The U.S. Food and Drug Administration may soon approve a medical device that would be the first new treatment option in the United States for severely depressed patients in a generation, despite the misgivings of many experts who say there is little evidence that it works.
The pacemaker-like device, called a vagus nerve stimulator, is surgically implanted in the upper chest. Its wires are threaded into the neck, where it stimulates a nerve leading to the brain.
It has been approved since 1997 for the treatment of some epilepsy patients, and the drug agency has told the manufacturer that it is now "approvable" for severe depression that is resistant to other treatment. But in the only rigorously controlled trial conducted so far in depressed patients, the stimulator was no more effective than sham surgery.