BioControl Medical’s FitNeS system gets European approval for treatment-resistant depression

20 May 2014 (Last Updated May 20th, 2014 18:30)

BioControl Medical, with its subsidiary CerebralRx, has obtained CE Mark approval for use of its FitNeS vagus nerve stimulation system as an adjunct therapy for treatment-resistant depression, which has not responded to four or more antidepressant treatments.

BioControl Medical, with its subsidiary CerebralRx, has obtained CE Mark approval for use of its FitNeS vagus nerve stimulation system as an adjunct therapy for treatment-resistant depression, which has not responded to four or more antidepressant treatments.

This is the second indication for FitNeS, with the device previously launched for treatment of drug-resistant epilepsy.

Featuring an implanted stimulator and stimulation lead, the FitNeS vagus nerve stimulation system delivers low-amplitude stimulation signals to the left vagus nerve in a preferentially directional way towards the brain.

"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."

The FitNeS system effectively activates nerve fibres toward the brain, while minimising the activation of non-related nerve fibres and surrounding tissues. This selective approach has the potential to increase stimulation effectiveness, while minimising risk of side-effects.

BioControl Medical is currently working with its distributors to market the FitNeS system in Europe in the near future for treatment-resistant depression. The FitNeS system is not available in the US.

BioControl Medical has also announced that the company is continuing enrolment in the third and final phase of the INOVATE-HF clinical study of its CardioFit system.

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."