Medtronic's BrainSense Adaptive DBS Receives CE Mark for Personalized Parkinson's Therapy
Key Insights
Medtronic's BrainSense Adaptive Deep Brain Stimulation (search) (aDBS) and Electrode Identifier (EI) have received CE Mark approval in the EU and UK.
The aDBS system offers real-time, self-adjusting brain stimulation for Parkinson's disease (search), adapting to individual patient's unique brain activity.
BrainSense Electrode Identifier improves DBS programming by facilitating optimal initial contact selection, reducing programming time for clinicians.
Medtronic has secured CE Mark approval in the European Union and the United Kingdom for its BrainSense Adaptive Deep Brain Stimulation (search) (aDBS) system and BrainSense Electrode Identifier (EI). This approval marks a significant step forward in personalized, sensing-enabled care for individuals with Parkinson's disease (search).
The BrainSense aDBS system is designed to provide real-time, adaptive therapy by dynamically adjusting stimulation based on a patient's unique brain activity. This closed-loop system aims to optimize treatment by responding to the individual's neurological patterns, both in clinical settings and during daily life. The BrainSense Electrode Identifier enhances the precision and efficiency of DBS programming by guiding clinicians to the optimal contact location, leveraging local field potentials (LFP) and alpha-beta activity to improve programming compared to standard methods.
Advancing Parkinson's Treatment
Deep brain stimulation (DBS) has been used for three decades to manage Parkinson's symptoms by delivering electrical signals to the brain. Medtronic's BrainSense technology builds upon this foundation by incorporating brain-computer interface (BCI) technology to personalize therapy. The system records and analyzes brain signals, allowing for tailored treatments that address the specific needs of each patient.
"Adaptive deep brain stimulation represents an exciting evolution in how we manage Parkinson's," said Martijn Beudel, MD, PhD, neurologist and associate professor, Department of Neurology, Amsterdam University Medical Center. "By using real-time brain activity to automatically adjust stimulation, this technology enhances the ability to deliver patient-specific stimulation that can be adapted to an individual's unique needs."
Clinical Evidence and Implementation
The Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (search) (ADAPT-PD) trial, a global, multi-center, prospective, single-blind randomized crossover study, supports the potential of aDBS. The study evaluated the safety and effectiveness of chronic dual- and single-threshold aDBS modes compared to continuous DBS (cDBS). The study methodology and sensing data were published in npj Parkinson's Disease.
The BrainSense Electrode Identifier (EI) streamlines the initial programming of DBS systems. It provides a detailed view of brain signals, guiding clinicians to the location of the strongest signal more efficiently than traditional monopolar reviews. This technology uses local field potentials (LFP) and alpha-beta activity to pinpoint the optimal contact location, leading to more effective programming.
Impact and Availability
Parkinson's disease (search) affects over 1.2 million people in Europe and more than 10 million worldwide, impacting mobility, speech, focus, and overall quality of life. The BrainSense aDBS and Electrode Identifier are expected to be available in Europe in early 2025. Medtronic has also filed for U.S. FDA approval of aDBS.
"The CE Mark approval of BrainSense Adaptive DBS is a critical advancement in how we treat Parkinson's disease (search)," said Alan Whone, PhD, professor of movement disorders neurology, University of Bristol and North Bristol NHS Trust. "Its potential to address certain challenging motor symptoms and improve day-to-day disease management offers new hope for patients and their families, broadening the transformative impact of deep brain stimulation."