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VBCN - July 2015 Volume 2, No 2 - FDA News & Updates

The FDA approved the Brio Neurostimulation System, an implantable deep brain stimulation device manufactured by St Jude Medical, St Paul, MN, to help reduce the symptoms of Parkinson’s disease and essential tremor.

“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, Director, Office of Device Evaluation, FDA Center for Devices and Radiological Health, Silver Spring, MD. “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’s safety and efficacy were based on 2 clinical trials. One clinical trial included 136 patients with Parkinson’s disease, and the other clinical trial included 127 patients with essential tremor. The patients in both studies had symptoms that could not be controlled adequately with drug therapy, including tremors.

The Brio Neurostimulation System was implanted into all of the patients, and the researchers assessed the device’s effectiveness in patients with Parkinson’s disease and in those with essential tremor at 3 and 6 months, respectively. The patients with Parkinson’s disease used the device in addition to their medications, and the majority of patients with essential tremor who used the device were able to control their symptoms without needing medications. The primary efficacy end point improved significantly in both groups when the device was turned on versus when it was turned off.

One serious adverse event associated with the device included intracranial bleeding, which can lead to stroke, paralysis, or death. Other device-related adverse events included infection and the device lead becoming dislocated under the skin. (June 12, 2015)

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Last modified: August 5, 2015
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