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European Approval For BioControl Medical’s Nerve Stimulation System For Treatment-Resistant Depression

BioControl Medical’s FitNeS vagus nerve stimulation system now has a second approved European indication: treatment-resistant depression. This follows the implantable neuromodulation system’s first CE mark for drug-resistant epilepsy in 2010.

The FitNeS vagus nerve stimulation system from Israel-based BioControl Medical Ltd. now has a second approved European indication: treatment-resistant depression (TRD). This follows the implantable neuromodulation system’s first CE mark for drug-resistant epilepsy (DRE) in 2010. Sister company [CerebralRx Ltd.] is commercializing the product for both indications.

TRD is classified as a major depressive disorder that has not responded to four or more classes of antidepressant drugs. Patients with TRD currently have no solution other than to continue to take medication, according to Ehud Cohen, PhD, BioControl’s chief executive officer

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