The US Food and Drug Administration (FDA) has authorised St Jude Medical to use its Brio Neurostimulation system for reducing the symptoms of Parkinson’s disease and essential tremor.
Consisting of a small battery powered, re-chargeable electrical pulse generator, the Brio Neurostimulation system is an implantable deep brain stimulation device that is designed to help patients when medication alone is unable to provide adequate relief from symptoms such as walking difficulties, balance problems,and tremors.
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The generator is implanted under the skin of the patient’s upper chest and wire leads 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 generator continuously delivers low intensity electrical pulses to target areas in the brain, and can be adjusted by healthcare providers to optimise the effects of the system.
FDA Center for Devices and Radiological Health Device Evaluation Office acting director William Maisel said: “There are no cures for Parkinson’s disease or essential tremor, but finding better ways to manage symptoms is essential for patients.
“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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By GlobalDataApproval was based on results obtained from two clinical studies, the first of which included 136 patients with Parkinson’s disease and the other featured 127 patients with essential tremor.
During the study, the system was used in addition to medication for patients with Parkinson’s disease for three months, and essential tremor patients for six months.
Both groups were able to control their symptoms without the need for medications, and showed significant improvement on their primary effectiveness endpoint when the device was turned on compared to when it was turned off.
Brio Neurostimulation system is the second device approved by the FDA for Parkinson’s and essential tremor.
The agency approved Medtronic‘s Activa Deep Brain Stimulation Therapy system for tremor associated with essential tremor and Parkinson’s disease in 1997.
Image: An illustration of Brio Deep Brain Stimulation system for treating Parkinson’s disease. Photo: courtesy of St Jude Medical.
