FDA Clears 3-Minute TMS as Refractory Depression Treatment
MagVenture Inc., a provider of transcranial magnetic stimulation (TMS), has received clearance from the US Food and Drug Administration (FDA) for a new protocol that cuts the time of each treatment session down to 3 minutes, the company announced.
The new treatment form, theta burst stimulation (TBS), is indicated for the treatment of major depressive disorder in adults who have not received satisfactory improvement from antidepressant medications in the current depressive episode.
Currently, each session of TMS can last up to 37 minutes, with a treatment course requiring 20 to 30 sessions.
“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,” said Kerry Rome, vice president of sales for MagVenture.
“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.”
In a double-blind, randomized clinical trial of TBS, led by three research hospitals in Canada, 32% of the 414 participants with MDD experienced response or remission, while 49% had an improvement in their depressive symptoms. Those rates are similar to the results seen with standard TMS, according to MagVenture.
Providers who currently offer MagVenture TMS Therapy upgrade to the new system, which is currently offered only by MagVenture.
Blumberger DM, Vila-Rodriguez F, Thorpe KE, et al. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. The Lancet. 2018;391(10131):1683-1692.