Danish medical device firm MagVenture has secured approval from the US Food and Drug Administration (FDA) for three-minute non-pharmaceutical depression treatment.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
Established in 2007, MagVenture specializes in non-invasive magnetic stimulation systems for the treatment of major depressive disorder.
The FDA has approved new transcranial magnetic stimulation (TMS) treatment protocol, which will significantly reduce time.
The new treatment form, which is known as theta burst stimulation (TBS), will be completed in three minutes, which is much less time compared to the previous treatment time of 37 minutes per session.
Since 2008, the TMS has been approved by FDA for treatment-resistant major depressive disorder.
The FDA approval for new depression treatment was based on Three-D clinical study, which was carried out at three major Canadian hospitals such as AMH, UHN, and UBC).
The double-blinded and randomized TMS trial assessed 414 participants suffering from major depressive disorder.
According to the company, response/remission rates were 33% for those securing the TBS protocol, whereas 50% had an improvement in their depressive symptoms.
TMS is an effective and non-invasive alternative for most of the patients not responding to medication.
MagVenture TMS therapy delivers magnetic pulses to stimulate nerve cells in the part of the brain that controls the mood.
The rapid change in the magnetic field generates a current. The neurons will be excited, if the current induced is of sufficient amplitude and duration.
MagVenture sales vice president Kerry Rome said: “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.
“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. Our current treatment system, MagVenture TMS Therapy, can easily be 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.”