FDA Approves St. Jude`s Brain Implant for Parkinson`s Disease

By Reuters Staff

The U.S. Food and Drug Administration on Friday approved a brain implant from St. Jude Medical Inc that helps reduce symptoms of Parkinson's disease and essential tremor.

The device, Brio Neurostimulation System, is an implantable small generator that delivers low intensity electrical pulses to target areas in the brain.

The device can be used when medication alone may not provide adequate relief from symptoms such as walking difficulties, balance problems, and tremors associated with the two movement disorders, the FDA said.

An estimated 50,000 Americans are diagnosed with Parkinson's disease each year, according to the National Institutes of Health, and about one million Americans have the condition. Essential tremor affects several million people and usually occurs in those over age 40.

"There are no cures for Parkinson's disease or essential tremor, but finding better ways to manage symptoms is essential for patients," Dr. William Maisel, acting director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said in a statement.

"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.

The implant is the second device approved for the indication after Medtronic Plc's Activa Deep Brain Stimulation Therapy System.

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