The first-of-its-kind Medtronic Percept deep brain stimulation (DBS) system is poised to take another big step for neurostimulation technology.

When it won FDA approval in 2020, Percept PC was the first and only DBS system that could chronically capture and record brain signals while delivering therapy for neurologic disorders associated with Parkinson’s disease, essential tremor, dystonia, epilepsy or obsessive-compulsive disorder.

The FDA approved the Percept RC rechargeable version in January 2024. In August 2024, the Percept platform won another first-of-its-kind FDA approval for implantation of the system — leads in the brain run under the scalp, down the neck and to the stimulator implant in the chest or abdomen — while the patient is asleep. Previously, patients needed to remain conscious during the surgery, but the Medtronic Neuromodulation business presented the FDA with data showing the procedure was safe when conducted on patients under general anesthesia.

Most recently, Medtronic Neuromodulation won expanded magnetic resonance imaging (MRI) labeling from the FDA after demonstrating the safety of longer scans for patients with these DBS systems— and for the neurostimulators to remain active, helping  patients remain still during the imaging procedure.

Adaptive deep brain stimulation

Now another big advance — adaptive DBS — is coming soon, Medtronic VP and Brain Modulation GM Amaza Reitmeier said in an interview with Medical Design & Outsourcing.

“We’ve publicly announced that we’ve completed enrollment in the first-of-its-kind study of chronic use of adaptive DBS,” she said. “It’s a study called Adapt-PD, and that was the first time that adaptive DBS was studied outside of the lab. Prior to that study being run, it had only been tested in the lab for up to eight hours at a time.”

“We tested two different modes of adaptive stimulation in a chronic study over the period of a year and we’ll be publishing the results of that study at an upcoming medical meeting,” she continued. “The results of that study, however, are under review by FDA right now, and we’re anticipating FDA to approve using adaptive DBS for Medtronic patients with the Percept device sometime within the next few months.”

Adaptive DBS allows the system to automatically adjust neurostimulation levels up or down according to brain signals — specifically, the beta signal — that the system’s directional SenSight leads can sense.

Approved by the FDA in 2022, Medtronic’s SenSight leads were the first to market for both delivering DBS therapy and sensing brain signals. The leads have four platinum iridium electrodes for stimulation and sensing.

“The beta signal fluctuates with the symptoms of Parkinson’s. When the beta signal is high, the symptoms of Parkinson’s tend to be high,” Reitmeier said. “If our stimulation can suppress the beta signal, the symptoms tend to go away. So we know that there is a direct correlation between presence and absence of beta and presence or absence of symptoms.”

Percept patients and their doctors can already see the beta signal readings and adjust therapy accordingly, but adaptive DBS would make those adjustments automatically, a technology also referred to as closed-loop stimulation.

“We’ll be launching gen one in the foreseeable future,” Reitmeier said. “But this just the start, because as we continue to learn more about the brain and how the signals are useful in either predicting or giving us feedback on how well the therapy is working, we think that there’s a lot more room here to make DBS therapy work better for patients.”

Future advances in adaptive DBS

Reitmeier pointed to a recent adaptive DBS study at University of California San Francisco that used a research version of Medtronic’s neurostimulation devices. Researchers developed an adaptive DBS system that can prevent Parkinson’s symptoms before they occur, reducing the most bothersome movement symptoms by an average of 50%, according to results published in Nature Medicine.

Medtronic plans to test the different kinds of adaptive algorithms from those researchers to build the adaptive DBS technology beyond this upcoming first generation.

“We’ve got 40,000 implanted patients around the world,” she said. “When we learn something that’s useful to them, we can apply those upgrades through a software update to the device. Those are wonderfully upgradable platforms for patients. So as we continue to learn, they’ll continue to benefit.”