Medtronic plc, a global leader in healthcare technology, has received U.S. Food and Drug Administration (FDA) approval of its expanded Dystonia clinical labeling for Medtronic Deep Brain Stimulation (DBS). This approval reflects a shift from Humanitarian Device Exemption (HDE) status to full effectiveness labeling supported by clinical evidence, marking an important milestone for patients and clinicians..

医疗技术领域的全球领导者美敦力公司（Medtronic plc）已获得美国食品药品监督管理局（FDA）对其扩展的美敦力脑深部刺激（DBS）肌张力障碍临床标签的批准。这一批准标志着从人道主义设备豁免（HDE）状态转变为由临床证据支持的完全有效性标签，对患者和临床医生而言是一个重要的里程碑。

Dystonia is the third most common movement disorder affecting as many as 250,000 people in the U.S., and no cures and no treatments exist to reverse the course of the disorder.

肌张力障碍是第三大最常见的运动障碍，影响着美国多达25万人，目前尚无治愈方法，也无逆转该病进程的治疗手段。

1

1

Dystonia is characterized by involuntary muscle contractions that force certain parts of the body into repetitive, twisting movements or painful postures that may interfere with everyday functions like walking, sleeping, eating, and talking.

肌张力障碍的特征是不自主的肌肉收缩，迫使身体某些部位做出重复的、扭曲的动作或痛苦的姿势，可能干扰日常功能，如行走、睡眠、进食和说话。

For more than 20 years, Medtronic has advanced care for people with Dystonia, pioneering DBS for Dystonia since 2003 as a humanitarian use device (HUD) under an HDE.  The labeling approval includes management of chronic, intractable primary dystonia, including generalized dystonia, segmental dystonia of the head and neck, and cervical dystonia for adults and for primary generalized dystonia in patients ages 12 or older.

二十多年来，美敦力公司一直致力于推进肌张力障碍患者的护理，并自2003年起将脑深部刺激（DBS）作为人道主义使用器械（HUD）应用于肌张力障碍的治疗。其标签批准包括对慢性、难治性原发性肌张力障碍的管理，包括全身性肌张力障碍、头颈部节段性肌张力障碍和成人颈肌张力障碍，以及12岁及以上患者的原发性全身性肌张力障碍。

The expanded clinical labeling also provides physicians and patients with stronger evidence, clearer treatment pathways, and more predictable access..

扩展后的临床标签还为医生和患者提供了更有力的证据、更清晰的治疗路径以及更可预测的获取途径。

“Medtronic DBS therapy provides people with Dystonia a safe and effective non-destructive treatment that physicians can tailor with BrainSense™ technology, offering recharge and recharge-free options and the broadest conditional MRI access,” said Ashwini Sharan, chief medical officer, Medtronic Neuromodulation, which is part of the Medtronic Neuroscience Portfolio.

“美敦力的DBS疗法为患有肌张力障碍的人提供了一种安全有效的非破坏性治疗，医生可以利用BrainSense™技术进行个性化调整，提供可充电和免充电选项，并拥有最广泛的条件性MRI访问权限，”美敦力神经科学产品组合的一部分——美敦力神经调节部门的首席医疗官阿什温尼·沙兰表示。

“The clinical data show meaningful improvements in dystonia symptoms and quality of life in adult patients. DBS improved motor, disability, and severity scores across both groups, and reduced pain in adult patients — outcomes that can be truly life-changing.”.

“临床数据显示，成人患者的肌张力障碍症状和生活质量有显著改善。脑深部刺激术（DBS）提升了两组患者的运动、残疾和严重程度评分，并减轻了成人患者的疼痛——这些结果确实可以改变生活。”

Since 1987, Medtronic has served more than 200,000 patients with movement disorders and other indications in more than 70 countries with its life-changing DBS therapy

自1987年以来，美敦力公司通过其改变生命的脑深部刺激（DBS）疗法，已为70多个国家超过20万名患有运动障碍及其他适应症的患者提供服务。

2

2

. The expanded Dystonia clinical labeling builds upon decades of partnership with clinicians, ongoing investment in evidence generation, and Medtronic’s commitment to improving outcomes for people living with complex movement disorders.

扩展的肌张力障碍临床标签建立在与临床医生数十年的合作、持续的证据生成投资以及美敦力致力于改善复杂运动障碍患者预后的承诺之上。

About Medtronic

关于美敦力

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。更果敢的行动。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，大胆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.

我们的技术和治疗手段涵盖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、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基础的护理、以人为本的体验，以及为我们的世界创造更好的结果。在我们所做的一切中，我们正在创造非凡的工程。如需更多关于美敦力的信息，请访问。

www.Medtronic.com

www.美敦力.com

and follow us on

关注我们

LinkedIn

领英

.

。

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.

任何前瞻性陈述均受风险和不确定性的影响，例如美敦力向美国证券交易委员会提交的定期报告中所述的风险和不确定性。实际结果可能与预期结果有重大差异。

Medtronic DBS therapy is approved for five indications: Parkinson's disease, essential tremor, dystonia, obsessive-compulsive disorder* (OCD), and epilepsy. Indications vary by product. Refer to product labeling for details.

美敦力脑深部刺激疗法已获准用于五种适应症：帕金森病、特发性震颤、肌张力障碍、强迫症*（OCD）和癫痫。不同产品的适应症可能有所不同。详情请参阅产品标签。

*

*

Humanitarian device

人道主义援助设备

: The effectiveness of these devices for the treatment of obsessive-compulsive disorder has not been demonstrated.

这些设备治疗强迫症的有效性尚未得到证实。

References

参考文献

American Association of Neurological Surgeons. Dystonia. April 15, 2024. Accessed November 25, 2025. Available at: www.aans.org/patients/conditions-treatments/dystonia

美国神经外科医师协会。肌张力障碍。2024年4月15日。2025年11月25日访问。网址：www.aans.org/patients/conditions-treatments/dystonia

Medtronic data on file.

美敦力数据存档。

Media Contacts:

媒体联系人：

Naomi Rodiles

娜奥米·罗迪莱斯

Public Relations

公共关系

+1-612-427-5521

+1-612-427-5521

Ryan Weispfenning

瑞安·魏斯芬宁

Investor Relations

投资者关系

+1-763-505-4626

+1-763-505-4626