FDA Clears Theta Burst Stimulation Device for Major Depression

APRIL 05, 2019
Kevin Kunzmann
FDAThe US Food and Drug Administration (FDA) has cleared the Horizon Transcranial Magnetic Stimulation (TMS) Therapy systems to provide treatment to patients with major depressive disorder (MDD) via its intermittent Theta Burst Stimulation (iTBS) procedure.

The clearance, granted to Magstim, adds another marketed treatment option to the company’s versatile TMS system. The iTBS protocol is designed to provide three-minute treatment to patients with MDD, complementing the company’s current repetitive TMS (rTMS) option of 37.5 minutes and accelerated TMS option of 19 minutes.

The device uses focused electromagnetic coil to pulse a magnetic field in rapid fashion to targeted areas of the brain. The small electrical current generated stimulates targeted brain cells into activity, and gradually increases brain activity back to a normal level.

Theta burst therapy, which investigators noted is gaining popularity particularly in TMC centers based in the UK, is currently being assessed for its efficacy in relation to standard TMS for patients with depression. The BRIGHTMIND study is currently undergoing recruitment to compare rTMS versus navigated iTBS in patients with depression.

With the FDA indication, Magstim can now market the “full capabilities” of the Horizon platform, chief executive officer Lothar Krinke said.

“The versatility coupled with the proprietary Energy Recovery System gives us a distinct advantage in the market,” Krinke said in a statement. “We want to provide innovative systems that allow clinicians and researchers to customize and personalize treatment for patients, and this clearance is another step in that direction.”

Just last August, the FDA had approved a competing three-minute TMS device from MagVenture. At the time of the approval of the company’s Express TMS device for patients with MDD, it was considered a novel therapy on the US market.

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