Medtronic plc (NYSE:MDT), a global leader in healthcare technology, announced today CE (Conformité Européenne) Mark approval in the European Union (EU) and the United Kingdom (UK) for BrainSense™ Adaptive deep brain stimulation (aDBS) and BrainSense™ Electrode Identifier (EI), having achieved the standards required by the EU Medical Device Regulation (MDR). In addition, the first programming was completed today, performed by Martijn Beudel, MD, PhD, neurologist and associate professor, Department of Neurology, Amsterdam University Medical Center. This landmark approval and first-in-Europe patient programming demonstrate significant advancements in personalized DBS therapy for people with Parkinson's in Europe, including the UK.

全球领先的医疗技术公司美敦力公司 (Medtronic plc) (纽约证券交易所代码：MDT) 今天宣布，BrainSense™ 自适应深部脑刺激 (aDBS) 和 BrainSense™ 电极识别器 (EI) 已获得欧盟 (EU) 和英国(UK) 的 CE（欧洲合格认证）标志认证，符合欧盟医疗器械法规 (MDR) 所要求的标准。此外，首次编程已于今日完成，由阿姆斯特丹大学医学中心神经内科神经病学家兼副教授 Martijn Beudel 医学博士、哲学博士执行。这项具有里程碑意义的批准和欧洲首个患者编程表明，包括英国在内的欧洲在帕金森病患者个性化 DBS 治疗方面取得了重大进展。

For 30 years, people with Parkinson's disease have benefitted from deep brain stimulation (DBS), a technology that transmits electric signals to the brain to disrupt certain unwanted movement. With BrainSense™ aDBS, people with Parkinson's disease can now benefit from real-time, adaptive therapy that dynamically adjusts stimulation based on each person's unique brain activity, both in clinical settings and daily life1. BrainSense™ Electrode Identifier can improve DBS programming by ensuring optimal initial contact selection in less time

30 年来，帕金森病患者一直受益于深部脑刺激 (DBS)，这是一种将电信号传输到大脑以干扰某些不想要的运动的技术。借助 BrainSense™ aDBS，帕金森病患者现在可以受益于实时自适应疗法，该疗法根据每个人独特的大脑活动动态调整刺激，无论是在临床环境还是日常生活中1。BrainSense™ 电极识别器可以通过确保在更短的时间内选择最佳初始接触来改进 DBS 编程。

Caregivers and healthcare providers alike intimately understand how disruptive Parkinson's can be on one's daily life. Affecting over 1.2 million patients in Europe alone and more than 10 million people worldwide, Parkinson's is known to impact an individual's mobility, speech, focus, sleep, independence, and overall ability to participate fully in work, family, and social life. From sipping a cup of coffee to holding hands with a loved one, the disease can be debilitating and demoralizing, stripping away what many of us take for granted. For spouses and caregivers, this can be immensely demanding and distressing

护理人员和医疗保健提供者都非常了解帕金森病对日常生活的破坏性。仅在欧洲就有超过 120 万患者，全世界有超过 1000 万人患有帕金森病，已知帕金森病会影响个人的行动能力、言语能力、注意力、睡眠、独立性以及全面参与工作、家庭和社交生活的整体能力。从喝咖啡到与亲人牵手，这种疾病会使人虚弱和沮丧，剥夺我们许多人认为理所当然的东西。对于配偶和护理人员来说，这可能是极其艰难和令人痛苦的。

"BrainSense™ technology† is at the center of personalizing DBS therapy, and we are advancing this capability through innovation that builds on our sensing-enabled DBS platform," said Paolo Di Vincenzo, president of the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. "From improved precision for contact selection to automatically adjusting DBS therapy, these milestones mark significant advancements in our ability to customize care for people with Parkinson's, and we're just getting started. The mission is to impact and improve many more lives with Medtronic DBS therapy."

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： “BrainSense™ 技术† 是实现个性化 DBS 治疗的核心，我们正在通过基于传感 DBS 平台的创新来推进这一能力。从提高接触选择精度到自动调整 DBS 治疗，这些里程碑标志着我们在为帕金森患者提供个性化治疗方面取得了重大进步，而这仅仅是个开始。我们的使命是通过美敦力 DBS 治疗影响和改善更多人的生活。”

The Medtronic Percept™ DBS system with BrainSense™ technology is designed to record and analyze brain signals, enabling therapies tailored to each patient's unique neurological patterns1. Medtronic has been at the forefront of incorporating brain-computer interface (BCI) technology into DBS therapy with the specific purpose of making advances in prevention, detection, diagnosis, rehabilitation, and restoration for patients with complex neurological conditions. As the world leader in DBS therapy, the Medtronic Percept™ neurostimulators with BrainSense™ technology serves as a benchmark for DBS sensing innovation.

采用 BrainSense™ 技术的 Medtronic Percept™ DBS 系统旨在记录和分析脑信号，从而根据每位患者独特的神经模式量身定制治疗方案1。Medtronic 一直走在将脑机接口 (BCI) 技术融入 DBS 治疗的前沿，其具体目的是为患有复杂神经系统疾病的患者在预防、检测、诊断、康复和恢复方面取得进展。作为 DBS 治疗领域的全球领导者，采用 BrainSense™ 技术的 Medtronic Percept™ 神经刺激器是 DBS 传感创新的标杆。

"Adaptive deep brain stimulation represents an exciting evolution in how we manage Parkinson's," said Martijn Beudel, MD, PhD, neurologist and associate professor, Department of Neurology, Amsterdam University Medical Center. "By using real-time brain activity to automatically adjust stimulation, this technology enhances the ability to deliver patient-specific stimulation that can be adapted to an individual's unique needs."

阿姆斯特丹大学医学中心神经病学系神经病学家兼副教授 Martijn Beudel 医学博士表示：“自适应深部脑刺激代表了我们治疗帕金森病的一项令人兴奋的进步。通过利用实时脑活动自动调整刺激，这项技术增强了提供针对患者特定刺激的能力，可根据个人的独特需求进行调整。”

Medtronic is the originator of continuous deep brain stimulation (cDBS), which has been available for decades as a proven therapy for managing certain Parkinson's disease symptoms. BrainSense™ Adaptive DBS (aDBS) takes treatment to the next level, dynamically calibrating stimulation based upon a patient's own brain signals

美敦力是持续深部脑刺激 (cDBS) 的创始人，该技术数十年来一直被证明是治疗某些帕金森病症状的有效疗法。BrainSense™ 自适应深部脑刺激 (aDBS) 将治疗提升到一个新的水平，可根据患者自己的脑信号动态校准刺激。

"Medtronic remains the first and only company in the world to offer a complete sensing-enabled DBS system, and now we have enhanced this innovation to allow patients with Parkinson's to spend less time thinking about their disease," said Amaza Reitmeier, vice president and general manager, Neuromodulation marketing and strategy at Medtronic. "Patients and clinicians have been eagerly awaiting these BrainSense™ technology enhancements, which represent another transformative step forward in our ability to personalize therapy for people living with Parkinson's."

美敦力公司神经调节营销和战略副总裁兼总经理Amaza Reitmeier表示：“美敦力仍然是全球第一家也是唯一一家提供完整传感 DBS 系统的公司，现在我们增强了这一创新，让帕金森病患者可以花更少的时间思考他们的疾病。患者和临床医生一直热切期待这些 BrainSense™ 技术增强功能，这代表我们在为帕金森病患者提供个性化治疗方面又迈出了变革性的一步。”

The Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) trial further highlights the potential of aDBS in clinical practice. Conducted as a global, multi-center, prospective, single-blind randomized crossover study (between two modes of aDBS), the trial evaluates the safety and effectiveness of chronic dual- and single-threshold aDBS modes compared to cDBS for eligible Parkinson's patients receiving DBS therapy. Developed in collaboration with more than a dozen world-renowned neurologists and neurosurgeons from leading academic institutions across the globe, this study represents the largest and longest assessment of aDBS conducted in both clinical and home settings1. The study methodology and sensing data from the Medtronic study were published in npj Parkinson's Disease(opens new window), a journal within the prestigious Nature Portfolio.

帕金森病个性化治疗的自适应 DBS 算法 (ADAPT-PD) 试验进一步凸显了 aDBS 在临床实践中的潜力。作为一项全球性、多中心、前瞻性、单盲随机交叉研究（在两种 aDBS 模式之间进行），该试验评估了对于接受 DBS 治疗的符合条件的帕金森病患者，慢性双阈值和单阈值 aDBS 模式与 cDBS 相比的安全性和有效性。这项研究由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，是临床和家庭环境中进行的最大、最长的 aDBS 评估1。美敦力研究的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。

"The CE Mark approval of BrainSenseTM Adaptive DBS is a critical advancement in how we treat Parkinson's disease," said Alan Whone, PhD, professor of movement disorders neurology, University of Bristol and North Bristol NHS Trust. "Its potential to address certain challenging motor symptoms and improve day-to-day disease management offers new hope for patients and their families, broadening the transformative impact of deep brain stimulation."

布里斯托大学和北布里斯托 NHS 基金会运动障碍神经学教授Alan Whone博士表示： “BrainSense TM Adaptive DBS 获得 CE 标志批准是我们治疗帕金森病的一项重大进步。它能够治疗某些具有挑战性的运动症状并改善日常疾病管理，为患者及其家人带来了新的希望，扩大了深部脑刺激的变革性影响。”

BrainSense™ Electrode Identifier (EI) elevates precision and efficiency to unprecedented levels by providing a detailed view of each Parkinson's patient's unique brain signals and guiding clinicians to the exact location of the strongest signal in a fraction of the time needed for standard monopolar reviews2. This exclusive technology pinpoints the optimal contact location by leveraging local field potentials (LFP) and alpha-beta activity to guide optimized and effective programming compared to the standard of care, the monopolar review

BrainSense™ 电极识别器 (EI) 可详细查看每个帕金森病患者独特的脑信号，并引导临床医生在标准单极检查2所需时间的一小部分内找到最强信号的准确位置，从而将精确度和效率提升到前所未有的水平。与标准护理（单极检查2）相比，这项独家技术利用局部场电位 (LFP) 和 alpha-beta 活动来精确定位最佳接触位置，以指导优化和有效的编程。

"BrainSense™ Electrode Identifier allows clinicians to now conduct an accurate and precise initial programming, offering a level of personalization unmatched in the field," said Domenico De Paolis, vice president of Neuromodulation International at Medtronic. "Clinicians will appreciate less ambiguity and greater efficiency compared to the traditional method of electrode selection. CE Mark approval is just the first step in our effort to bring this new technology to customers around the world."

美敦力公司神经调节国际副总裁Domenico De Paolis表示：“BrainSense™ 电极识别器现在可让临床医生进行准确而精确的初始编程，提供该领域无与伦比的个性化水平。与传统的电极选择方法相比，临床医生将受益于更少的歧义和更高的效率。CE 标志认证只是我们努力将这项新技术带给全球客户的第一步。”

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 DBS therapy

自 1987 年以来，美敦力公司通过其改变生活的 DBS 疗法5为 70 多个国家的 185,000 多名运动障碍和其他疾病患者提供了服务。

BrainSense™ aDBS and BrainSense™ Electrode identifier will be available in Europe in early 2025. Patients considering DBS therapy should discuss treatment options with their provider. Medtronic has filed for U.S. FDA approval of aDBS; it is not yet approved for sale or distribution in the United States.

BrainSense™ aDBS 和 BrainSense™ 电极识别器将于 2025 年初在欧洲上市。考虑 DBS 治疗的患者应与其提供者讨论治疗方案。美敦力已向美国 FDA 申请批准 aDBS；但尚未获准在美国销售或分销。