FDA Okays TMS Device for Rapid Treatment of Major Depression

Megan Brooks

April 18, 2017

The US Food and Drug Administration (FDA) has cleared the next-generation NeuroStar Advanced Therapy transcranial magnetic stimulation (TMS) device for patients with treatment-resistant major depressive disorder (MDD), the company has announced.

The NeuroStar TMS system was first approved by the FDA in 2008 for drug-resistant MDD.

The Malvern, Pennsylvania–based company said the advanced system is the only FDA-cleared TMS treatment that can be delivered in less than 19 minutes, although treatment time may vary, depending on the physician's recommendation.

NeuroStar Advanced Therapy is a nondrug treatment for MDD that "changes the game for those patients who have seen failures with prescription medicine," Kenneth Pages, MD, medical director, TMS of South Tampa, Florida, said in a company news release.

"And now, the 19-minute treatment takes the next big step forward in improving patient access to this therapy. With NeuroStar Advanced Therapy, I have confidence and comfort as I treat my patients because I know it allows for the right treatment dose to be delivered to the right location every time, giving my patients the best possible chance for long-term remission," Dr Pages said.

"We have widespread insurance reimbursement from most commercial and government health plans, and a next-generation NeuroStar Advanced Therapy that uses proprietary technology and a 19-minute treatment that allows patients to get in and out before work or during their lunch hour," NeuroStar President and CEO Chris Thatcher said in the release.

The NeuroStar Advanced Therapy TMS device includes a high-performance coil, 3D laser positioning, and contact sensing and provides real-time feedback to the physician to help deliver more consistent, reliable treatment, NeuroStar said.

Research has shown that TMS can provide lasting relief of antidepressant-resistant MDD and improved quality of life for patients.

An economic analysis of the NeuroStar TMS system showed that it is a cost-effective treatment option in comparison with drug therapy.

In an independent, randomized controlled trial funded by the National Institute of Mental Health that was published in Archives of General Psychiatry in 2010, patients treated with TMS using a clinical-trial version of the NeuroStar TMS System were 4.2 times more likely to achieve remission compared to patients receiving sham treatment (P = .0173; odds ratio = 4.05).

The most common side effect with the device is pain or discomfort at or near the treatment site, which usually resolves within 1 week, NeuroStar said. It is contraindicated in people with nonremovable conductive metal in or near the head. Long-term durability of effect has not been established in a randomized controlled trial.

Last November, as reported by Medscape Medical News, NeuroStar launched a registry for patients with depression who underwent treatment with TMS therapy to gather data on real-world efficacy. The registry intends to collect and analyze data from more than 6000 patients with MDD who have been treated with NeuroStar Advanced Therapy.

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