The Medtronic Percept PC is the first FDA-approved deep brain stimulation (DBS) system with bidirectional sensing capability — it both delivers therapeutic electrical stimulation to deep brain structures and simultaneously records local field potentials (LFP) via BrainSense technology. This enables clinicians to detect beta-band oscillations associated with Parkinson's motor symptoms and log them over time for personalized programming. Approved in July 2020 for Parkinson's disease, essential tremor, and epilepsy. The neurostimulator is implanted in the chest, connected by leads to electrodes in the subthalamic nucleus or globus pallidus.
The device has received Pre-Market Approval (PMA) from the FDA, the most stringent device marketing pathway. PMA approval means FDA has found there is reasonable assurance the device is safe and effective.
FDA Device Regulatory Guidance ↗