FDA approves first adaptive deep brain stimulation system for Parkinson’s disease
Key takeaways:
- The adaptive deep brain stimulation technology is the first of its kind to address symptoms of Parkinson’s disease.
- The new technology is expected to be available in the US later in 2025.
The FDA has approved BrainSense, an adaptive deep brain stimulation system that can adjust therapy for Parkinson’s disease in real time based on the patient’s brain activity, according to the manufacturer.
In a press release, Ireland-based health care technology firm Medtronic said the approval was based on results from the ADAPT-PD clinical trial, an international, multicenter, prospective, single-blind, randomized crossover study that included 68 individuals with PD who were already receiving DBS therapy.
Participants were fitted with either subthalamic nucleus or globus pallidus internus DBS leads connected to a Medtronic Percept PC neurostimulator.
The study, which compared chronic dual- and single-threshold adaptive DBS modes vs. continuous DBS, supported the safety and effectiveness of the novel system, the company said.
The approval also includes the BrainSense Electrode Identifier (EI), which assists in reducing patient visit times to the clinic for individualized DBS programming. The EI allows for “accurate and precise initial programming” up to 85% faster than traditional electrode selection methods, according to the release.
“The FDA approval of Medtronic BrainSense Adaptive deep brain stimulation and Electrode Identifier is a major step forward in how we personalize sensing-enabled deep brain stimulation,” Paolo Di Vincenzo, president of the neuromodulation business at Medtronic, told Healio. “For the first time, DBS can automatically adjust in real time based on a patient’s unique brain activity.”
Adaptive DBS is available for Medtronic DBS patients with PD who have the Percept neurostimulator implant, “as well as future Medtronic DBS patients,” the company said.
Medtronic said that United States-based patient programming is expected to begin at selected health care systems this year, with nationwide availability expected in the next several months.
The FDA approved Medtronic’s Asleep Deep Brain Stimulation surgery for PD in August 2024.
Reference:
Bronte Stewart H, et al. NPJ Parkinsons Dis. 2024;doi:10.1038/s41531-024-00772-5.