The FDA has approved the Brio Neurostimulation System to help reduce the symptoms of Parkinson’s disease and essential tremor, a movement disorder that is one of the most common causes of tremors.
The system is an implantable deep brain stimulation device and can help patients for whom medication alone may not provide relief from symptoms such as walking difficulties, balance problems and tremors.
William Maisel, office of device evaluation at the FDA’s Center for Devices and Radiological Health, said: “There are no cures Parkinson’s disease or essential tremor, but finding better ways to manage symptoms is essential for patients.
“This new device adds to the array of treatment options to help people living with Parkinson’s and essential tremor enjoy better, more productive lives.”
The Brio Neurostimulation System consists of a small battery-powered, rechargeable electrical pulse generator implanted under the skin of the upper chest and has wire leads that attach to electrodes positioned within the brain at specific points, dependent on what the patient requires treatment for.
The electrical pulse generator continuously delivers low intensity electrical pulses to target areas in the brain.
Data from two clinical trials supported the application, one with 136 Parkinson’s patients and the other with 127 patients with essential tremor. In both studies, the device, in addition to medication, was found to control or improve their symptoms without the needs for further medications.
The device is the second of its kind to be approved by the FDA for Parkinson’s and essential tremor, the first being Medtronic’s Activa Deep Brain Stimulation Therapy System which was approved in 1997.