On July 15th, 2005, the U.S. Food and Drug Administration(FDA) approved vagus nerve stimulation "for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older..". This approval concludes the formal seven year study of vagus nerve stimulation and depression.
It is impossible to express the magnitude and importance of this decision that is so important to millions of patients and their loved ones. Vagus nerve stimulation has been FDA approved for pharmaco-resistant epilepsy patients since 1997. Patients suffering from the debilitating illness of chronic depression now have access to the same safe and informatively labeled treatment option.
Many of the subscribers to the VagusNerveStimulator.com Bulletin relentlessly made their voices heard and no doubt contributed to this medical breakthrough decision. I thank you on behalf of the many people who have been waiting for this final and binding decision from the FDA. The manufacturer of the stimulator, Cyberonics, Inc., never gave up its effort to make this remarkable therapy available to those desperate patients who had run out of treatment options.
I will do my best to continue to keep you informed from a patient's perspective who was implanted with the VNS Therapy System in the double-blind, placebo-controlled investigational trial. You will need to continue to strictly follow the medical directives from your psychiatrist. A prescription for VNS Therapy will be required.
I hope that approval of this remarkable procedure gives depression sufferers the hope to continue to seek treatment for their illness. I have walked a mile in their shoes. Any bit of hope can be powerful.
You can learn more about vagus nerve stimulation at www.VagusNerveStimulator.com. There is a free newsletter to keep you up-to-date.
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