Medtronic's Breakthrough Adaptive Deep Brain Stimulation System Receives FDA and CE Approval for Parkinson’s Disease Treatment

Deep Brain Stimulation (DBS)Can be used for treatmentParkinson's Disease (PD)Some motor complications that cannot be adequately controlled by medication are currently being addressed in a continuous mode, where stimulation settings remain constant and do not adapt to the symptom fluctuations between "On" and "Off" states in Parkinson's patients under drug therapy.

With technological advancements, personalized DBS is gradually emerging, including providing stimulation to targeted areas through directional leads, and viaAdaptive DBS (aDBS)The algorithm triggers stimulation when needed, in an adaptive manner.Providing the appropriate level of stimulation or "dose" when needed could offer patients a more stable method of symptom control.As the disease progresses, with increasing motor complications and symptom fluctuations, this need is particularly urgent in the continuous care system for Parkinson's disease. Currently, the most promising control signal for aDBS is the local field potential (LFP) beta-band oscillation power in the internal segment of the globus pallidus or the subthalamic nucleus, which correlates with symptom fluctuations in Parkinson’s disease and responds to medication and DBS treatment. (Recommended reading:[Everyone Says] Professor Zhang Jianguo Guides You Through "An Innovative Research Achievement on Closed-Loop Adaptive Deep Brain Stimulation for the Treatment of Parkinson's Disease"）

On February 24, 2025, the global leader in healthcare technologyMedtronicAnnounced that its subsidiaryBrainSense Adaptive DBS Technology and Electrode Identifier, following the CE certification in Europe in January 2025, it has also received approval from the U.S. Food and Drug Administration (FDA). AsThe World's First Adaptive Brain Pacemaker with Closed-Loop Functionality, this heavyweight technology has been approved by the FDA again, marking a milestone breakthrough in the application of closed-loop stimulation technology, and ushering in a new era of individualized treatment with brain pacemakers.

It is reported that the aDBS technology, exclusively launched by Medtronic, is equipped in its subsidiary.Percept PC Neurostimulator, which can automatically adjust stimulation parameters based on real-time changes in the patient's intracerebral LFP signals, aiming to achieve personalized treatment for Parkinson’s disease, automatic disease control, and extended battery life.

Scan the QR code to read the recommendation: "[Trendsetter] Percept RC Neurostimulator with Medtronic's Exclusive BrainSense Technology Receives FDA Approval"

In fact, as early as December 2020, Medtronic had launchedInternational Multicenter, Prospective, Single-Blind, Randomized Crossover Study (NCT04547712)——“The ADAPT-PD Trial: An aDBS Algorithm for Personalized Treatment of Parkinson's Disease””, aiming to verify the safety and efficacy of aDBS in treating Parkinson's disease. It is reported that this study is currently the largest and longest aDBS evaluation being conducted simultaneously in clinical and home environments, with a planned completion date of October 2025. It is expected to further validate the clinical potential of BrainSense aDBS technology. (Recommended reading:Medtronic's Pioneering ADAPT-PD Clinical Trial Method Officially Published, Setting New Standards for Parkinson's Disease Research）

ADAPT-PD Global Principal Investigator, Dr. Helen Bronte-Stewart, Professor of Neurology and Neuroscience at Stanford UniversityIndicates:“aDBS will help revolutionize the treatment of Parkinson's disease.This transformative personalized care, achieved through automatic adjustments, allows treatment to adapt to patients' changing needs in a highly beneficial way."

Paolo Di Vincenzo, President of the Neuromodulation Business in Medtronic's Neuroscience PortfolioIndicates:"Our BrainSense technology provides unique and clinically valuable insights.It provides a real-time, long-term window into the patient's condition by leveraging their own brain signals.We are always committed to developing solutions that fit real life, rather than being limited to isolated symptom management. aDBS is the tangible embodiment of this commitment.Brings New Hope for Parkinson's Disease Treatment。”

It is worth mentioning that the approval was granted simultaneously to Medtronic'sBrainSense Electrode IdentifierIt can shorten the time for setting patients' DBS programs in clinics, with a speed increase of 85% compared to traditional electrode selection, assisting clinicians in precise and efficient initial program setup.

In response to this,Drew Kern, Ph.D., Associate Professor of Neurology at the University of Colorado School of MedicineIndicates:"Compared with traditional electrode selection methods, the BrainSense electrode identifier improves operational accuracy and efficiency by providing personalized real-time brief data of patients' brain signals. This helps to gain deeper insights into the proximal optimal stimulation area for program settings, shorten the time for initial electrode contact selection, streamline the operation process, and ensure more precise personalized treatment for each patient."