FDA Approves Second Brain Implant for Parkinson’s Symptoms

St. Jude Medical’s implant joins one made by Medtronic for treating Parkinson’s symptoms

The Food and Drug Administration on Friday approved a second brain implant to help reduce the symptoms of Parkinson’s disease.

By MARIA ARMENTAL

June 12, 2015 6:05 p.m. ET

The Brio Neurostimulation System is manufactured by St. Jude Medical in St. Paul, Minn.

The FDA in 1997 approved Medtronic PLC’s Activa Deep Brain Stimulation Therapy System for tremors associated with essential tremor and Parkinson’s disease, and expanded it in 2002 to include other symptoms of Parkinson’s disease.

Parkinson’s is a neurological disorder that afflicts about one million Americans. An estimated 50,000 Americans are diagnosed with Parkinson’s each year, according to the National Institutes of Health.

There are no cures for Parkinson’s or essential tremor, a condition previously called benign essential tremor characterized by uncontrolled muscle movement.

Parkinson’s is typically diagnosed in people over 60 years old, while essential tremor usually occurs in those over 40.

The implant includes a battery-powered, rechargeable electrical pulse generator that is implanted under the skin of the upper chest and wire leads that are attached to electrodes placed within the brain, the FDA said. Serious adverse events include intracranial bleeding, which can lead to stroke, paralysis or death, the agency warned. Other adverse events included infection and dislocation of the device lead under the skin.

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St. Jude's Brain Implant For Parkinson's Disease Gets FDA Approval 

6/12/2015 10:48 PM ET 

St. Jude Medical Inc.'s (STJ) Brio Neurostimulation System has been approved by the FDA to help reduce the symptoms of Parkinson's disease and essential tremor, becoming the second such device to get the regulatory go-ahead.

Parkinson's disease, which typically occurs in people over age 60, when cells in the brain that produce a chemical called dopamine become impaired or die, is a neurological disorder for which there are no cures. 

The Brio Neurostimulation System is an implantable deep brain stimulation device consisting of a small battery-powered, rechargeable electrical pulse generator implanted under the skin of the upper chest and wire leads that attach to electrodes placed within the brain at specific locations. The device is meant to help patients when medication alone may not provide adequate relief from symptoms such as walking difficulties, balance problems, and tremors. 

Medtronic's Activa Deep Brain Stimulation Therapy System, was the first device to be approved by the FDA in 1997 for tremor associated with essential tremor and Parkinson's disease, and in 2002, the approval was expanded to include the symptoms of Parkinson's disease.

STJ closed Friday's trading at $74.34, down 1.06%. 

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