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Cyberonics Stumbles and ANS Lends a Hand

An unexpected and unfavorable ruling from the FDA has left Cyberonics officials angry and frustrated and has put in jeopardy the depression opportunity the company was counting on. Also on Cyberonics' plate: an unwelcome merger bid from rival neurostimulation company, ANS.

It's not often that medical technology companies develop a device with the potential of a pharmaceutical blockbuster. But for much of the last couple of years, that's precisely what executives at Houston-based Cyberonics Inc. felt confident they had, with an expansion of their vagus-nerve stimulation (VNS) technology, currently used in epilepsy, into the field of depression. (See "Cyberonics and Depression's Happy Face," IN VIVO, November 2003 Also see "Cyberonics and Depression's Happy Face" - In Vivo, 1 November, 2003..) Indeed, Cyberonics officials last year predicted that the depression application of their technology alone could account for more than $300 million in annual in sales within three years and $1 billion by ten years post-launch.

But those plans were dealt a serious setback this month when the FDA refused to follow a panel recommendation to...

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