Newly FDA-Cleared TMS for Major Depressive Disorder, Obsessive-Compulsive Disorder, and Anxious Depression

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Magstim just announced that the US Food and Drug Administration (FDA) has granted clearance to its Horizon Inspire transcranial magnetic stimulation (TMS) system to treat major depressive disorder (MDD), obsessive-compulsive disorder (OCD), and anxious depression.¹

“Physicians, nurse practitioners, and mental health care professionals tell us that patients are searching for alternatives to pharmaceutical treatments,” said Ronnie Stolec-Campo, the CEO of Magstim. “FDA-cleared TMS is a proven and effective treatment with minimal side effects. We designed the Inspire to enable both experienced TMS providers as well as those who are new to TMS.”

The use of TMS for treating MDD and OCD is increasing, driven by new studies demonstrating its effectiveness over other treatments. One-third of patients with MDD experience inadequate response to pharmacotherapy and psychotherapy. After 2 failed antidepressant trials, a different therapeutic modality might be beneficial, including TMS.²

The Inspire system allows clinicians to provide easy to use, cost effective, portable, high-power, air-cooling, back-to-back customizable TMS treatments. The Inspire system is built using Magstim TMS technology, which is cited in more than 20,000 peer reviewed research papers. It is used in hospitals, clinics, and research centers worldwide. The system also leverages intuitive preset clinical workflows to simplify the treatment process, and delivers precise results with no pulse decay, ensuring the correct dosage. Magstim’s air-cooled coil reduces downtime and eliminates additional cooling expenses. Furthermore, its advanced data analytics tools improve the efficacy of the treatment.

TMS is now mostly covered by insurance, including Medicare. Additionally, the range of clinicians available to utilize TMS has expanded: many states now permit both psychiatrists and psychiatric nurse practitioners to prescribe and treat patients with TMS.

Earlier this year, the FDA granted clearance to Magstim’s TMS technology, Horizon 3.0 with StimGuide Pro, which is indicated for adults with MDD who failed to achieve improvement from prior antidepressant trials, and for adults with OCD. Horizon 3.0 with StimGuide Pro is the first integrated TMS system with navigation, adding new advanced camera technology designed to allow for precise treatment targeting and a central screen intended to reduce complexity. The Horizon 3.0 TMS Therapy System has also received prior clearance for decreasing comorbid anxiety symptoms in adults with MDD.³

“We are passionate about helping patients worldwide to improve their mental health,” said Stolec-Campo. “We worked with leading psychiatrists, clinicians, and researchers to develop this system, enabling advanced treatments and simplified practice workflows. TMS is life-saving technology that provides nonpharmacological, noninvasive treatments.”³

A psychiatric provider, Khaled Bowarshi, MD, also shared this about Magstim’s products: “Our TMS patients have experienced a high-degree of success, allowing them to change their lives. We strive to provide the best technology for our patients.”³

“Magstim engineered the very first commercially available TMS research technology, and we remain committed to our foundation of research,” said Stolec-Campo. “We are unique in the industry because we do not charge pay per use fees, we maintain a dedicated service and support team, and we manufacture our own technology.”¹

References

1. FDA clears Magstim Horizon INSPIRE transcranial magnetic stimulation system to treat depression, OCD, anxious depression. News release. November 12, 2024. https://finance.yahoo.com/news/fda-clears-magstim-horizon-inspire-131100376.html

2. Miller B. rTMS for Antidepressant Nonresponders. Psychiatric Times. October 21, 2024. https://www.psychiatrictimes.com/view/rtms-for-antidepressant-nonresponders

3. Kuntz L. First integrated TMS system for major depressive disorder, obsessive-compulsive disorder. Psychiatric Times. January 30, 2024. https://www.psychiatrictimes.com/view/first-integrated-tms-system-for-major-depressive-disorder-obsessive-compulsive-disorder