An implantable deep brain stimulation device for patients with Parkinson’s disease and essential tremor has been approved by the U.S. Food and Drug Administration, according to an FDA news release. The device, called the Brio Neurostimulation System, was approved June 12 and helps some patients when medication alone does not provide adequate relief from walking difficulties, balance problems and tremors.
New treatment option
The BNS is a small battery-powered, rechargeable electrical pulse generator implanted under the skin of the upper chest. Wire leads that attach to electrodes placed within the brain at specific locations depending on whether the device is being used to treat Parkinson’s disease or essential tremor, according to the release. The device delivers low intensity electrical pulses to target areas in the brain, with adjustments made by healthcare providers.
“There are no cures for Parkinson’s disease or essential tremor, but finding better ways to manage symptoms is essential for patients,” William Maisel, MD, MPH, acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said in the release. “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.”
Two clinical studies tested the device’s safety and effectiveness at three months and again at six months. One involved 136 patients with Parkinson’s disease, the other studied 127 patients with essential tremor. Patients in both groups had symptoms not controlled adequately with drug therapy. Results showed the majority of patients with essential tremor did not need medication while using the device. Patients with Parkinson’s disease used the device and their medication to control symptoms.
Both groups showed statistically significant improvement on their primary effectiveness endpoint when the device was turned on compared with when it was turned off, according to the press release. Adverse events included intracranial bleeding, infection and dislocation of the device lead under the skin.
The BNS is the second device approved by the FDA for Parkinson’s and essential tremor. The first, Medtronic’s Activa Deep Brain Stimulation Therapy System, was approved in 1997 for tremors, according to the release.
Each year, about 50,000 people are diagnosed with Parkinson’s disease, according to the National Institutes of Health, and close to one million have the condition. While Parkinson’s disease typically affects people over 60, essential tremor affects several million people and usually occurs in those over age 40.
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