The U.S. Food and Drug Administration (FDA) on Friday, June 12 announced that it has approved an implantable deep brain stimulation device called the Brio Neurostimulation System, designed to help reduce symptoms associated with Parkinson’s disease and essential tremor, the latter a movement disorder and one of the most common causes of tremors.
The FDA says the Brio Neurostimulation System, designed and marketed by manufactured by St. Jude Medical headquartered in St. Paul, Minnesota, can help some patients when medication alone may not provide adequate relief from neuromotor symptoms such as walking difficulties, balance problems, and tremors.
According to the National Institutes of Health estimates, about one million Americans have Parkinson’s disease, and some 50,000 Americans are diagnosed with Parkinson’s annually. Essential Tremor affects several million Americans as well. Parkinson’s disease and Essential Tremor are neurological disorder that typically afflicts people over age 60 and those over age 40 respectively.
In its 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 and less effective. People with late stage Parkinson’s disease have many disabling 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. In Parkinson’s, cells in the brain that produce a chemical called dopamine become impaired or die. Dopamine is a neurotransmitter that carries signals between the areas of the brain that regulate and control smooth, purposeful motor movement when performing routine tasks like eating, writing and shaving.
Essential Tremor most often affects the hands and arms and is typically slowly progressive, starting on one side of the body and 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, while with the remainder of cases the cause is unknown.
“There are no cures for Parkinson’s disease or Essential Tremor, but finding better ways to manage symptoms is essential for patients,” says 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.”
Neurostimulation is a relatively new medical field enabled by advances in microelectronics technology. It works by intercepting pain signals before they reach the brain. To do this, a small system is implanted within the body. This system, similar to a cardiac pacemaker, is used to replace pain with a different feeling. Some people describe this feeling as a gentle massaging sensation or, in some cases, simply the absence of pain.
With neurostimulation, when pain signals travel up the spinal cord to the brain a generator sends pulses to a wire lead that delivers them to nerves along the spinal cord, thereby blocking the pain signals before they reach the brain, and with the painful feeling replaced with a more pleasant sensation.
The Brio Neurostimulation System consists of a small (1.9in x 2.1in x 0.4in) battery-powered, rechargeable electrical pulse generator that is implanted surgically under the skin of the upper chest, with wire leads that attach to electrodes placed at specific locations in the brain depending on whether the device is being used to treat Parkinson’s disease or Essential Tremor. As described above, the device’s electrical pulse generator continuously delivers low intensity electrical pulses to brain’s target areas. Health care providers can adjust the pulse generator’s settings to optimize the Brio Neurostimulation System’s therapeutic effects.
The FDA notes that data supporting the safety and effectiveness of the Brio Neurostimulation device system included two clinical studies, one of which included 136 patients with Parkinson’s disease and the other 127 patients with Essential Tremor. Both studies enrolled patients suffering with neuromotor symptoms, including tremors, that were not being adequately controlled with drug therapy.
With the Brio Neurostimulation System used complementarily to medication, the FDA reports that patients with Parkinson’s disease were able to control their tremor symptoms. The majority of patients with essential tremor who used the device were able to do likewise without need of medication. Researchers implanted the Brio Neurostimulation System in all patients. Patients with Parkinson’s disease were assessed for the Brio device’s effectiveness at three months and essential tremor patients at six months.
The FDA reports that both groups experienced statistically significant improvement on their primary effectiveness endpoint when the device was turned on compared to when it was turned off.
Serious adverse events associated with the Brio device’s implantation 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.
St. Jude Medical is a Fortune 500 company that conducts business using a network of more than 20 principal operations and manufacturing facilities with some 16,000 employees worldwide, making products sold in more than 100 countries, and annual revenues of $5.6 billion. The company develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide, with a major focus on four areas: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation.
Noting that Parkinson’s, Dystonia (neurological movement disorder, in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures), and other neurological diseases take a devastating emotional and economic toll on patients and their families, as pioneers in the field, St. Jude Medical has developed cutting-edge neuromodulation technologies for the treatment of neurological disorders. In Europe, the company’s proprietary deep brain stimulation therapy helps patients and their families manage symptoms of Parkinson’s disease and Dystonia, thereby regaining some degree of improved independence and peace of mind.
The Brio Neurostimulation System is the second device approved by the FDA for Parkinson’s and essential tremor. The first device, Medtronics Activa Deep Brain Stimulation Therapy System, was approved in 1997 for tremor associated with Essential Tremor, Dystonia, and Parkinson’s disease. In 2002, the indications were expanded to include other symptoms of Parkinson’s disease.
U.S. Food and Drug Administration (FDA)
St. Jude Medical
National Institutes of Health
National Institute of Neurological Disorders and Stroke
St. Jude Medical, Inc.