FDA Clears 3-Minute Brain Stimulation Protocol for Depression

Megan Brooks

August 22, 2018

The US Food and Drug Administration (FDA) has approved a newer and faster treatment protocol for the MagVita repetitive transcranial magnetic stimulation (rTMS) therapy system from MagVenture, the company has announced.

The FDA first cleared the MagVitaTMS therapy system in 2015 for treatment of adults with drug-resistant major depressive disorder, as reported by Medscape Medical News.

Until now, each treatment session has lasted up to 37 minutes, with 20 to 30 sessions needed in total. With the new treatment protocol, which uses intermittent theta-burst stimulation (iTBS), a treatment session lasts only 3 minutes, the company said in a news release.

The newly approved iTBS protocol is based on results of a multicenter, noninferiority clinical trial involving 414 adults with treatment-resistant major depression who were randomly allocated to receive standard rTMS or iTBS.

The iTBS protocol was shown to be noninferior to rTMS, according to a report published in the Lancet earlier this year.

For both treatments, the number of dropouts was low, and side-effect, safety, and tolerability profiles were similar. With iTBS, the number of patients treated per day with current rTMS devices can be increased several times without compromising clinical effectiveness, the authors concluded.

"We have named it 'Express TMS' because that's what it is: a treatment which is just as safe and effective for the treatment of depression as conventional TMS, only much, much faster," Kerry Rome, MagVenture's vice president of sales, said in the release.

Rome said the current MagVenture TMS therapy system can be easily upgraded with the new Express TMS option. "This will enable our many customers to treat far more patients per day without having to invest in another TMS device. For people needing treatment, this will also be a huge benefit, as treatment will now take up less of their time," said Rome.

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