FDA this month approved the Brio Neurostimulation System (St. Jude Medical), an implantable deep brain stimulation device, to help reduce the symptoms of Parkinson’s disease and essential tremor. It is the second device approved by the FDA for PD and ET.
The Brio Neurostimulation System, measuring 1.9in x 2.1in x 0.4in, is implanted under the skin of the upper chest with wire leads that attach to electrodes placed within the brain. The system was evaluated in a study of 136 patients with Parkinson’s disease and a study of 127 patients with essential tremor. Patients with Parkinson’s continued to use medication following device implantation, while the majority of ET patients did not use medication. At six months post-implantation, both groups showed statistically significant improvement in primary effectiveness endpoints when the device was turned on compared to 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.
“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.
In a previous interview with Practical Neurology™ magazine, Michele Tagliati, MD, Director of the Movement Disorders Program in the Department of Neurology at Cedars-Sinai Medical Center, talked about issues involved with short- and long-term management of deep brain stimulation. “Particularly in Parkinson’s disease we can be very successful for many years” managing symptoms medically, Dr. Tagliati observed. DBS is used when medical treatment is no longer sufficient.
The Brio Deep Brain Stimulator from St. Jude Medical.
Use of DBS can be beneficial once the proper settings are in place. “In the short term we have to work, sometimes pretty hard, to find the electrical settings that will stop the tremor, that will help the patients relieve their stiffness or their slowness of movement,” Dr. Tagliati says. This can take hours or up to three months, he says.n