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. ("Skip") Cummins, Cyberonics' Chairman of the Board and Chief Executive Officer commented: "This major step forward towards the accomplishment of Cyberonics' 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."
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.
You can learn more at http://www.VagusNerveStimulator.com. There is a free electronic 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
The book will be exhibited at the American Psychiatric Association's Annual Meeting in May.
He is editor the http://www.VagusNerveStimulator.com Web Site
Long term care facilities and residents' doctors should consider combining... Read More
Maria has been increasingly depressed for the past few years.... Read More
Life wasn't easy for cave men. They had to hunt... Read More
The September 1, 2005 issue of Biological Psychiatry confirmed the... Read More
Final FDA approval of vagus nerve stimulation as a therapy... Read More
It seems unreal, another major storm hitting Florida after experiencing... Read More
According to the June 7th issue of the Wall Street... Read More
Since Dr Malcolm Peet, a consultant psychiatrist at Sheffield swallow... Read More
Many illnesses, emotional and otherwise, are often said to be... Read More
We all have blue days:We're missing someone we've lost, the... Read More
"Thanks for Noticin' Me" says Eeyore. He walks slowly. He... Read More
My definition of procrastination is that a person delays and... Read More
A new research study has again shown that a diet... Read More
As a counselor, I am often asked, "Can drugs be... Read More
Being lonely is a normal part of our everyday lives.... Read More
1.Remember that it is an illness:Clinical depression often requires medical... Read More
While it may be easy to recite the various brand... Read More
THE RISKAccumulation of acids in your body, due to insufficient... Read More
Vagus Nerve Stimulation for Chronic Treatment-Resistant Depression About Vagus Nerve... Read More
What do you do when your fears and depression are... Read More
I'm sure at times of deep crisis many of you... Read More
The Law of PermanenceSuicide is always a permanent solution to... Read More
No doubt you have seen the recent news headlines about... Read More
With the next few weeks, the FDA is expected to... Read More
Millions of people sufferaround the world from a depressive illness.... Read More
On February 3, 2005 the U.S. Food and Drug Administration... Read More
Do you blame your past, your family, your partner, your... Read More
In 1965, a chemist working to develop an ulcer drug... Read More
Our innate desire is to be happy, and when we... Read More
I felt cold, my body was stiff and my back... Read More
Neurotransmitters (NTs) are essential chemical messengers that regulate brain, muscle,... Read More
There is an illness all around me in modern society... Read More
Market surveys on women, men and depression suggest an estimated... Read More
There is one very simple reason for all emotional depression.In... Read More
FDA confirms some antidepressants increase suicide risk in some children.... Read More
For those who face depression, every day of their lives... Read More
It is now no secret that people all over the... Read More
If you have been diagnosed with depression or feel that... Read More
The 'experts' have tried to evaluate me as a sufferer... Read More
Depression is the most prevalent of all the emotional disorders.... Read More
According to the World Health Organization, 4 of the 10... Read More
Only somebody who has lived with anxiety ? as either... Read More
It may come in waves, it may control our lives.... Read More
We've all been there? One minute your listening intently as... Read More
It is true that forms of depression cannot be avoided,... Read More
Do you have days where nothing can make you happy?... Read More
When we have depression, one of the things we drop... Read More
On September 1st, the efficacy and safety of vagus nerve... Read More
INTRODUCTION Everybody has a story. My... Read More
With the next few weeks, the FDA is expected to... Read More
Depression Depression |