Medtronic Wins FDA Approval for Adaptive DBS in Parkinson’s

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BrainSense technology offers real-time, personalized therapy

Medtronic has received FDA approval for its BrainSense adaptive deep brain stimulation (aDBS) platform, marking a major milestone in neuromodulation therapy for Parkinson’s disease. The approval also includes the BrainSense Electrode Identifier (EI), designed to optimize DBS programming.

How BrainSense aDBS Works

  • Uses real-time brain activity to dynamically adjust stimulation.
  • Delivered through the Medtronic Percept neurostimulator for personalized therapy.
  • Incorporates brain-computer interface (BCI) technology for advanced neuromodulation.

With this approval, Medtronic becomes the first company to offer an adaptive DBS system that responds to a patient’s changing neurological state. The company has also begun European rollout after receiving CE mark in late 2024.

Clinical Advancements

Medtronic’s ADAPT-PD trial, the largest long-term study of aDBS, is evaluating the safety and effectiveness of adaptive DBS models versus continuous DBS. Early data suggests strong brain signal presence across all Parkinson’s phenotypes, both on and off medication.

What’s Next?

Medtronic plans to initiate patient programming in select U.S. healthcare systems in the coming weeks, with nationwide availability in the coming months.

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