Final FDA approval of vagus nerve stimulation as a therapy for chronic or recurrent treatment-resistant depression to be issued in May. Psychiatrists will then officially be able to prescribe this remarkable, life changing therapy for patients.
On April 7th, 2005, the manufacturer of the vagus nerve stimulator( Cyberonics, Inc.) announced that it had been notified by the U.S. Food and Drug Administration(FDA) that one the few remaining conditions of final FDA approval had been satisfied. Cyberonics also announced that it was very confident that the two remaining conditions will be expeditously satisfied and that final FDA approval will be issued in May.
Robert P. (â€śSkipâ€ť) Cummins, Cyberonicsâ€™ Chairman of the Board and Chief Executive Officer commented: â€śThis major step forward towards the accomplishment of Cyberonicsâ€™ mission to improve the lives of people touched by refractory epilepsy and treatment-resistant depression (TRD) would not have been possible without the timely, diligent, interactive and cooperative efforts of the entire Dallas District Office staff led by Michael Chappell, District Director, and the Cyberonics regulatory team. Cyberonics and CDRH continue to make good progress towards our goal of satisfying the remaining conditions of final TRD approval.â€ť
The official launch of vagus nerve stimulation as a treatment for depression will take place at the American Psychiatric Association's Annual Meeting at the World Congress Center in Atlanta from May 21st to May 25th. The Annual Meeting will be attended by over 20,000 psychiatrists.
Major depressive disorder is one of the most prevalent and serious illnesses in the U.S., affecting nearly 19 million Americans every year. Depression is the second leading cause of disability for the general population and the leading cause of disability for American women. Approximately 20 percent of depressed Americans, or approximately four million people, experience chronic or recurrent treatment-resistant depression that has failed to respond to multiple antidepressant treatments. If approved, the VNS Therapy System will be the first implantable device-based treatment for depression and the first treatment developed, studied and labeled specifically for patients with treatment-resistant depression.
Vagus nerve stimulation will be the mainstream treatment for chronic or treatment-resistant depression. Over four million American suffer from chronic depression. The final FDA approval will be considered one of the major breakthroughs in medical device history.
Charles Donovan was a patient in the FDA investigational trial of vagus nerve stimulation as a treatment for chronic or recurrent treatment-resistant depression. He was implanted with the vagus nerve stimulator in April of 2001. He chronicles his journey from the grips of depression thanks to vagus nerve stimulation therapy in his book:
Out of the Black Hole: The Patient's Guide to Vagus Nerve Stimulation and Depression
The book will be exhibited at the American Psychiatric Association's Annual Meeting in May.