Medtronic’s Percept PC neurostimulator with BrainSense technology [Image courtesy of Medtronic]

美敦力的Percept PC神经刺激器搭载BrainSense技术 [图片由美敦力提供]

Medtronic

美敦力

(NYSE: MDT)

（纽约证券交易所代码：MDT）

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announced today that the FDA approved its BrainSense adaptive deep brain stimulation (aDBS) platform.

今天宣布，FDA批准了其BrainSense自适应深部脑刺激（aDBS）平台。

The company also received approval for its BrainSense Electrode Identifier (EI). Together, these technologies use a minimally invasive, surgically implanted neurostimulator to transmit electrical signals to specific parts of the brain affected by neurological disorders. They act as a sort of brain pacemaker to treat Parkinson’s disease..

该公司还获得了其 BrainSense 电极识别器 (EI) 的批准。这些技术共同使用一种微创的、外科植入的神经刺激器，将电信号传输到受神经系统疾病影响的大脑特定部位。它们充当一种大脑起搏器来治疗帕金森病。

BrainSense aDBS, delivered through the Medtronic Percept neurostimulator, provides real-time, adaptive therapy. It dynamically adjusts stimulation based on each person’s unique brain activity, both in clinical settings and daily life. The BrainSense EI technology can improve DBS programming by ensuring optimal initial contact selection in less time..

通过美敦力Percept神经刺激器提供的BrainSense aDBS，提供实时的自适应治疗。它可以根据每个人的独特脑活动动态调整刺激，无论是在临床环境还是日常生活中。BrainSense EI技术能够通过确保在更短时间内选择最佳初始接触点来优化DBS编程。

Percept with BrainSense technology records and analyzes brain signals to enable tailored therapy for each patient’s unique neurological patterns. Medtronic also has work underway on incorporating brain-computer interface (BCI) technolgoy into its DBS therapy. It aims to make advances in prevention, detection, diagnosis, rehabilitation and restoration for patients with complex neurological conditions..

Percept采用BrainSense技术记录和分析大脑信号，为每位患者独特的神经模式提供定制治疗。美敦力还在进行将脑机接口（BCI）技术融入其DBS治疗的工作。其目标是在预防、检测、诊断、康复和恢复方面取得进展，以帮助患有复杂神经系统疾病的患者。

In addition to the FDA nod, Medtronic began its European rollout for the system

除了获得FDA的批准，美敦力还开始了该系统在欧洲的推广。

after winning CE mark last month

上个月获得CE标志后

. The medtech giant plans to begin patient programmings in the U.S. at select healthcare systems over the coming weeks. It plans for availability nationwide in the coming months.

医疗器械巨头计划在未来几周内在美国的部分医疗系统开始患者编程。它计划在未来几个月内在全国范围内提供服务。

“Medtronic is the only company in the world to offer an adaptive DBS system that dynamically adjusts therapy in real time. 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,” said Brett Wall, EVP and president of Medtronic Neuroscience..

“美敦力是全球唯一一家提供自适应DBS系统的企业，该系统能够实时动态调整治疗方案。这一帕金森病治疗的新时代代表了十多年的专注创新——开启了大规模个性化神经调节的时代，能够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，并为DBS治疗设定了新的标准。”美敦力神经科学业务执行副总裁兼总裁布雷特·沃尔表示。

More about the Medtronic BrainSense aDBS technology

有关美敦力BrainSense aDBS技术的更多信息

Medtronic continues to further highlight the potential of aDBS in clinical practice in the ADAPT-PD trial.

美敦力在ADAPT-PD试验中继续进一步凸显aDBS在临床实践中的潜力。

It unveiled this novel approach to Parkinson’s in September 2024

它在2024年9月揭示了这种治疗帕金森病的新方法。

. The study looks at the safety and effectiveness of chronic dual and single threshold aDBS models as compared to continuous DBS across all Parkinson’s patients eligible for DBS.

该研究比较了慢性双阈值和单阈值aDBS模型与连续DBS在所有符合条件的帕金森病患者中的安全性和有效性。

Medtronic said the study remains ongoing as the largest, longest assessment of aDBS in an at-home setting. Investigators monitored participants over four phases spanning more than a year. That included baseline examination, initial aDBS setup and adjustment, evaluation and long-term follow-up. Medtronic then offered all participants extended access to aDBS therapy after the follow-up period..

美敦力表示，这项研究仍在进行中，是对家庭环境中aDBS的最大规模、最长周期的评估。研究人员对参与者进行了四个阶段的监测，历时超过一年。这包括基线检查、初始aDBS设置和调整、评估以及长期随访。随后，美敦力在随访期结束后为所有参与者提供了延长使用aDBS疗法的机会。

Preliminary data indicates a high brain signal presence both on and off medications, in both DBS target locations and patients of all PD phenotypes.

初步数据显示，在用药和未用药的情况下，所有帕金森病表型的患者在脑深部刺激靶点位置均显示出高度的脑信号存在。

“Our dedication to advancing DBS research and innovation has transformed therapeutic options for individuals with movement disorders and epilepsy,” said

“我们致力于推进DBS研究和创新，这已经为运动障碍和癫痫患者转变了治疗选择，”

Amaza Reitmeier

阿玛扎·雷特迈尔

, VP and GM, Medtronic Neuromodulation. “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.”

，美敦力神经调节部门副总裁兼总经理。“随着这项FDA批准，紧随我们获得CE标志之后，我们在为帕金森病患者提供基于感知的个性化治疗方面又迈出了重要的一步。”

Medtronic said the development of its complete, sensing enabled DBS system puts it “at the forefront of incorporating BCI technology into DBS therapy.” The company says it considers BCI technology a crucial element for developing treatments for Parkinson’s.

美敦力表示，其完整、支持感知功能的DBS系统开发使其“处于将BCI技术融入DBS治疗的前沿。”该公司表示，它认为BCI技术是开发帕金森病治疗方法的关键要素。

“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

“我们的BrainSense技术提供了独特且在临床上非常重要的见解，这是其他任何DBS系统都无法提供的。它利用一个人自己的脑信号，实时地、持续地为他们的病情提供了一个窗口。”

Paolo Di Vincenzo

保罗·迪·文森佐

, president of Medtronic Neuromodulation. “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.”

美敦力神经调节业务总裁表示：“我们的重点一直是创造适用于真实生活的解决方案，而不仅仅是孤立的症状。aDBS反映了这一承诺，为帕金森病的治疗带来了新的期望。”