Medtronic announced FDA approval for its BrainSense adaptive deep brain stimulation (aDBS) platform, along with its BrainSense Electrode Identifier (EI). These technologies use a minimally invasive, surgically implanted neurostimulator to transmit electrical signals to targeted brain regions affected by neurological disorders, acting as a brain pacemaker to treat Parkinson’s disease.
BrainSense aDBS, delivered through the Medtronic Percept neurostimulator, provides real-time, adaptive therapy by dynamically adjusting stimulation based on each patient’s unique brain activity in both clinical settings and daily life. The BrainSense EI technology enhances DBS programming by optimizing initial contact selection more efficiently. Percept with BrainSense technology records and analyzes brain signals, enabling personalized therapy tailored to each patient’s neurological patterns. Medtronic integrates brain-computer interface (BCI) technology into its DBS therapy to advance prevention, detection, diagnosis, rehabilitation, and restoration for complex neurological conditions.
Following FDA approval, Medtronic has begun rolling out the system in Europe after securing CE Mark last month. In the U.S., patient programming at select healthcare systems will begin in the coming weeks, with nationwide availability expected soon.
“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.
Medtronic continues to explore the potential of aDBS in clinical practice through the ADAPT-PD trial, which launched in September 2024. The study evaluates the safety and effectiveness of chronic dual and single threshold aDBS models compared to continuous DBS across all Parkinson’s patients eligible for DBS. As the largest and longest assessment of aDBS in an at-home setting, the trial spans four phases over more than a year, including baseline examination, aDBS setup and adjustment, evaluation, and long-term follow-up. Participants were later offered extended access to aDBS therapy. Preliminary data suggests a high brain signal presence both on and off medications across all DBS target locations and Parkinson’s disease phenotypes.
Medtronic’s fully sensing-enabled DBS system positions it at the forefront of incorporating BCI technology into DBS therapy, which the company views as essential for future Parkinson’s treatments.
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