Studies of depression device to get review

WASHINGTON -- Cyberonics Inc.'s shares fell over 8 percent yesterday after the Food and Drug Administration said the company will update an advisory panel next month on post-marketing studies of its implanted device to treat depression.

The FDA called for the studies as a condition of its July 2005 approval for the additional use of the VNS Therapy device, which was already cleared to treat epilepsy.

Dr. Daniel Schultz, head of FDA's Center for Devices and Radiological Health, said the agency was calling for the Jan. 26 public review in an effort to make sure such post-marketing studies are completed.

"The goal is for them to present an update on whatever they have," he told Reuters.

Shares of Cyberonics, which said last month it will restate its results after uncovering accounting errors, fell 8.1 percent to close at $20.78 on Nasdaq.

Reese Terry, the company's interim chief executive, said the FDA wanted an update on enrollment for a 460-patient clinical trial as well as a 2,000-patient registry.

"They just want to make sure we're on track with the two studies that we agreed to do," Terry said.

Consumer advocates have criticized approval of Cyberonics' stopwatch-size device for treating chronic, treatment-resistant, or recurring, depression, saying there was not enough evidence to prove it worked.

The FDA decision has also been the target of a Senate Finance Committee investigation.

As part of its approval, the FDA ordered the device -- implanted in the chest to send impulses to the brain through a nerve in the neck -- to carry a strong warning cautioning depression patients that VNS therapy is permanent.