Medtronic achieves CE Mark approval for BrainSense™ Adaptive deep brain stimulation and Electrode Identifier, an advance in personalized care for people with Parkinson's

Medtronic achieves CE Mark approval for BrainSense™ Adaptive deep brain stimulation and Electrode Identifier, an advance in personalized care for people with Parkinson's

January 15, 2025

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Medtronic’s BrainSense adaptive deep brain stimulation (aDBS) system and Electrode Identifier have received CE Mark approval in the European Union and U.K., signifying they meet stringent safety, health, and environmental standards for treating Parkinson’s disease. The aDBS system represents a significant advancement over conventional DBS by automatically adjusting stimulation levels in real-time based on brain activity, offering a highly personalized approach to symptom management. The system also features the BrainSense Electrode Identifier, which enhances DBS programming by providing detailed views of brain signals, enabling more precise electrode placement and reducing the time required for initial programming. This innovation helps clinicians deliver stimulation tailored to a patient’s unique neurological activity, improving treatment outcomes. Medtronic’s Percept PC DBS neurostimulator with BrainSense technology records and analyzes brain signals even during therapy, offering valuable insights both inside and outside the clinic. These advancements aim to optimize care for Parkinson’s patients, particularly those with advanced disease where medications no longer provide adequate symptom control. The system’s safety and effectiveness are being evaluated in the ADAPT-PD clinical trial, which has shown that nearly all patients exhibit strong symptom-related brain signals necessary for aDBS, regardless of disease severity or electrode placement. Medtronic has also applied for FDA approval, aiming to make the technology available in the U.S. while it becomes accessible in Europe this year.

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