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VNS Device For Depression Under Fire - Watchdog Group


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The watchdog group Public Citizen is calling for the FDA to remove approval of the Cyberonics Vagus Nerve Stimulating device recently introduced for treatmenent of refractory depression. The group claims that the company has failed to show that the product is safe and effective as required by FDA regulations. Additionally they are calling on Medicare to deny reimubursement, which is currently under consideration.

Republican Sen. Charles Grassley, chairman of the Senate Finance Committee, reported that a single FDA administrator approved the device against the objections of 20 FDA doctors, scientists and administrators.

The VNS device costs about $25,000.

Of note, Cyberonics is currently facing an SEC probe, and de-listing of its stock from NASDAQ for irregularities in its stock options.


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i was reading one of their BOOKS in the waiting room at the pdoc today. they're at least 30 pages long, telling us these success stories of people who've had this terrible depression that has robbed them of life and now they have come alive thanks to the VNS.

WZ- i'm asking the same thing you are- does anyone actually HAVE this thing, besides the people listed in the propaganda material i read today?

and this was unclear- they indicated it was for depression that has not been helped by drugs. well, isn't that what ect is for? and is this implant good for bipolar disorder? i have a lot of questions about this thing!

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