The US Food and Drug Administration (FDA) has approved the Brio Neurostimulation System (St Jude Medical), an implantable deep brain stimulation system, to reduce the symptoms of Parkinson’s disease (PD) and essential tremor (ET).
The system is the second such device approved for these indications, an FDA statement notes. The first one, the Activa Deep Brain Stimulation Therapy System (Medtronic), was approved in 1997 for tremor associated with PD and ET. In 2002, the indications were expanded to include the symptoms of PD.
“The Brio Neurostimulation System can help some patients when medication alone may not provide adequate relief from symptoms such as walking difficulties, balance problems, and tremors,” the statement notes.
“There are no cures for Parkinson’s disease or essential tremor, but finding better ways to manage symptoms is essential for patients,” said William Maisel, MD, MPH, acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “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 system consists of a small, battery-powered, rechargeable electrical pulse generator (about 1.9 x 2.1 x 0.4 inches) that is implanted under the skin of the upper chest, and wire leads that are attached to electrodes placed in the brain at different locations, depending on whether it’s being used to treat PD or ET, the statement notes.
Data supporting its use come from two clinical trials of the device, one in 136 PD patients and the other in 127 patients with ET. In both studies, symptoms were not adequately controlled with medication. The system was used as an adjunct to medication for the patients with Parkinson’s, while “the majority of patients with essential tremor who used the device were able to control their symptoms without the need for medications,” the FDA said.
All patients in the studies were implanted with the system; PD patients were evaluated at 3 months, and the ET patients after 6 months of therapy. “Both groups showed statistically significant improvement on their primary effectiveness endpoint when the device was turned on compared to when it was turned off,” the statement notes.
Serious adverse events included intracranial bleeding, which can lead to stroke, paralysis, or death, the statement adds. Other adverse events deemed device-related included infection, and dislocation of the device lead under the skin.