MagVenture TMS Therapy System

The MagVenture TMS Therapy System is a transcranial magnetic stimulation device that delivers non-invasive magnetic pulses to induce electrical currents in the brain, targeting the prefrontal cortex. It is indicated for treating depressive episodes and comorbid anxiety symptoms in adults with Major Depressive Disorder who have failed prior antidepressant medication, and as an adjunct for Obsessive-Compulsive Disorder treatment.

The device uses figure-of-eight electromagnetic coils with dual windings and an air core (versus predicate's ferromagnetic core), biphasic pulse delivery at 290 microseconds pulse width (versus predicate's 185 microseconds), and forced liquid cooling to a maximum coil temperature of 43°C (versus predicate's 44°C air cooling). Treatment parameters—120% motor threshold intensity, 10 Hz repetition rate, 4-second train duration, 3000 pulses per session—are identical to the predicate.

IEC 60601-1 (general safety and essential performance), IEC 60601-1-2 (electromagnetic compatibility), IEC TR 60601-4-2 (electromagnetic immunity), ISO 13485:2016 (quality management), and ISO 14971:2019 (risk management). Computational modeling using SimNIBS v4.0.1 was used to compare electric field strength of MagVenture coils against the predicate device.

Both devices target identical brain regions using the same principles of operation—repetitive magnetic pulse trains at the same clinical parameters (e.g., 120% MT, 10 Hz for MDD). Minor technical differences in coil core design, cooling method, and pulse width do not raise different safety or effectiveness questions because both cooling approaches maintain equivalent maximum temperatures, and computational modeling confirms comparable electric field delivery. The Beam F3 marking plate provides an alternative, validated method for coil positioning functionally equivalent to the standard 5.5 cm method, and prior clearances (K150641, K171481) already established substantial equivalence for identical intended uses.