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FDA Approves Brain Implant to Help Reduce Parkinson’s Disease and Essential Tremor
The FDA has given the green light to the Brio Neurostimulation System, an implantable deep-brain stimulation device to help reduce the symptoms of Parkinson’s disease (PD) and essential tremor. The implant can help some PD patients when medication alone may not provide adequate relief from symptoms, such as walking difficulties, balance problems, and tremors, the product’s developer (St. Jude Medical) announced.
An estimated 50,000 Americans are diagnosed with PD each year, according to the National Institutes of Health, and approximately 1 million Americans have the condition. The neurological disorder typically occurs in people over 60 years of age, when cells in the brain that produce dopamine become impaired or die. Dopamine helps transmit signals between the areas of the brain that produce smooth, purposeful movement, such as eating, writing, and shaving.
Essential tremor affects several million people and usually occurs in those more than 40 years old. “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 Brio Neurostimulation System consists of a small (1.9-inch × 2.1-inch × 0.4-inch) battery-powered, rechargeable electrical pulse generator (EPG) implanted under the skin of the upper chest along with wire leads that attach to electrodes placed within the brain at specific locations depending on whether the device is being used to treat PD or essential tremor. The EPG continuously delivers low-intensity pulses to target areas in the brain. Health care providers can make adjustments to the EPG to optimize the effects of the implant system.
Data supporting the safety and effectiveness of the Brio Neurostimulation System were obtained from two pivotal studies. One study included 136 patients with PD, and the other included 127 patients with essential tremor. In both trials, the patients had symptoms (including tremors) that were not adequately controlled with drug therapy.
The Brio Neurostimulation System was used in addition to medications for patients with PD, and most of the patients with essential tremor who used the device were able to control their symptoms without the need for medications. Researchers assessed the effectiveness of the implant system for patients with PD at 3 months and for patients with essential tremor at 6 months. Both groups showed statistically significant improvements on their primary effectiveness endpoint when the device was turned on compared with when it was turned off.
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 the second device approved by the FDA for the treatment of PD and essential tremor. The first device, the Activa Deep Brain Stimulation Therapy System (Medtronic), was approved in 1997 for tremor associated with essential tremor and PD. In 2002, the device’s indications were expanded to include the symptoms of PD.
In its early stages, PD typically affects one side of the body and starts as problems with movement, stiffness, and mild tremors. People with late-stage PD 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.
Essential 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, tongue (affecting the voice), legs, and trunk. Approximately half of essential tremor cases result from a genetic mutation. For the remainder of cases, the cause is unknown.
Source: FDA; June 12, 2015.