Magstim Horizon Inspire and 3.0 Transcranial Magnetic Stimulation Systems have received FDA clearance for the treatment of major depressive disorder (MDD) in adolescent patients, ages 15-21. Announced in March, the approval adds to other recent certifications for the company’s systems and to growing acceptance worldwide for the effectiveness of TMS technology in helping patients who are battling depression.
Late last year, Magstim was awarded other clearances in both the UK and USA for its Inspire system. Previously, it received approvals of its systems for the treatment of major depressive disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from obsessive-compulsive disorder (OCD).
On May 16, Magstim announced that it has been granted EU MDR Certification for all its transcranial magnetic stimulation (TMS) systems, demonstrating compliance with strict European Union Medical Device Regulations. This provides a path for Magstim TMS technology to be sold throughout the EU. It also recently has been awarded UKCA clearance for the Inspire system, opening the door for greater use in the UK’s NHS. UKCA is Britain’s version of the CE mark, established since its withdrawal from the European Union.
“Physicians, nurse practitioners and mental health care professionals tell us that patients are searching for alternatives to pharmaceutical treatments,” said Ronnie Stolec-Campo, CEO. “FDA cleared transcranial magnetic stimulation 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.”
According to Stolec-Campo, professionals requested a system to quickly launch their TMS practices. The Inspire addresses their needs with high-power air-cooling, ability to deliver back-to-back customizable treatments, all while being easy to use, cost-effective and offering portability between clinic rooms. It is built on Magstim TMS technology which now has been cited in more than 20,000 peer reviewed research papers and used in hospitals, clinics and research centers worldwide.
The use of TMS for treating MDD and OCD is increasing worldwide, driven by new studies demonstrating its effectiveness over other treatments, says the company. TMS is now covered by most insurance companies in the USA including Medicare. Many states now permit both physicians and psychiatric nurse practitioners to prescribe and treat patients with TMS.
The Inspire system leverages intuitive preset clinical workflows to simplify the treatment process, delivering precise results with no pulse decay, ensuring the correct dosage. An air-cooled coil reduces downtime and eliminates additional cooling expenses, while advanced data analytics tools improve treatment efficacy.
“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.”
Most of Magstim’s operations are located in Spring Gardens, Whitland in southwest Wales. It is one of four brands of the Welcony group of neurotechnology companies. For more info, see www.magstim.com and www.welcony.com.
