The Food and Drug Administration (FDA) has approved the St. Jude Medical’s Brio Neurostimulation System, a deep brain stimulation implant to help reduce the symptoms of Parkinson’s disease and essential tremor in patients when medication alone may not provide adequate relief from symptoms (eg, walking difficulties, balance problems, tremors). This is the second device that is FDA-approved for Parkinson’s and essential tremor.
The Brio Neurostimulation System is a small battery-powered, rechargeable electric pulse generator (1.9in x 2.1in x 0.4in) that is implanted under the skin of the upper chest. The wire leads that attach to electrodes are placed at specific locations within the brain based on whether the treatment is for Parkinson’s disease or essential tremor. The pulse generator continuously sends low intensity electrical pulses to target areas in the brain. Clinicians can adjust the pulse generator to optimize the effects.
Data from two clinical studies supported the safety and efficacy of the device system; one study evaluated patients with Parkinson’s disease (n=136), and the other evaluated patients with essential tremor (n=127). Patients were implanted with the Brio Neurostimulation System and efficacy was assessed at three months for Parkinson’s disease patients and at six months for essential tremor patients. Across both studies, patients showed statistically significant improvement on their primary efficacy endpoint when the device was turned on vs. off.
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