
Medtronic today announced CE Mark approval in the European Union (EU) and the United Kingdom (UK) for BrainSense Adaptive deep brain stimulation (aDBS) and BrainSense Electrode Identifier (EI), having achieved the standards required by the EU Medical Device Regulation (MDR).
With BrainSense aDBS, people with Parkinson's disease can receive real-time, adaptive therapy that dynamically adjusts stimulation based on each person's brain activity. The Medtronic Percept DBS system with BrainSense technology is designed to record and analyze brain signals, enabling therapies tailored to each patient's unique neurological patterns.
"Medtronic remains the first and only company in the world to offer a complete sensing-enabled DBS system, and now we have enhanced this innovation to allow patients with Parkinson's to spend less time thinking about their disease," said Amaza Reitmeier, vice president and general manager, Neuromodulation marketing and strategy at Medtronic. "Patients and clinicians have been eagerly awaiting these BrainSense technology enhancements, which represent another transformative step forward in our ability to personalize therapy for people living with Parkinson's."
The Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) trial further highlights the potential of aDBS in clinical practice. Conducted as a global, multi-center, prospective, single-blind randomized crossover study (between two modes of aDBS), the trial evaluates the safety and effectiveness of chronic dual- and single-threshold aDBS modes compared to cDBS for eligible Parkinson's patients receiving DBS therapy. Developed in collaboration with more than a dozen world-renowned neurologists and neurosurgeons from leading academic institutions across the globe, this study represents the largest and longest assessment of aDBS conducted in both clinical and home settings.
BrainSense aDBS and BrainSense Electrode identifier will be available in Europe in early 2025. Patients considering DBS therapy should discuss treatment options with their provider. Medtronic has filed for U.S. FDA approval of aDBS; it is not yet approved for sale or distribution in the United States.