FDAnews
www.fdanews.com/articles/90737-fda-panel-dampens-neuronetics-hopes-for-approval-of-depression-device

FDA PANEL DAMPENS NEURONETICS' HOPES FOR APPROVAL OF DEPRESSION DEVICE

February 6, 2007

An FDA advisory panel was unable to give its vote of confidence to a new device meant to treat severe depression last month. This leaves Cyberonics' vagus nerve stimulation therapy to dominate the U.S. market for emerging alternative treatments to currently accepted electroconvulsive therapy (ECT), an analyst says.

The Neurological Devices Panel met Jan. 26 to assess a premarket notification, or 510(k), application for Neuronetics' NeuroStar, a repetitive transcranial magnetic stimulation device. Panelists were charged with assessing the device's safety, effectiveness and balance of risks to benefits to determine its "substantial equivalence" to ECT.

"A finding of substantial equivalence does not require equal risk and equal benefit," the FDA noted. "This means the device can be safer but less effective or alternatively less safe but more effective than the predicate device."

The FDA panelists agreed that, while the NeuroStar might be safer than ECT, existing clinical trial data fell just short of achieving the .05 percent threshold that would have been adequate to show improvement. Several panelists indicated that the data presented pointed only to a "signal" of effectiveness.

(http://www.fdanews.com/ddl/34_6/)