Medtronic receives CE mark for adaptive brain stimulation system
Medtronic has secured CE mark approval for its BrainSense Adaptive deep brain stimulation (aDBS) system and BrainSense Electrode Identifier, introducing the first closed-loop DBS technology with real-time adjustment capabilities. The system, which responds to individual brain signals, represents a major development in personalised treatment for Parkinson’s disease.
The BrainSense aDBS system builds upon Medtronic’s established Percept DBS platform, incorporating brain-computer interface (BCI) technology to enable dynamic stimulation adjustments based on real-time brain signal monitoring. This advancement marks a departure from traditional continuous deep brain stimulation (cDBS), allowing for personalised therapeutic responses aligned with individual neurological patterns.
Clinical implementation and validation
The first European programming was performed by Dr Martijn Beudel at Amsterdam University Medical Center, demonstrating the system’s practical application. The technology’s efficacy is being evaluated through the Adaptive DBS Algorithm for Personalized Therapy in Parkinson’s Disease (ADAPT-PD) trial, a global, multi-centre study comparing dual- and single-threshold aDBS modes with conventional cDBS.
Enhanced programming efficiency
The BrainSense Electrode Identifier introduces a novel approach to contact selection, utilising local field potentials (LFP) and alpha-beta activity measurements to optimise electrode placement. This technology significantly reduces programming time compared to standard monopolar reviews, potentially streamlining the clinical workflow.
European market implications
With Parkinson’s disease affecting over 1.2 million patients in Europe, the CE mark approval represents a significant development in treatment options. The system is scheduled for European market release in early 2025, whilst FDA approval remains pending in the United States.
Professor Alan Whone, PhD, from the University of Bristol and North Bristol NHS Trust, commented: “The CE Mark approval of BrainSense Adaptive DBS is a critical advancement in how we treat Parkinson’s disease. Its potential to address certain challenging motor symptoms and improve day-to-day disease management offers new hope for patients and their families.”
The technology builds upon Medtronic’s extensive experience in DBS therapy, which has treated more than 185,000 patients globally since 1987. This latest innovation represents a significant step forward in the company’s commitment to advancing personalised neuromodulation therapies.
- For more information, visit: https://www.medtronic.com/uk-en/patients/treatments-therapies/deep-brain-stimulation-parkinsons-disease.html
