Much progress has been made in the treatment of epilepsy, but some forms of the condition, like “refractory epilepsy” cannot be treated by any drugs on the market today.
But Israeli company BioControl Medical (and its spin-off CerebralRx) recently announced the successful trial of FitNeS, an implant designed to treat epilepsy patients with partial onset seizures who do not achieve full seizure control with available prescription drugs.
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BioControl, which already got the medical community’s attention with their CardioFit implant, presented its findings at the American Epilepsy Society 2012 meeting in San Diego. In the five reported cases, the device was successfully implanted in patients and led to an approximate 50 percent reduction in seizures.
“The early results of treatment with FitNeS are very encouraging. Even at relatively high currents, we are seeing positive outcomes in efficacy and an absence of side effects experienced by patients,” says Profesor Elinor Ben-Menachem, the physician monitoring the patients.
Regulating nervous activity
The FitNeS system consists of an implanted stimulator and stimulation lead. The two parts work together to deliver electrical signals through the left vagus nerve, running from the brainstem through the neck and to the chest and abdomen, to calm the overly excited nerve cells in the brain. The system also aims to minimize the activation of non-related nerve fibers and the surrounding tissues.
The FitNeS system was developed to offer a new treatment option for refractory epilepsy patients while delivering improvements over existing vagus nerve stimulation devices. In addition to its potential to increase stimulation efficacy and minimize side effects, the FitNeS system was designed to employ lower currents, minimize nerve damage through a unique nerve electrode interface, reduce current leakage through improved cuff isolation, and allow for safe and easy explant of the electrode if required.
The FitNeS device is not BioControl’s first medical breakthrough; CardioFit, the device designed to improve cardiac function in patients with congestive heart failure has “already been approved in Europe and waiting for the FDA approval to do a worldwide launch,” says CEO Ehud Cohen. “We see tremendous global opportunity for our technology in treating both heart disease and neurological disorders, and we look forward to a strong future of growth in both areas,” Cohen concludes.
The FitNeS system has CE marking and is available in Europe through CerebralRx, which holds exclusive rights to BioControl Medical’s platform vagus nerve stimulation technology for treating neurological disorders. FitNeS is not available in the United States.
Photo by CerebralRx