FDA Okays implant for reducing Parkinson's disease
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The US Food and Drug Administration (FDA) has approved the Brio Neurostimulation System (St Jude Medical), an implantable deep brain stimulation system, to reduce the symptoms of Parkinson's disease (PD) and essential tremor (ET).
The system is the second such device approved for these indications, an FDA statement notes. The first one, the Activa Deep Brain Stimulation Therapy System (Medtronic), was approved in 1997 for tremor associated with PD and ET. In 2002, the indications were expanded to include the symptoms of PD.
"The Brio Neurostimulation System can help some patients when medication alone may not provide adequate relief from symptoms such as walking difficulties, balance problems, and tremors," the statement notes.
"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, 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."
The system is the second such device approved for these indications, an FDA statement notes. The first one, the Activa Deep Brain Stimulation Therapy System (Medtronic), was approved in 1997 for tremor associated with PD and ET. In 2002, the indications were expanded to include the symptoms of PD.
"The Brio Neurostimulation System can help some patients when medication alone may not provide adequate relief from symptoms such as walking difficulties, balance problems, and tremors," the statement notes.
"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, 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."
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