UPDATE -FDA panel to review studies of Cyberonics device

WASHINGTON, Dec 26 (Reuters) - A U.S. Food and Drug Administration advisory panel next month will review data on the use of Cyberonics Inc.'s (CYBX.O: Quote, Profile , Research) VNS therapy device for depression since its approval, the agency said on Tuesday.

The FDA said the panel will focus on post-approval reports related to the device's controversial use for treatment-resistant chronic or recurrent depression, which was approved by the agency in July 2005.

Shares of the company, which has also become embroiled in an accounting scandal, fell 7.9 percent to $20.83 in afternoon trade on the Nasdaq.

Representatives for the devicemaker could not be immediately reached for comment.

The FDA had no immediate comment.

On Jan. 26 the FDA's Neurological Devices Panel is scheduled to discuss data available since the device's approval. The agency and companies often continue to gather data on a product's safety and effectiveness after it is allowed to be sold.

It was not immediately clear what action, if any, the FDA is considering for VNS, or vagus nerve stimulation, but the agency usually follows the advice of its outside panelists.

Cyberonics' device had already been cleared for epilepsy when the FDA approved it for depression after first asking for more information.

Some consumer advocates criticized the decision, saying there was not enough evidence to prove VNS worked for depression. The approval has also been the target of a Senate Finance Committee investigation.

The FDA posted the announcement on its Web site at http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-21995.htm.

Source

Weren't they supposed to do a few follow up reviews as a condition of the approval? Is this one of those scheduled reviews or something impromptu?