Medtronic achieves CE Mark approval for BrainSense Adaptive deep brain stimulation
Summary
Medtronic announced CE Mark approval in the EU and UK for BrainSense Adaptive DBS and BrainSense Electrode Identifier, achieving EU Medical Device Regulation standards. The system is the world's only closed-loop DBS with real-time, self-adjusting brain stimulation for Parkinson's disease. The first programming was completed at Amsterdam University Medical Center.
Why it matters
Adaptive DBS that responds to real-time brain activity represents a significant advance over conventional constant-stimulation DBS. The CE Mark under MDR demonstrates that the system meets Europe's stringent new medical device standards, potentially improving outcomes for over 1.2 million European Parkinson's patients.
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