A new implantable device for patients with partial-onset epilepsy has been approved by FDA. Epilepsy, a brain disorder that causes repeated seizures, is the third most common neurological disease in the United States after stroke and Alzheimer’s disease. According to statistics, epilepsy affects over 2 million Americans.
Crises are disturbances of brain activity that can cause attention and concentration deficit, muscle contractions, fainting or syncope; because these seizures may occur spontaneously, they can affect daily activities of the patient. There are drugs that control these seizures, but there are situations when treatment is no longer effective. In these situations , the remaining options are either brain surgery or implanted devices such as responsive neurostimulator system.
Christy Foreman, director of the Office of Device Evaluation in the FDA ‘s Center for Devices and Radiological Health , said that the neurostimulator detects abnormal electrical activity of the brain and responds by sending electrical stimulation before the patient experiencing seizures. The device is smaller than a cardiac defibrillator and is implanted in the skull through surgery. Responsive neurostimulator system, or RNS, is developed by the company Neuropace, and contains some electrodes that reach the areas of the brain responsible for generating seizures. EEG signals are sent to the device so that detect abnormal electrical activity, then the device sends a small electrical charge to interrupt seizures.
The new device was tested in a study of 191 epilepsy patients in whom treatment was not effective. The study results showed that patients who had switched -on device had a 38% decrease in the monthly rate of seizures, unlike a 17 % decrease that occurred in patients who had the device but had it switched off. It seems that the device was well tolerated and in some patients the seizure rate fell by half. In addition, investigators reported that the decrease in seizure rate continued during the follow -up period of 2 years.
Dr. Dileep Nair, an epileptologist and Section Head of the Cleveland Clinic ‘s Epilepsy Center, said that these patients have no other solution in terms of treatment and that the implantable device offers new hope for them. What is interesting is that the device can be programmed after being implanted; moreover, doctors can monitor patients’ brain activity on a computer in their office, which helps them manage the treatment according to patient needs. “We badly need new, effective therapies for the hundreds of thousands of people in this country as well as the millions around the world who live with uncontrolled seizures,” said Warren Lammert, chairman of the patient advocacy group the Epilepsy Foundation.