Magstim’s Horizon system was designed to offer versatility in transcranial magnetic stimulation. (Image from Magstim)
Magstim has received FDA clearance to include intermittent Theta Burst Stimulation (iTBS) as a treatment for major depressive disorder with its Horizon transcranial magnetic stimulation (TMS) therapy systems.
This clearance allows Magstim to market the 3-minute iTBS protocol in addition to the previously cleared standard repetitive transcranial magnetic stimulation (rTMS), which takes 37.5 minutes, and accelerated TMS (19 minutes), according to the Eden Prairie, Minn.-based company.
In depressed patients, electrical activity in certain areas of the brain is reduced. The Horizon Performance device uses a focused electromagnetic coil to rapidly pulse a magnetic field to the targeted area of the brain. This induces a small electrical current which stimulates the targeted brain cells into activity, gradually increasing brain activity back to a normal level.
Horizon was designed to offer versatility in one system and treatment options for patients, using the company’s proprietary energy recovery system for consistent dosage throughout the treatment with no pulse amplitude decay. Customers who already have a Magstim Horizon system will not need to purchase new equipment or upgrade to their system to deliver the iTBS protocol. The E-z Cool Coil, included in the Horizon performance package, has been specifically designed for iTBS while still providing the option for standard rTMS protocols, according to the company.
“I am pleased that we can now market the full capabilities of the Horizon Performance platform,” said Magstim CEO Lothar Krinke in a prepared 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.”
iTBS is already available in the U.K. and E.U. A multi-center National Institute for Health Research-funded clinical trial designed to evaluate standard rTMS versus navigated iTBS in depression recently began recruiting patients in the U.K.
“Theta burst therapy is rapidly gaining popularity among TMS Centers in the U.K.,” said Dr. Alex O’Neill-Kerr, the clinical lead for The Centre for Neuromodulation at Berrywood Hospital in Northampton, U.K. “Based on evidence from elsewhere in the world, it is as effective as standard TMS. In the NHS, having the option of theta burst allows us to tailor the best treatment protocol for the patient.”
