For the one million people diagnosed with Parkinson's disease in the United States1, Medtronic plc (NYSE:MDT), a global leader in healthcare technology, proudly announces U.S. Food and Drug Administration (FDA) approval of BrainSense™ Adaptive deep brain stimulation (aDBS) and BrainSense™ Electrode Identifier (EI).

针对美国100 万被诊断患有帕金森病的患者1，全球医疗技术领导者美敦力公司 (NYSE:MDT) 自豪地宣布美国食品药品监督管理局 (FDA) 批准 BrainSense™ 自适应深部脑刺激 (aDBS) 和 BrainSense™ 电极识别器 (EI)。

There is no cure for debilitating neurological conditions like Parkinson's, however, deep brain stimulation (DBS) has been transforming the lives of people with Parkinson's and other neurological disorders for more than 30 years. DBS is similar to a cardiac pacemaker, but for the brain. It uses a surgically implanted neurostimulator via a minimally invasive procedure to transmit electrical signals to specific parts of the brain affected by debilitating neurological disorders.

帕金森病等神经衰弱症目前尚无治愈方法，但 30 多年来，深部脑刺激 (DBS) 一直在改变帕金森病和其他神经系统疾病患者的生活。DBS 类似于心脏起搏器，但作用于大脑。它使用通过微创手术植入的神经刺激器将电信号传输到受神经衰弱症影响的大脑特定部位。

Now Medtronic has enhanced its Percept™ DBS neurostimulators with exclusive BrainSense™ Adaptive technology†, introducing aDBS for people living with Parkinson's. This feature personalizes therapy based on a patient's brain activity in real time – both in clinical settings and in daily life2. It provides enhanced therapy personalization for symptom control that automatically adjusts, minimizing the need for patients to manually adjust stimulation.

现在，美敦力公司通过独有的 BrainSense™ Adaptive 技术†增强了其 Percept™ DBS 神经刺激器，为帕金森患者推出了 aDBS。该功能可根据患者的实时大脑活动对治疗进行个性化——无论是在临床环境还是在日常生活中2。它为症状控制提供了增强的治疗个性化，可自动调整，最大限度地减少了患者手动调整刺激的需要。

"Medtronic is the only company in the world to offer an adaptive DBS system that dynamically adjusts therapy in real time," said Brett Wall, executive vice president and president of the Medtronic Neuroscience Portfolio. "This new era in Parkinson's care represents more than a decade of intentional innovation—ushering in personalized neuromodulation at scale that responds to a patient's changing needs, equipping clinicians with unparalleled insights, and setting a new standard for DBS therapy."

美敦力执行副总裁兼神经科学产品线总裁 Brett Wall 表示：“美敦力是全球唯一一家提供自适应 DBS 系统的公司，该系统可实时动态调整治疗。帕金森病治疗的新时代代表了十多年的创新——大规模引入个性化神经调节，以响应患者不断变化的需求，为临床医生提供无与伦比的洞察力，并为 DBS 治疗树立新标准。”

For more than ten years, Medtronic has been developing a complete, sensing-enabled DBS system leveraging exclusive BrainSense™ technology to detect, capture, and classify different brain signals, putting Medtronic at the forefront of incorporating brain-computer interface (BCI) technology into DBS therapy. Medtronic considers BCI technology a crucial element for developing innovative products that treat some of the cardinal symptoms of Parkinson's with specific focus on rehabilitation and restoring health. BrainSense™ Adaptive DBS is available to Medtronic DBS patients with Parkinson's who have been implanted with a Percept™ neurostimulator, as well as future Medtronic DBS patients. With more than 40,000 DBS patients served worldwide3 with Medtronic Percept™ devices, BrainSense™ Adaptive DBS presents the largest commercial launch (by several magnitudes) of BCI technology – ever.

十多年来，美敦力一直致力于开发完整的、具有感知功能的 DBS 系统，该系统利用独有的 BrainSense™ 技术检测、捕获和分类不同的脑信号，使美敦力在将脑机接口 (BCI) 技术融入 DBS 治疗方面处于领先地位。美敦力认为 BCI 技术是开发创新产品的关键要素，这些产品可治疗帕金森氏症的一些主要症状，并特别注重康复和恢复健康。BrainSense™ 自适应 DBS 适用于已植入 Percept™ 神经刺激器的美敦力 DBS 帕金森氏症患者，以及未来的美敦力 DBS 患者。全球已有超过 40,000 名 DBS 患者3使用美敦力 Percept™ 设备，BrainSense™ 自适应 DBS 是有史以来规模最大的 BCI 技术商业发布（相差几个数量级）。

"Adaptive deep brain stimulation will help revolutionize the approach to therapeutic treatment for patients with Parkinson's disease," said Helen Bronte-Stewart MD MSE, FAAN, FANA, John E. Cahill Family Professor in the department of Neurology and Neurological Sciences and Director of the Human Motor Control and Neuromodulation Lab at Stanford University School of Medicine. "The transformative personalized care we can achieve through automatic adjustment greatly benefits patients receiving therapy that adapts to their evolving needs."

斯坦福大学医学院神经病学和神经科学系 John E. Cahill Family 教授、人体运动控制和神经调节实验室主任 Helen Bronte-Stewart 医学博士、理学硕士 (MSE)、美国神经病学会院士 (FAAN)、美国神经病学会院士 (FANA) 表示：“自适应深部脑刺激将有助于彻底改变帕金森病患者的治疗方法。我们可以通过自动调整实现变革性的个性化护理，这将极大地惠及接受适应其不断变化的需求的治疗的患者。”

The Medtronic Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) trial highlights the potential of aDBS in clinical practice. Dr. Bronte-Stewart served as the global principal investigator for the trial, which was conducted as an international, multi-center, prospective, single-blind, randomized crossover study (between two modes of aDBS), and evaluated the safety and effectiveness of chronic dual- and single-threshold aDBS modes compared to continuous DBS (cDBS) for eligible patients with Parkinson's disease receiving DBS therapy. This study represents the largest and longest assessment of aDBS conducted in both clinical and home settings and was developed in collaboration with more than a dozen world-renowned neurologists and neurosurgeons from leading academic institutions across the globe including Stanford University School of Medicine, University of California San Francisco, Massachusetts General Hospital and Amsterdam University Medical Center. The study methodology and sensing data from the study were published in npj Parkinson's Disease(opens new window), a journal within the prestigious Nature Portfolio.

美敦力帕金森病个性化治疗自适应 DBS 算法 (ADAPT-PD) 试验凸显了 aDBS 在临床实践中的潜力。Bronte-Stewart 博士担任该试验的全球首席研究员，该试验是一项国际、多中心、前瞻性、单盲、随机交叉研究（在两种 aDBS 模式之间进行），并评估了慢性双阈值和单阈值 aDBS 模式与连续 DBS (cDBS) 相比对接受 DBS 治疗的帕金森病患者的安全性和有效性。这项研究是在临床和家庭环境中进行的规模最大、时间最长的 aDBS 评估，是与来自全球领先学术机构的十多位世界知名神经病学家和神经外科医生合作开发的，包括斯坦福大学医学院、加州大学旧金山分校、麻省总医院和阿姆斯特丹大学医学中心。研究方法和传感数据发表在npj Parkinson's Disease上（打开新窗口），是著名的《自然》系列杂志中的一个期刊。

"For patients who struggle with motor symptom fluctuations, dyskinesias, and other side effects with cDBS, aDBS may offer improved symptom control," said Todd Herrington, MD, PhD, director of the Deep Brain Stimulation Program at Massachusetts General Hospital, assistant professor of neurology at Harvard Medical School, and investigator for the ADAPT-PD trial. "Approval of this therapy represents an important step forward for patients and I look forward to seeing the ADAPT-PD study results published soon."

麻省总医院深部脑刺激项目主任、哈佛医学院神经病学助理教授、ADAPT-PD 试验研究员Todd Herrington医学博士表示：“对于那些因 cDBS 而出现运动症状波动、运动障碍和其他副作用的患者，aDBS 可能能够更好地控制症状。这项疗法的获批对患者而言是向前迈出的重要一步，我期待 ADAPT-PD 研究结果早日公布。”

"Our BrainSense technology provides unique and clinically important insights that no other DBS system can offer, using a person's own brain signals to provide a window into their condition, in real time, over time," said Paolo Di Vincenzo, president of the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. "Our focus has always been on creating solutions that work for real lives, not just standalone symptoms. aDBS reflects that commitment, bringing a new expectation in Parkinson's treatment."

美敦力神经科学产品组合下属的神经调节业务总裁Paolo Di Vincenzo表示：“我们的 BrainSense 技术提供了其他 DBS 系统无法提供的独特且具有临床重要性的见解，它使用患者自己的脑信号，实时、随时间推移地提供了解其病情的窗口。我们一直专注于创造适用于现实生活的解决方案，而不仅仅是针对独立症状。aDBS 体现了这一承诺，为帕金森病治疗带来了新的期望。”

The U.S. FDA approval also includes the Medtronic BrainSense™ Electrode Identifier (EI), which helps reduce patient time spent in clinic to program their DBS settings. By using EI, clinicians can conduct an accurate and precise initial programming, 85% faster compared to traditional electrode selection

美国 FDA 的批准还包括美敦力 BrainSense™ 电极识别器 (EI)，它有助于减少患者在诊所编程 DBS 设置的时间。通过使用 EI，临床医生可以进行准确而精确的初始编程，与传统电极选择相比，速度提高了 85%。

"BrainSense™ Electrode Identifier offers less ambiguity and greater efficiency compared to the traditional method of electrode selection by providing a personalized, real-time snapshot of a patient's brain signals, which can help provide insights into the proximal sweet spot for programming. This new method reduces initial contact selection time, streamlining the process and ensuring more precise, tailored therapy for each patient," said Drew Kern, MD, MS, neurologist and associate professor of neurology at the University of Colorado School of Medicine.

科罗拉多大学医学院神经病学家、神经病学副教授 Drew Kern 医学博士、理科硕士表示：“BrainSense™ 电极识别器通过提供患者脑信号的个性化实时快照，与传统的电极选择方法相比，具有更少的歧义性和更高的效率，有助于深入了解编程的近端最佳点。这种新方法减少了初始接触选择时间，简化了流程，并确保为每位患者提供更精确、量身定制的治疗。 ”

"Our dedication to advancing DBS research and innovation has transformed therapeutic options for individuals with movement disorders and epilepsy," said Amaza Reitmeier, vice president and general manager, Neuromodulation portfolio at Medtronic. "With this FDA approval, which quickly followed our CE Mark, we are taking another significant step forward in delivering sensing-enabled personalized treatments to people with Parkinson's."

美敦力公司神经调节产品线副总裁兼总经理Amaza Reitmeier表示：“我们致力于推进 DBS 研究和创新，为患有运动障碍和癫痫的患者带来了全新的治疗选择。继获得 CE 标志后，FDA 迅速批准了这项技术，我们在为帕金森患者提供基于传感的个性化治疗方面又迈出了重要一步。”

BrainSense™ aDBS and EI are also available(opens new window) in Europe. Patient programmings in the United States will begin at select healthcare systems over the coming weeks with availability nationwide in the coming months.

BrainSense™ aDBS 和 EI 也可用（打开新窗口）在欧洲。美国的患者计划将在未来几周内在部分医疗系统中启动，并在未来几个月内在全国范围内推广。

Since 1987, Medtronic has served more than 185,000 people with movement disorders and other indications in more than 70 countries with its life-changing cDBS therapy3. Patients considering DBS therapy should discuss treatment options with their healthcare provider.

自 1987 年以来，美敦力已通过其改变生活的 cDBS 疗法3为 70 多个国家的 185,000 多名患有运动障碍和其他疾病的患者提供服务。考虑接受 DBS 疗法的患者应与其医疗保健提供者讨论治疗方案。