Medtronic plc, a global leader in healthcare technology, today announced that the Onyx™ Liquid Embolic System is now indicated in the United States for embolization of the middle meningeal artery (MMA) as an adjunct to surgery for the treatment of symptomatic subacute or chronic subdural hematoma (SDH).

美敦力公司（Medtronic plc），全球医疗技术的领导者，今天宣布Onyx™液体栓塞系统现在在美国被批准用于栓塞大脑膜中动脉（MMA），作为治疗症状性亚急性或慢性硬膜下血肿（SDH）手术的辅助手段。

This signals a significant step in cSDH patient treatment..

这标志着cSDH患者治疗的一个重要步骤。

About the New Indication

关于新适应症

The Medtronic-sponsored, multicenter, prospective and randomized EMBOLISE Trial compared MMAe using Onyx™ Liquid Embolic System (LES) as an adjunct to surgery with surgical management alone for symptomatic subacute and chronic SDH. Results from the EMBOLISE trial were initially presented at the 2024 International Stroke Conference and subsequently published in the New England Journal of Medicine in November 2024.

美敦力赞助的多中心、前瞻性、随机EMBOLISE试验比较了使用Onyx™液体栓塞系统（LES）作为手术辅助的MMA栓塞与单独手术治疗症状性亚急性和慢性SDH的效果。EMBOLISE试验的结果最初在2024年国际卒中会议上发表，随后于2024年11月发表在《新英格兰医学杂志》上。

The Onyx™ LES study demonstrated a decreased recurrence and re-operation of about 63% when combined with surgery. In addition, there were no Onyx™ device-related adverse events up to 180 days and no deaths attributed to Onyx™ LES or the MMAe procedure..

Onyx™ LES 研究表明，当与手术结合使用时，复发和再次手术的概率降低了约 63%。此外，在长达 180 天的时间里没有发生与 Onyx™ 设备相关的不良事件，也没有因 Onyx™ LES 或 MMAe 手术导致的死亡。

This expansion reflects Medtronic’s ongoing commitment to innovation, grounded in evidence and designed around safety and outcomes. Our dedicated Principal Investigators and research teams continue to analyze the EMBOLISE trial data, providing further insights to advance cSDH treatment.

这一扩展反映了美敦力公司对创新的持续承诺，以证据为基础，并围绕安全性和结果进行设计。我们专注的首席研究员和研究团队继续分析EMBOLISE试验数据，为推进cSDH治疗提供进一步的见解。

About cSDH

关于cSDH

cSDH, or chronic subdural hematoma, is a collection of blood between the brain’s dura and arachnoid mater that develops slowly over a period of days or weeks, usually following trauma. It commonly occurs in older people, and it can lead to severe complications if left untreated.

慢性硬膜下血肿（cSDH）是大脑硬膜与蛛网膜之间缓慢积聚的血液，通常在数天或数周内逐渐形成，常由头部创伤引发。它多见于老年人，若不及时治疗，可能导致严重并发症。

About the Neurovascular Business at Medtronic

美敦力神经血管业务相关

Medtronic helped create the neurovascular market – introducing innovations like liquid embolic, stent retrievers, and flow diverters. Today, with products covering multiple conditions and disease states, we work to eliminate the burden of stroke and other neurovascular diseases globally by transforming care, one breakthrough at a time.

美敦力帮助创建了神经血管市场——推出了诸如液体栓塞剂、支架取栓器和血流导向器等创新产品。如今，我们的产品覆盖多种病症和疾病状态，通过一次次突破性进展，努力减轻中风及其他神经血管疾病带来的全球负担，变革医疗护理。

Together with our partners, including physicians, hospitals, governments and patients, we’re expanding into new disease states and stages of care. Our unwavering focus on better outcomes fuels our drive to deliver life-changing therapies and transform the future of care for patients worldwide. For more information, follow Medtronic Neurovascular on .

与我们的合作伙伴，包括医生、医院、政府和患者一起，我们正在扩展到新的疾病状态和护理阶段。我们始终专注于更好的治疗效果，推动我们提供改变生命的疗法，为全球患者变革未来的医疗护理。欲了解更多信息，请关注美敦力神经血管。

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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 .

随着我们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，期待我们做得更多。在我们所做的每一件事中，我们都在创造非凡。欲了解有关美敦力公司的更多信息，请访问。

www.Medtronic.com

www.美敦力.com

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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：

Erika Winkels

埃丽卡·温克尔斯

Public Relations - Neurovascular

公共关系 - 神经血管

erika.winkels@medtronic.com

erika.winkels@medtronic.com

Ingrid Goldberg

英格丽德·戈德堡

Investor Relations

投资者关系

ingrid.goldberg@medtronic.com

ingrid.goldberg@medtronic.com