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  FDA Nears Completion of Review of Vagus Nerve Stimulation For Chronic Depression

Get Rid Of Depression!
Depression - How To Heal Your Depression Audio.

Author: Charles Donovan

Article source: http://www.askcolman.com/. Used with author's permission.

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




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No charges for webcam suicide audience 29 May 2007 18:16, Yahoo News
... the suicide of Kevin Whitrick, 42, from Wellington, Shropshire. Mr Whitrick had suffered from depression following a serious car accident which he had not recovered from. In a statement, ...

People in the greatest need of cardiac medications and interventions are less likely than moderately ill patients to get the full range of heart drugs and procedures, a pair of cardiologists suggests. ... in Edmonton. He wasreferring to patients whose functional capacity is limited or who have depression. The second study looked at rates of catheterization of heart patients over two periods ...



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