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Home » FDA approves St. Jude Medical’s Brio brain implant

FDA approves St. Jude Medical’s Brio brain implant

June 15, 2015 By Brad Perriello

stjude-medical-1x1(Reuters) — The FDA last week said it approved a brain implant from St. Jude Medical (NYSE:STJ) that helps reduce symptoms of Parkinson’s disease and essential tremor, a neurological disorder that causes rhythmic shaking.

The Brio neurostimulation device is an implantable small generator that delivers low intensity electrical pulses to target areas in the brain, according to the FDA. The Brio system won CE Mark approval in the European Union in September 2009 and Australian approval in March 2010.

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 June 12.

“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 & Radiological Health, said in prepared remarks. “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 implant is the 2nd device approved for the indication after Medtronic‘s (NYSE:MDT) Activa deep-brain stimulation device.

About 50,000 Americans are affected by Parkinson’s each year, according to the National Institutes of Health.

STJ shares closed up a hair at $74.34 apiece June 12.

Filed Under: Food & Drug Administration (FDA), Neuromodulation/Neurostimulation, Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: Parkinson's disease

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