Patients with Parkinson's disease can now opt to use a new device that can help alleviate their symptoms.
The U.S. Food and Drug Administration (FDA) announced the approval of the Brio Neurostimulation System developed by St. Jude Medical in St. Paul, Minnesota, which is said to help patients whose essential tremors and Parkinsonian symptoms cannot be relieved by medications alone.
The Brio Neurostimulation System is comprised of electrodes, wires and a small electrical pulse generator that is powered by batteries. The device is placed under the skin of the upper chest.
The wires attached to the device are then connected to the brain electrodes, which are systematically implanted within the different areas of the brain, depending on the nature of the symptoms being treated. The generator constantly administers electrical pulses, which the assigned healthcare providers may adjust to fully suit the patient's individual needs.
Two clinical trials were performed to test the safety and efficacy of the system. There were two study groups involved in the testings. The first group was composed of 136 individuals with Parkinson's disease and the other group had 127 patients with essential tremors. Both groups had symptoms that medication alone could not relieve.
The evaluation of the system's effectiveness was conducted for three months among patients with Parkinson's disease and six months among those with essential tremors.
After the device was used for both study groups for the specific period of time, the experts found that most of the patients with essential tremors and those who have Parkinson's disease exhibited improvements in terms of controlling their symptoms even without the help of drug therapy.
When the device was turned on, the patients felt the apparent improvements in their clinical conditions.
"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, 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 Brio Neurostimulation System may, however, cause infection if the device is placed incorrectly under the skin. The system may also pose serious adverse effects, such as intracranial bleeding, which may subsequently result in stroke, paralysis or death.
The Brio Neurostimulation System is the second device to receive approval from the FDA for the treatment of Parkinson's disease and essential tremor. In 1997, a device called Activa Deep Brain Stimulation Therapy System was also approved by the agency for the management of the same symptoms.
Photo: Pedro Ribeiro Simões | Flickr
