The Brio Neurostimulation System is "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 FDA said in a news release.
FRIDAY June 12, 2015, 2015 -- The U.S. Food and Drug Administration on Friday approved a device that can be implanted into the brain to help people battling Parkinson's disease.The agency estimates that about 50,000 Americans are diagnosed with Parkinson's annually, while essential tremor affects "several million" people, most over the age of 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 the news release.
," Dr. William Maisel, acting director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said in the news release.
"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 said.
The device is consists of a small, rechargeable battery-powered "pulse generator" implanted under the skin. Wire leads from the generator lead to specific brain locations, depending on the illness under treatment. People trained in using the devices can adjust the pulse generator's effects as needed, the FDA said.
under treatment. People trained in using the devices can adjust the pulse generator's effects as needed, the FDA said.
The Brio Neurostimulation System was approved based on the results of two clinical trials, one involving 136 patients with Parkinson's disease who used the device for three months, and another involving 127 patients with essential tremor who used it for six months. In both studies, medications had already failed to control patients' symptoms, the FDA said.
"Both groups showed statistically significant improvement
on their primary effectiveness endpoint when the device was turned on, compared to when it was turned off," the agency said.
on their primary effectiveness endpoint when the device was turned on, compared to when it was turned off," the agency said.
The device does not come without risk, including intracranial bleeding which can lead to stroke, paralysis or death, the FDA said. Infection and device dislocation are also potential risks.
"Brio Neurostimulation System is the second device approved by the FDA for Parkinson's and essential tremor," the agency said. "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."
http://health.einnews.com/article/270588895/vQUz7G3cxQBVl3pR
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FDA approve brain implant for treating symptoms of Parkinson's
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| The new device helps to reduce symptoms of Parkinson's disease and essential tremor by sending low-intensity electrical pulses to electrodes in the brain. |
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US Food and Drug Administration have given approval to an implantable brain stimulation device for reducing the symptoms of Parkinson's disease and essential tremor when medication alone is unable to provide adequate relief.The Brio Neurostimulation System is the second device to be approved by the US Food and Drug Administration (FDA) for treating these disorders and can reduce symptoms such as balance problems, tremors and walking difficulties.
"There are no cures for Parkinson's disease or essential tremor, but finding better ways to manage symptoms is essential for patients," says Dr. William Maisel of the FDA. "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."
Around one million people in the US are believed to have Parkinson's disease, with an estimated 50,000 people newly diagnosed with the progressive nervous system disorder each year.
Parkinson's disease symptoms are caused by the degeneration of nerve cells that produce the neurotransmitter dopamine, a chemical that helps transmit messages from the brain related to the control and coordination of body movements.
The cause of essential tremor is currently unknown, but the condition leads to involuntary shaking - typically in the hands - that is similar to that caused by Parkinson's disease. The condition affects several million people in the US, mostly over the age of 40.
Drugs are frequently used to reduce tremors in people with Parkinson's disease and essential tremor, but sometimes medicine is unable to adequately alleviate disruptive symptoms. When this is the case, the new Brio Neurostimulation System could be of use.
A battery-powered generator that sends electrical pulses to the brain
Manufactured by St. Jude Medical in St. Paul, MN, the device consists of a small electrical pulse generator implanted under the skin of the upper chest. The generator is connected to electrodes positioned within the brain according to whether the device is being used to treat Parkinson's disease or essential tremor.
The battery-powered pulse generator is fully rechargeable and delivers low-intensity electrical pulses to these electrodes through wires. Health care providers can adjust the activity of the pulse generator in order to maximize the effects for the patients using the device.
Among the data presented to the FDA to demonstrate the safety and efficacy of the device were two clinical studies: one involving 136 participants with Parkinson's disease and one involving 127 patients with essential tremor.
In both studies, the participants were experiencing tremors that were not being adequately relieved by medication. After 3 months for the patient with Parkinson's disease and 6 months for the patients with essential tremor, the researchers assessed the effectiveness of the device.
For both groups of patients, significant improvement in symptoms was noted when the device was turned on compared with when the device was turned off. In the patients with Parkinson's disease, the device was used alongside medication while the majority of patients with essential tremor could manage their symptoms without additional drug therapy.
A number of adverse events related to use of the device were observed by researchers. These ranged from infection and dislocation of the device under the skin to more severe events such as intracranial bleeding. These events occurred infrequently enough, however, for the FDA approve the device.
Earlier this year, Medical News Today reported on a study finding that difficult Parkinson's symptoms such as swallowing dysfunction and freezing of gait respond were improved more with low-frequency deep brain stimulation compared with the more usual high-frequency brain stimulation.
Written by James McIntosh
Copyright: Medical News Today
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