FDA grants expanded clearance for MagVenture’s depression-treating TMS system

Non-invasive magnetic stimulation developer MagVenture said today it won expanded FDA clearance for its Transcranial Magnetic Stimulation system, now cleared for treatment protocols with shorter treatment sessions.

The Atlanta-based company said a new treatment form using its TMS hardware, dubbed theta burst stimulation, can now be provided in three-minute sessions, down from previous treatment protocols which required up to 37 minutes per session.

The company’s TMS device uses magnetic fields and electric currents to excite and depolarize neurons in the brain and nervous system and is indicated for treating major depressive disorder in patients non-receptive to antidepressant medication, the company said.

MagVita said that it is currently the only company offering the newly cleared, shorter treatment protocol. The company said the system originally won clearance for treating treatment-resistant major depressive disorder in 2008.

Approval for the reduced treatment protocol was supported by data from the company’s 414-patient Three-D clinical trial, which reported response and remission rates of 33% for those using the TBS protocol. A total 50% of patients in the trial reported improvements in depressive symptoms, the company said. Results from the study were published in the journal Lancet.

“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. For people needing treatment, this will also be a huge benefit, as treatment will now take up less of their time,” sales VP Kerry Rome said in a press release.

Last May, MagVenture said that it won FDA clearance for an entry-level version of its MagVita transcranial magnetic stimulation device designed for treating major depressive disorder.

The post FDA grants expanded clearance for MagVenture’s depression-treating TMS system appeared first on MassDevice.

from MassDevice https://ift.tt/2OYoOGn