统旨在通过微创的血管内动脉瘤修复术（EVAR）治疗腹主动脉瘤（AAA）。作为拥有十年全球注册结果的第一且唯一的EVAR系统，Endurant系统持续以证据证明其持久性和强度，始终保持较高的瘤囊退缩率和较低的动脉瘤相关死亡率（ARM）。

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——凝聚了遍布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。凭借我们多样化的知识、永无止境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 .

期待我们带来更多成果，因为我们致力于推动以洞察力为导向的护理、以人为本的体验，以及为我们的世界创造更好的结果。在我们所做的每一件事中，我们都在创造非凡的工程。欲了解有关美敦力的更多信息，请访问。