Medtronic has received U.S. Food and Drug Administration approval for its BrainSense Adaptive deep brain stimulation system, a closed-loop neuromodulation therapy designed to treat patients with Parkinson’s disease.
Integrated into the Percept Deep Brain Stimulation neurostimulator, the novel system uses a closed-loop approach that automatically adjusts stimulation parameters in real time based on individual brain activity, reducing the need for patient-initiated adjustments, according to a press release from Medtronic.
Deep brain stimulation (DBS) has been an established treatment for Parkinson’s disease and other movement disorders for over 30 years, functioning similarly to a cardiac pacemaker by delivering targeted electrical impulses to specific brain regions through a surgically implanted neurostimulator. The novel system builds upon this foundation by incorporating brain-computer interface technology that enables continuous monitoring and adjustment of stimulation in response to fluctuations in neural activity. According to Medtronic, the system builds on more than a decade of research focused on brain-computer interface technology.
The approval follows the Adaptive DBS Algorithm for Personalized Therapy in Parkinson’s Disease trial, a multicenter, international, prospective, single-blind, randomized crossover study in which researchers evaluated the safety and efficacy of dual- and single-threshold adaptive DBS compared with continuous DBS. The study was conducted in clinical and home settings and assessed adaptive DBS in patients with Parkinson’s disease receiving DBS therapy.
The FDA has also approved the BrainSense Electrode Identifier, designed to assist physicians in identifying electrode contacts using real-time brain signal data. According to Medtronic, the tool has been shown to reduce electrode selection time by up to 85% compared with traditional methods.
The approval represented one of the largest commercial deployments of brain-computer interface technology to date. Patient programming is expected to begin in select U.S. health care systems in the coming weeks, with broader availability anticipated in the following months.
