Shortly after obtaining a greenlight in Europe and after more than 10 years in development, Medtronic has now received the FDA’s approval for its adaptive, closed-loop neurostimulation approach to treating the motor symptoms that come with Parkinson’s disease.
The company said its U.S. rollout represents the largest-ever commercial launch of a brain-computer interface technology, with Medtronic’s BrainSense platform reading changes in a patient’s neural activity in real-time and then adjusting therapy to suit.
While deep-brain stimulation has been available to patients for decades—through implants that send electric signals similar to how pacemakers connect with the heart—adaptive stimulation aims to personalize therapies during daily life.
In a real-world clinical study published last year, data showed that by reading activity in the areas of the brain linked with Parkinson’s, including the globus pallidus internus and subthalamic nucleus, the device could detect a user’s “on” or “off” phases—with motor and non-motor symptoms being the strongest during off periods, which typically come in-between medication doses.
By targeting neurostimulation to the off phase, the study’s initial findings showed the implant could help reduce the need for medication while also minimizing the side effects that can occur when deep-brain therapy and peak drug levels overlap. Dubbed ADAPT-PD, the trial’s full results are expected in the future.
“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,” Paolo Di Vincenzo, president of Medtronic’s neuromodulation business, said in a statement.
“Our focus has always been on creating solutions that work for real lives, not just standalone symptoms,” Di Vincenzo added. “aDBS reflects that commitment, bringing a new expectation in Parkinson's treatment.”
BrainSense will be available through the company’s Percept neurostimulator implants. Medtronic previously set the stage for the technology with an FDA approval in 2021 for deep-brain stimulation hardware that could sense and record changes in local electric field potentials.
Now the adaptive program can be programmed into already implanted devices wirelessly, essentially as a software update. Alongside the announcement of a CE mark approval in January, the company said the first patient began receiving the feature the same day. Medtronic said more than 40,000 patients worldwide with Percept devices may be eligible for the therapy.
And like in Europe, the FDA’s green light also includes the BrainSense Electrode Identifier, which Medtronic said can help reduce the amount of time patients need to spend in the clinic to calibrate their deep-brain stimulation settings by displaying their personal neural activity.
Medtronic said patient programming in the U.S. will begin at select healthcare systems in the next few weeks, with nationwide availability in the coming months.