Cyberonics welcomes strong 2 year VNS data

USA-based therapeutic device firm Cyberonics has welcomed strong data from a pivotal two-year study on the efficacy of adjunctive Vagus Nerve Stimulation therapy on suicidality and worsening depression, reported at the American Psychiatric Association annual meeting in Toronto, Canada.

The study analyzed 235 patients, 205 of whom received VNS over a 24-month period for treatment-resistant depression and evaluated suicides, attempted suicides, suicidal ideation and hospitalizations for worsening depression. Cyberonics, which develops and markets neuromodulating implants for the treatment of epilepsy and other neurological disorders, noted that the study authors found suicidality and hospitalizations due to worsening depression generally declines during 24 months of VNS, particularly in those patients who responded to the treatment.

In July 2005, the US Food and Drug Administration approved VNS as an adjunctive long-term treatment for chronic or recurrent depression in patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more current antidepressant treatments. The product is the first FDA-approved implantable device-based therapy for depression and the first developed, studied, cleared and labeled specifically for patients with TRD, the firm noted.