FDA Approves 3-Minute, Noninvasive Treatment for Depression
The US Food and Drug Administration has approved a 3-minute version of Transcranial Magnetic Stimulation (TMS)—dubbed Theta Burst Stimulation (TBS) or “Express TMS®”—for treatment-resistant major depressive disorder (MDD).
TMS is described by its manufacturer, MagVenture Inc., as “an effective, non-invasive alternative for the large number of patients not responding to medication.” First approved by the FDA in 2008, TMS sessions previously lasted up to 37 minutes, with 20 to 30 total sessions required.
The approval of Express TMS® was granted following the success of the THREE-D trial, which included 414 participants with MDD. The largest double-blinded randomized TMS trial to date, THREE-D demonstrated that 33% of patients treated with TBS protocol achieved response/remission, and 50% experienced an improvement in their depressive symptoms.
These rates were found to be similar to those seen with the standard, longer TMS protocol.
“We are happy and proud to be the first in the US to receive an FDA clearance for this revolutionary treatment which is backed up by substantial scientific evidence,” said Kerry Rome, Vice President of Sales at MagVenture Inc.
“For people needing treatment, this will also be a huge benefit, as treatment will now take up less of their time,” Rome added.
MagVenture, Inc: FDA clears 3-minute, non-pharmaceutical depression treatment [press release]. Atlanta, GA. MagVenture, Inc. August 22, 2018. Accessed on August 23, 2018.