Israel-based BioControl Medical has announced that the company, together with its spin-off CerebralRx, has gained CE Mark approval for use of its FitNeS vagus nerve stimulation system as an adjunct therapy for treatment resistant depression.
Treatment resistant depression is depression that has not responded to four or more antidepressant treatments.
This is the second indication for the FitNeS vagus nerve stimulation system. Previously the system was introduced for the treatment of drug-resistant epilepsy.
The FitNeS vagus nerve stimulation system features an implanted stimulator and stimulation lead that work together to deliver electrical signals to the left vagus nerve. The system delivers low amplitude stimulation signals to the left vagus nerve in a preferentially directional way toward the brain.
It activates nerve fibres toward the brain, while minimizing the activation of non-related nerve fibres and surrounding tissues. This selective approach has the potential to increase stimulation effectiveness, while minimizing risk of side effects.
BioControl Medical is currently working with its distributors to market the FitNeS system in Europe in the near future. The FitNeS system is not available in the US.
The company said that it is also continuing enrolment in the third and final phase of the INOVATE-HF clinical study of its CardioFit system, which is based on the same underlying technology as FitNes.
CardioFit system is an implantable electrical stimulation device designed to improve heart function in patients with congestive heart failure.
Washington University in St. Louis INOVATE HF steering committee co-chairman Doug Mann said: "The INOVATE-HF study enrolment rate continues to exceed expectations, and we are pleased to report that more than 425 patients have been enrolled and 230 implanted with the CardioFit vagal nerve stimulation device thus far."