Medtronic has received CE marks under the European Union’s Medical Device Regulation (EU MDR) for the BrainSense adaptive deep brain stimulation (aDBS) system and electrode identifier (EI) for Parkinson’s disease therapy.
aDBS transmits electrical signals to the brain to disrupt certain unwanted movements for patients living with Parkinson’s disease. With the technology, patients receive real-time therapy that automatically adjusts stimulation based on their unique brain activity. This differs from DBS technology, a Parkinson’s therapy modality that has been available for around 30 years and delivers constant electrical pulses.
Commenting on a pair of studies in aDBS that are currently underway at the University of California, San Francisco (UCSF), GlobalData medical device analyst Cynthia Stinchcombe said the technology held the potential to “transform” the Parkinson’s disease treatment landscape.
Medtronic’s neuromodulation president Paolo di Vicenzo commented: "BrainSense technology is at the centre of personalising DBS therapy, and we are advancing this capability through innovation that builds on our sensing-enabled DBS platform.
"From improved precision for contact selection to automatically adjusting DBS therapy, these milestones mark significant advancements in our ability to customise care for people with Parkinson's, and we're just getting started.”
The medtech giant has also received a CE mark for BrainSense EI, which provides a detailed view of the brain signals of Parkinson's patients to help clinicians improve DBS programming and therapy optimisation.
Domenico de Paolis, vice president of Neuromodulation International at Medtronic, explained: “BrainSense EI allows clinicians to now conduct accurate and precise initial programming, offering a level of personalisation unmatched in the field.
"Clinicians will appreciate less ambiguity and greater efficiency compared to the traditional method of electrode selection.
The first programming of BrainSense – asserted by Medtronic as being a first within Europe – on a Parkinson’s disease patient was recently performed by Dr Martijn Beudel, neurologist and associate professor in the Department of Neurology at Amsterdam University Medical Center.
Medtronic now expects BrainSense aDBS and BrainSense EI to be available in Europe in early 2025.
The global neurological devices market was valued at $12.5bn in 2023 and is forecast to reach $20.9 billion by 2033, as per a report by GlobalData.
Research indicates that around 1.2 million people are living with Parkinson’s in Europe while the World Health Organization (WHO) estimates a global disease prevalence of around 8.5 million.
Last year, German-headquartered biotech Centogene published a paper on initial data from its Rostock International Parkinson’s Disease (ROPAD) genetic profiling study. As of 2024, the study has been running for almost five years, with the goal being to characterise the genetics of Parkinson’s to establish a better understanding of the disease progression, diagnosis, and treatment.
Based on the initial data, Centogene’s chief genomic officer Peter Bauer concluded that the implementation of genetic testing for Parkinson’s should become a standard of care.
