On June 2 at 8:00 pm ET, Reuters news service issued a press release announcing that the FDA have nearly completed final review of the conditions outlined in the February "deemed approvable" letter for VNS Therapy as a treatment for chronic depression. Cyberonics Inc. said that the FDA had nearly completed final review of conditions outlined in the February approval of its implanted device for treatment of chronic depression.
The FDA approved the VNS Therapy System pending final labeling, protocols for a post-marketing dosing study and patient registry, as well as resolution of manufacturing issues and any outstanding clinical trial issues.
The company said a follow-up inspection of its Houston headquarters will begin on Monday. It also said four manuscripts from clinical trials of the device were accepted for publication in "respected psychiatric peer-reviewed journals."
In a statement, Chief Executive Skip Cummins said the company expects to launch sales of the device for "treatment-resistant depression" once minor labeling changes are made and the follow-up inspection has been satisfactorily completed.
Cyberonics also said it has entered a formal quiet period with regard to all public communications pending a final FDA decision or other material information requiring disclosure.
In a statement, Chief Executive Skip Cummins said the company expects to launch sales of the device for "treatment-resistant depression" once minor labeling changes are made and the follow-up inspection has been satisfactorily completed.
Charles Donovan was a patient in the FDA investigational trial for vagus nerve stimulation and depression. After 25 years of chronic depression, vagus nerve stimulation completely cured his chronic depression. The author is so grateful and humbled by this remarkable device. He chronicles is journey in his book Out of The Black Hole: The Patient's Guide to Vagus Nerve Stimulation and Depression
Learn more at his website: http://www.VagusNerveStimulator.com
|
|
|
|
|
|
|
|
|
|
|


A major survey on depression symptoms from the National Mental... Read More
I attended the Vagus Nerve Stimulation Therapy Conference at the... Read More
Depression can have many, many faces. If you are not... Read More
There are several factors can lead to depression after heart... Read More
It is now no secret that people all over the... Read More
On July 18, 2005, the U.S. Food and Drug Administration(FDA)... Read More
Many illnesses, emotional and otherwise, are often said to be... Read More
There are many things that happen within the body when... Read More
Winter time is depression time for many women. Perhaps it... Read More
Everyone feels down or blue once in awhile. Especially during... Read More
According to the World Health Organization, 4 of the 10... Read More
The manufacturer of the vagus nerve stimulator has begun face-to... Read More
Sometimes it's hard to see the forest from the trees.... Read More
Depression is the most prevalent of all the emotional disorders.... Read More
Within the next few weeks, the FDA is expected to... Read More
The Law of PermanenceSuicide is always a permanent solution to... Read More
Typical signs of depression actually show a change in the... Read More
Market surveys on women, men and depression suggest an estimated... Read More
On September 30th 1998 I was crossing the street in... Read More
Depression is something that will occur in many people's lives,... Read More
1. Get out now and walk fifteen minutes. It will... Read More
Katie came as close as is possible to having it... Read More
Being lonely is a normal part of our everyday lives...... Read More
FDA confirms some antidepressants increase suicide risk in some children.... Read More
Looking for a way to reduce the amount of worrying... Read More
I heard about a woman who was suffering from depression,... Read More
"Ring, ring." The crisis operator answers the phone to a... Read More
There is one very simple reason for all emotional depression.In... Read More
My definition of procrastination is that a person delays and... Read More
Andropause correlates directly with depression ? a major player in... Read More
Being lonely is a normal part of our everyday lives.... Read More
Sharon was talking to a friend on the phone one... Read More
World Health Organisation states one out of four worldwide suffer... Read More


Psychological well-being is something that we all have a right... Read More
When most people hear the words American Indian, visions of... Read More
I'm sure at times of deep crisis many of you... Read More
Depression is a serious illness, not a harmless part of... Read More
Market surveys on women, men and depression suggest an estimated... Read More
Do you have days where nothing can make you happy?... Read More
Looking to improve your mood?Edward W. Smith, motivational speaker, author... Read More
Many illnesses, emotional and otherwise, are often said to be... Read More
World Health Organisation states one out of four worldwide suffer... Read More
Chronic Fatigue Syndrome is a... Read More
Andropause correlates directly with depression ? a major player in... Read More
Long term care facilities and residents' doctors should consider combining... Read More
The cover of the March 7, 2005 issue of Business... Read More
Countless number of patients and their family members have asked... Read More
Our innate desire is to be happy, and when we... Read More
Typical signs of depression actually show a change in the... Read More
Depression strikes most of us and it can make us... Read More
The September 1, 2005 issue of Biological Psychiatry confirmed the... Read More
Depression, in psychiatry, is a symptom of mood disorder characterized... Read More
Vagus nerve stimulation is more effective than antidepressants and is... Read More
Looking for a way to reduce the amount of worrying... Read More
It may come in waves, it may control our lives.... Read More
When artiste Leslie Cheung committed suicide, he left behind a... Read More
When a person undertakes a course of therapy through their... Read More
Many people who are suffering from mild to moderate depression,... Read More
A major symposium about vagus nerve stimulation as a treatment... Read More
Cardiologists, other doctors and long term care staff might be... Read More
Being lonely is a normal share of our everyday lives.... Read More
If you've been diagnosed with bipolar disorder (also known as... Read More
1.Remember that it is an illness:Clinical depression often requires medical... Read More
INTRODUCTION Everybody has a story. My... Read More
Schizophrenia suffers around the world have benefitted greatly with the... Read More
If you have been diagnosed with depression or feel that... Read More
Depression |