It's the first transcranial magnetic stimulation (TMS) device to pass FDA muster. An FDA spokesperson tells WebMD that because the NeuroStar device is not implanted and carries only "moderate" risk, the FDA needed to only "clear" the device and not formally "approve" it.
The clearance comes nearly two years after a January 2007 FDA advisory panel said clinical trials failed to establish that the device was clinically effective. Although TMS-treated patients were twice as likely as sham-treated patients to show clinical benefit, some panel members said this effect was "small," "borderline," "marginal," and "of questionable clinical significance."
Because of these questions about effectiveness, the panel said the device's risk/benefit profile was not comparable to the risk/benefit profile of electroconvulsive therapy (ECT), a highly effective treatment with potentially serious side effects. Although the FDA originally intended to clear the NeuroStar device based on equivalence to ECT, the panel rejected this comparison. The FDA then decided to clear NeuroStar on its own merits.
And TMS truly is different from ECT, says psychiatry professor Michael Thase, MD, chief of the mood and anxiety disorders program at the University of Pennsylvania. Thase has served as a consultant to NeuroStar maker Neuronetics Inc. On the company's behalf, he presented NeuroStar clinical trial data to the 2007 FDA advisory committee.
"TMS is in no way equivalent to ECT in terms of efficacy nor in terms of safety. TMS is less effective but substantially safer than ECT," Thase tells WebMD.
There are important differences between the two treatments:
How well does TMS work? Thase says he's seen meaningful benefit in patients he's treated -- a benefit also seen in clinical trials.
"The track record for TMS in depression is not 100% successful, but studies document a pattern of evidence that this has a significant treatment benefit," he says.
When, if ever, should a patient give TMS a try?
The FDA clearance is for the same patients who did best in clinical studies: people who did not benefit from one antidepressant medication, but who had not yet tried a second antidepressant.
"It fits in between first- and second-choice therapies and ECT," Thase says. "You would not use it in a patient for whom the depression was so disabling that hospitalization was required. And you certainly would not use it for someone who had tried antidepressant treatment of appropriate dosage and duration."
Patients undergoing TMS must be treated four or five times a week for four weeks. Thase says that during this time, his team starts patients on a new antidepressant and weans them from TMS treatment.
News release, Neuronetics Inc.
Michael Thase, MD, professor of psychiatry and chief, mood and anxiety disorders treatment & research program, University of Pennsylvania.
Karen Riley, FDA spokesperson.
FDA, meeting transcript, Medical Devices Advisory Committee, Neurological Devices Panel, Jan. 26, 2007.
FDA, "Brief Summary from the Neurological Devices Panel Meeting -- January 26, 2007.
Neuronetics Panel Presentation, FDA Neurological Devices Panel Meeting, January 26, 2007.
WebMD Medical News: " Device for Depression Criticized."