FDA Clears Intermittent Theta-Burst System for Major Depression

Megan Brooks

April 05, 2019

The US Food and Drug Administration (FDA) has cleared Magstim to include intermittent theta-burst stimulation (iTBS) with its Horizon transcranial magnetic stimulation (TMS) systems, which are used as a treatment for major depression, the company has announced.

"The Horizon system was designed to offer more versatility in one system, and more treatment options for patients. This clearance allows Magstim to market the 3-minute iTBS protocol," the company said in a news release.

Clinicians now have the option of delivering treatments with the standard repetitive TMS (rTMS), which takes 37.5 minutes; accelerated TMS, which takes 19 minutes; and iTBS, which takes only 3 minutes per treatment.

"With efficacy equal to that of standard rTMS, intermittent Theta Burst Stimulation is the newest TMS protocol that maximizes patient throughput," the company said.

They note that customers who already have a Magstim Horizon Performance System do not need to purchase new equipment or upgrade to their system to deliver the iTBS protocol.

Last year, as reported by Medscape Medical News, the FDA approved a 3-minute treatment protocol for the MagVita rTMS therapy system from MagVenture. The company named it "Express TMS." 

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