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FDA Approves Cyberonics’ VNS Therapy(TM) System for Treatment-Resistant Depression (TRD)

The VNS Therapy System be the early FDA-approved implantable device-based conduct bounded by fancy of melancholy and the first treatment modern, studied, accredited and labeled definitely for patients subsequent to treatment-resistant depression (TRD). The VNS Therapy System be approved with means of a treatment for medically refractory epilepsy in Europe in 1994 and in the United States and Canada in 1997 and as a treatment for TRD in Europe and Canada in 2001.

Over 32,000 patients all-embracing hold harvest far-reaching 94,000 forgiving years of undertake with the VNS Therapy System. The VNS Therapy System is immediately commercially unclaimed for the treatment-resistant depression and refractory epilepsy approved use in the United States, European Union and Canada. For more facts next to VNS Therapy for treatment- watertight depression, also as the contraindications, admonitory and precautions, see the Physician’s and Patient’s Manuals and other information at or or ring 1-877-NOW 4 VNS.

Major depressive shambolic is one of the furthermost prevalent and bookish illnesses in the U.S., affecting nearly 19 million Americans both year. According to the National Institute of Mental Health, depression is the main spur of disability in the United States and worldwide. Approximately 20 percent of depressed Americans, or in the command of four million inhabitants, experience unyielding or everyday TRD that have erstwhile to come back with to multiple antidepressant treatment including antidepressant medication, confer psychoanalysis and in every cases, ECT (electroconvulsive therapy).

“Today for the first event, Americans with treatment-resistant depression have an FDA-approved, informatively-labeled, long-term treatment opportunity for their lifelong and life-threatening disease,” observation Robert P. (”Skip”) Cummins, Cyberonics’ Chairman of the Board and Chief Executive Officer. “The refuge and worth of VNS Therapy was demonstrated in in the air to two-year study of patients with the most chronic and resistant depression ever studied. The unprecedented-in-antidepressants article of trade labeling include all the relatable safety and effectiveness facts from the TRD studies and almost 100,000 patient years of epilepsy commercial experience. The TRD labeling will be updated over time by generally unprecedented post-market stakeout, including a 460-patient randomized dose chamber and a 2,000-patient, five-year TRD patient registry to facilitate fully-informed VNS treatment decree by psychiatrist, patients and their kith and kin and payers for years until that time you.

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