FDA Approves Deep Brain Stimulation Device for Parkinson Disease and Essential Tremor

By Kelly Young

Edited by Susan Sadoughi, MD

The FDA has approved a new implantable device to treat symptoms of Parkinson disease and essential tremor.

With the Brio Neurostimulation System, an electrical pulse generator is implanted subdermally in the upper chest and constantly provides low-intensity electrical pulses to electrodes placed at target areas of the brain.

Roughly 140 patients with Parkinson disease who received the implant were assessed at 3 months, while 130 patients with essential tremor were assessed at 6 months. Both groups had symptoms that were not fully controlled with medication. Both groups had a clinically significant reduction of symptoms when the device was turned on, relative to when it was not delivering a signal.

Potential adverse events include intracranial bleeding, infection, and dislocation of the lead.