Apollo TMS Therapy System

The Apollo TMS Therapy System is a non-invasive electromagnetic device that delivers rapidly pulsed magnetic fields to the brain to stimulate neurons. It is indicated for treating Major Depressive Disorder in adults who have failed antidepressant medication, and as an adjunct treatment for Obsessive-Compulsive Disorder in adults. The system consists of a user interface running "Stimware" software, a main unit, stimulation coil, and coil positioning system.

The Apollo system uses figure-of-eight biphasic coils with an E-field output of 130 V/m at 1.0 SMT, identical to the predicate HORIZON 3.0. Key differences include pulse width (Apollo: 162–163 µs for pCool/aCool coils versus HORIZON: 330–340 µs) and frequency range (Apollo: 1–100 Hz ±2% versus HORIZON: 1–20 Hz). Both deliver OCD treatment to the dorsomedial prefrontal cortex using identical parameters: 100% leg motor threshold, 20 Hz, 2-second trains, 50 trains per session, 5 days per week for 5 weeks plus 4 days. Both maintain surface temperatures within recognized safety limits.

ISO 10993-1 (biocompatibility), IEC 60601-1 (electrical safety and essential performance), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-1-6 (usability), IEC 62304 (software lifecycle), ISO 14971 (risk management), ISO 15223 (medical device labeling symbols), and IEC 81001-5-1 (health IT systems security).

The Apollo system delivers identical OCD treatment protocols to the HORIZON 3.0 predicate—same stimulation intensity (100% leg motor threshold), frequency (20 Hz), pulse train duration (2 sec), inter-train interval (20 sec), trains per session (50), and treatment schedule (5 daily sessions for 5 weeks). Verification testing confirmed equal and constant stimulus intensity throughout full OCD treatment delivery. Although pulse width and frequency range differ slightly, the output stimulation characteristics are adequately similar, and non-clinical performance testing shows no new hazards or safety risks. The device passed the same recognized international standards (IEC 60601-1) and test protocols already used in prior clearances. Clinical data was not required because the indications, target population, treatment procedure, and brain stimulation site are identical to the predicate.