FDA approves first adaptive deep brain stimulation system for Parkinson’s

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Medtronic plc, a leading global health care technology company based in Galway, Ireland, has received U.S. Food and Drug Administration (FDA) approval for BrainSense Adaptive deep brain stimulation (aDBS) — the first system of its kind to dynamically adjust therapy based on individual brain activity. The approval is a significant development in the treatment of Parkinson’s disease, which affects approximately one million Americans.

Deep brain stimulation (DBS) has been a cornerstone of treatment for over 30 years, using a surgically implanted neurostimulator to transmit electrical signals to targeted brain regions affected by Parkinson’s and other neurological disorders.

Medtronic’s latest advancement enhances its “Percept DBS” neurostimulators with BrainSense Adaptive technology, enabling real-time, personalized therapy in clinical settings and daily life.

“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 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.”

The FDA approval also includes the BrainSense Electrode Identifier (EI), a tool designed to streamline and enhance DBS programming by providing clinicians with precise real-time data.

Medtronic states that EI reduces the time required for initial programming by 85% compared to traditional methods for electrode selection.

“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,” said Drew Kern, MD, MS, a neurologist and associate professor of neurology at the University of Colorado School of Medicine.

“This new method reduces initial contact selection time, streamlining the process and ensuring more precise, tailored therapy for each patient.”

The Medtronic Adaptive DBS Algorithm for Personalized Therapy in Parkinson’s Disease (ADAPT-PD) trial — the largest and longest assessment of aDBS to date — evaluated the safety and effectiveness of the technology.

Helen Bronte-Stewart, MD, MSE, FAAN, FANA, John E. Cahill Family Professor in the department of Neurology at Stanford University School of Medicine, emphasized the potential impact of the new system. “Adaptive deep brain stimulation will help revolutionize the approach to therapeutic treatment for patients with Parkinson’s disease. The transformative personalized care we can achieve through automatic adjustment greatly benefits patients receiving therapy that adapts to their evolving needs.”

The aDBS technology aims to improve symptom control for patients who experience motor fluctuations and dyskinesias with conventional DBS (cDBS).

“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 and investigator for the ADAPT-PD trial.

The system’s launch marks the most extensive commercial rollout of brain-computer interface (BCI) technology to date. Medtronic sees BCI as a key component in advancing Parkinson’s therapies, with a focus on improved rehabilitation and restoring health through personalized neuromodulation.

With BrainSense aDBS and EI already available in Europe, U.S. patient programming will begin in select health care systems in the coming weeks, with nationwide availability expected in the coming months.