Medtronic earns U.S. FDA approval for the world's first Adaptive deep brain stimulation system for people with Parkinson's
Medtronic (NYSE:MDT) has received FDA approval for BrainSense™ Adaptive deep brain stimulation (aDBS) and BrainSense™ Electrode Identifier (EI), marking a significant advancement in Parkinson's disease treatment. The system represents the largest commercial launch of brain-computer interface technology to date.
The BrainSense™ Adaptive technology enhances Medtronic's Percept™ DBS neurostimulators by automatically adjusting therapy based on real-time brain activity, both in clinical settings and daily life. This personalized neuromodulation system has already served over 40,000 DBS patients worldwide with Percept™ devices.
The approval includes the BrainSense™ Electrode Identifier, which accelerates DBS programming settings by 85% compared to traditional methods. The technology is also available in Europe, with U.S. patient programming set to begin at select healthcare systems in the coming weeks, followed by nationwide availability in the coming months.
Medtronic (NYSE:MDT) ha ricevuto l'approvazione della FDA per il BrainSense™ Adaptive deep brain stimulation (aDBS) e il BrainSense™ Electrode Identifier (EI), segnando un avanzamento significativo nel trattamento della malattia di Parkinson. Il sistema rappresenta il più grande lancio commerciale della tecnologia interfaccia cervello-computer fino ad oggi.
La tecnologia BrainSense™ Adaptive potenzia i neurostimolatori Percept™ DBS di Medtronic, regolando automaticamente la terapia in base all'attività cerebrale in tempo reale, sia in contesti clinici che nella vita quotidiana. Questo sistema di neuromodulazione personalizzata ha già assistito oltre 40.000 pazienti DBS in tutto il mondo con dispositivi Percept™.
L'approvazione include il BrainSense™ Electrode Identifier, che accelera le impostazioni di programmazione DBS dell'85% rispetto ai metodi tradizionali. La tecnologia è già disponibile in Europa, con la programmazione per i pazienti statunitensi che inizierà in alcuni sistemi sanitari selezionati nelle prossime settimane, seguita dalla disponibilità a livello nazionale nei prossimi mesi.
Medtronic (NYSE:MDT) ha recibido la aprobación de la FDA para el BrainSense™ Adaptive deep brain stimulation (aDBS) y el BrainSense™ Electrode Identifier (EI), marcando un avance significativo en el tratamiento de la enfermedad de Parkinson. El sistema representa el mayor lanzamiento comercial de tecnología de interfaz cerebro-computadora hasta la fecha.
La tecnología BrainSense™ Adaptive mejora los neuroestimuladores Percept™ DBS de Medtronic al ajustar automáticamente la terapia en función de la actividad cerebral en tiempo real, tanto en entornos clínicos como en la vida diaria. Este sistema de neuromodulación personalizada ya ha atendido a más de 40,000 pacientes de DBS en todo el mundo con dispositivos Percept™.
La aprobación incluye el BrainSense™ Electrode Identifier, que acelera la configuración de programación de DBS en un 85% en comparación con los métodos tradicionales. La tecnología también está disponible en Europa, con la programación para pacientes en EE. UU. que comenzará en sistemas de salud seleccionados en las próximas semanas, seguida de la disponibilidad a nivel nacional en los próximos meses.
메드트로닉 (NYSE:MDT)은 뇌 감지™ 적응형 심부 뇌 자극(aDBS) 및 뇌 감지™ 전극 식별기(EI)에 대한 FDA 승인을 받았으며, 이는 파킨슨병 치료에서 중요한 발전을 의미합니다. 이 시스템은 지금까지의 뇌-컴퓨터 인터페이스 기술의 가장 큰 상업적 출시를 나타냅니다.
뇌 감지™ 적응형 기술은 메드트로닉의 Percept™ DBS 신경 자극기를 강화하여 임상 환경과 일상 생활 모두에서 실시간 뇌 활동에 따라 치료를 자동으로 조정합니다. 이 개인화된 신경 조절 시스템은 이미 전 세계에서 40,000명 이상의 DBS 환자에게 Percept™ 장치를 제공하였습니다.
승인에는 BrainSense™ 전극 식별기가 포함되어 있으며, 이는 기존 방법에 비해 DBS 프로그래밍 설정을 85% 가속화합니다. 이 기술은 유럽에서도 이용 가능하며, 미국 환자 프로그래밍은 향후 몇 주 내에 일부 의료 시스템에서 시작될 예정이며, 이후 몇 달 안에 전국적으로 이용 가능해질 것입니다.
Medtronic (NYSE:MDT) a reçu l'approbation de la FDA pour la stimulation cérébrale profonde adaptative BrainSense™ (aDBS) et l'identificateur d'électrode BrainSense™ (EI), marquant une avancée significative dans le traitement de la maladie de Parkinson. Ce système représente le plus grand lancement commercial de la technologie d'interface cerveau-ordinateur à ce jour.
La technologie adaptative BrainSense™ améliore les neurostimulateurs Percept™ DBS de Medtronic en ajustant automatiquement la thérapie en fonction de l'activité cérébrale en temps réel, tant dans les milieux cliniques que dans la vie quotidienne. Ce système de neuromodulation personnalisée a déjà aidé plus de 40 000 patients DBS dans le monde entier avec des dispositifs Percept™.
L'approbation inclut l'identificateur d'électrode BrainSense™, qui accélère les réglages de programmation DBS de 85 % par rapport aux méthodes traditionnelles. La technologie est également disponible en Europe, avec la programmation des patients américains qui devrait commencer dans certains systèmes de santé sélectionnés dans les semaines à venir, suivie d'une disponibilité nationale dans les mois à venir.
Medtronic (NYSE:MDT) hat die FDA-Zulassung für die BrainSense™ Adaptive Deep Brain Stimulation (aDBS) und den BrainSense™ Electrode Identifier (EI) erhalten, was einen bedeutenden Fortschritt in der Behandlung der Parkinson-Krankheit darstellt. Das System stellt den größten kommerziellen Start von Gehirn-Computer-Schnittstellentechnologie bis heute dar.
Die BrainSense™ Adaptive Technologie verbessert die Percept™ DBS Neurostimulatoren von Medtronic, indem sie die Therapie automatisch basierend auf der Echtzeit-Hirnaktivität sowohl in klinischen Umgebungen als auch im täglichen Leben anpasst. Dieses personalisierte Neuromodulationssystem hat bereits über 40.000 DBS-Patienten weltweit mit Percept™-Geräten versorgt.
Die Genehmigung umfasst den BrainSense™ Electrode Identifier, der die DBS-Programmierungseinstellungen im Vergleich zu herkömmlichen Methoden um 85% beschleunigt. Die Technologie ist auch in Europa verfügbar, wobei die Programmierung für US-Patienten in den kommenden Wochen in ausgewählten Gesundheitssystemen beginnen soll, gefolgt von einer landesweiten Verfügbarkeit in den kommenden Monaten.
- First FDA-approved adaptive DBS system for Parkinson's disease
- Technology reduces programming time by 85% compared to traditional methods
- Large existing patient base of 40,000 DBS patients worldwide
- Dual market access with both FDA and CE Mark approvals
- None.
Insights
The FDA approval of BrainSense™ Adaptive DBS system represents a pivotal advancement in Medtronic's neuromodulation portfolio, targeting a $1 million+ patient market in the U.S. alone. This breakthrough positions Medtronic uniquely in the DBS market with three key competitive advantages:
First, the closed-loop system's ability to self-adjust therapy creates a significant technological moat. While competitors offer traditional DBS systems, Medtronic's real-time adaptation capability establishes a new standard of care that will be challenging to replicate given the extensive clinical validation through the ADAPT-PD trial.
Second, the 85% reduction in programming time through the BrainSense™ Electrode Identifier translates to substantial operational efficiencies for healthcare providers. This improvement in clinical workflow efficiency could accelerate adoption rates and strengthen Medtronic's market position.
Third, with an installed base of over 40,000 Percept™ device patients, Medtronic has created a significant upgrade opportunity. The compatibility with existing Percept™ neurostimulators enables a clear pathway for recurring revenue through software updates and potential hardware upgrades.
The broader implications extend beyond immediate revenue potential. This approval establishes Medtronic as the leader in commercial brain-computer interface technology, creating a foundation for future applications across neurological conditions. The extensive clinical validation and support from prestigious institutions like Stanford and Harvard Medical School significantly reduce adoption barriers and strengthen reimbursement prospects.
New closed-loop system self-adjusts DBS therapy to individual brain activity in real time; the largest commercial launch of brain-computer interface technology ever
GALWAY,
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.
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.
"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."
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.
"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."
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, a journal within the prestigious Nature Portfolio.
"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."
"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."
The
"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.
"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."
BrainSense™ aDBS and EI are also available in
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. To learn more about Medtronic DBS with BrainSense™ technology, visit our website.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway,
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.
†The sensing feature of the Percept™ PC and Percept™ RC system is intended for use in patients receiving DBS where chronically recorded bioelectric data may provide useful, objective information regarding patient clinical status.
References
- Parkinson's Foundation. (2025). Statistics: Get informed about Parkinson's disease with these key numbers. Retrieved from https://www.parkinson.org.
- Stanslaski S, Summers RLS, Tonder L, et al. Sensing data and methodology from the Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) clinical trial. NPJ Parkinsons Dis. 2024;10(1):174.
- Medtronic data on file.
- Thompson, J., Radcliffe, E., Ojemann, S.,et al. Monopolar sensing improves the efficiency of DBS programming in Parkinson's disease [abstract]. Mov Disord. 2024; 39 (suppl 1). https://www.mdsabstracts.org/abstract/monopolar-sensing-improves-the-efficiency-of-dbs-programming-in-parkinsons-disease/. Accessed 01/29/25
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FAQ
What is the significance of MDT's new FDA approval for BrainSense™ Adaptive DBS?
How many patients currently use Medtronic's Percept™ DBS devices globally?
What improvement does BrainSense™ Electrode Identifier offer for MDT's DBS programming?
When will MDT's BrainSense™ aDBS be available across the United States?
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