FDA approves St. Jude Medical's Brio Neurostimulation system

The FDA announced Friday the approval of St. Jude Medical's Brio Neurostimulation deep brain stimulation (DBS) system, an implantable device to help reduce the symptoms of Parkinson’s disease and essential tremor. The agency said the system "can help some patients when medication alone may not provide adequate relief from symptoms such as walking difficulties, balance problems, and tremors."

"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, 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," he added.

According to the FDA, the system features a small battery-powered, rechargeable electrical pulse generator implanted in the upper chest, with wire leads that attach to electrodes placed within the brain.

The safety and effectiveness of the system was based on study data including two clinical studies, of which one enrolled 136 patients with Parkinson’s disease with the other including 127 patients with essential tremor. Patients from both trials had symptoms, including tremors that were not adequately controlled with drug therapy. The FDA noted that the Brio DBS was used in addition to medication for patients with Parkinson’s disease, while the majority of patients with essential tremor were able to control their symptoms without the need for drugs.

The regulator indicated that the Brio DBS, which gained CE mark for managing the symptoms of intractable primary and secondary dystonia in 2013, is the second device approved by the US agency for Parkinson’s disease and essential tremor, following Medtronic’s Activa DBS system.

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