FDA: The U.S. Food and Drug Administration today approved the Brio Neurostimulation System, an implantable deep brain stimulation device to help reduce the symptoms of Parkinson’s disease and essential tremor, a movement disorder that is one of the most common causes of tremors. 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.
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. The neurological disorder typically occurs in people
over age 60, when cells in the brain that produce a chemical called
dopamine become impaired or die. Dopamine helps transmit signals between
the areas of the brain that produce smooth, purposeful movement -- like
eating, writing and shaving.
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,” said William Maisel,
M.D., M.P.H., 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.”
Brio Neurostimulation System consists of a small (1.9in x 2.1in x
0.4in) 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 depending on
whether the device is being used to treat Parkinson’s disease or
essential tremor. The electrical pulse generator continuously delivers
low intensity electrical pulses to target areas in the brain. Health
care providers make adjustments to the pulse generator to optimize the
effects of the Brio Neurostimulation System.
Data supporting the
safety and effectiveness of the device system included two clinical
studies. One study included 136 patients with Parkinson’s disease and
the other included 127 patients with essential tremor. In both studies,
patients had symptoms, including tremors, that were not adequately
controlled with drug therapy.
The Brio Neurostimulation System
was used in addition to medication for patients with Parkinson’s disease
and the majority of patients with essential tremor who used the device
were able to control their symptoms without the need for medications.
Researchers implanted the Brio Neurostimulation System in all patients
and assessed effectiveness for Parkinson’s disease patients at three
months and essential tremor patients at six months. Both groups showed
statistically significant improvement on their primary effectiveness
endpoint when the device was turned on compared to when it was turned
Serious adverse events included intracranial bleeding, which
can lead to stroke, paralysis or death. Other device-related adverse
events included infection and dislocation of the device lead under the
skin. The Brio Neurostimulation System is manufactured by St. Jude
Medical in St. Paul, Minnesota.
Brio Neurostimulation System is
the second device approved by the FDA for Parkinson’s and essential
tremor. The first device, Medtronic’s Activa Deep Brain Stimulation
Therapy System, was approved in 1997 for tremor associated with
essential tremor and Parkinson’s disease. In 2002, the indications were
expanded to include the symptoms of Parkinson’s disease.
early stages, Parkinson’s disease typically affects one side of the body
and starts as problems with movement, stiffness, and mild tremors.
Gradually, the symptoms can affect both sides of the body and
medications may become less effective. People with late stage
Parkinson’s disease have many symptoms including: trouble walking,
impaired posture and balance, muscle stiffness and tremors in the arms
and hands that make it difficult to perform everyday tasks.
tremor most often affects the hands and arms and can be slowly
progressive, starting on one side of the body but eventually affecting
both sides. Hand tremor is the most common symptom, but tremors can also
affect movement in the head, arms, voice, tongue, legs, and trunk.
About half of essential tremor cases result from a genetic mutation. For
the remainder of cases, the cause is unknown.
The FDA, an agency
within the U.S. Department of Health and Human Services, protects the
public health by assuring the safety, effectiveness, security of human
and veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency is also responsible for the safety
and security of our nation’s food supply, cosmetics, dietary
supplements, products that give off electronic radiation, and for
regulating tobacco products.