Transcranial magnetic stimulation therapy cleared by FDA

18th April 2017
Posted By : Enaie Azambuja
Transcranial magnetic stimulation therapy cleared by FDA

NeuroStar Advanced Therapy is now the only FDA-cleared TMS treatment in the United States delivered in under 19 minutes. The next generation NeuroStar system is designed to benefit both physicians and patients, with increased convenience and scheduling flexibility for patients who need to fit daily treatment into their busy lives, and doctors looking to provide therapy to a growing patient population.

"NeuroStar Advanced Therapy is a proven breakthrough treatment that has helped more than 50,000 people find relief from their depression, but many people still have not heard of it. That's because up until now patients struggled with insurance reimbursement and treatment scheduling challenges," said Chris Thatcher, President and CEO of Neuronetics.

"Today, the most significant barriers to NeuroStar treatment are now gone. We have wide-spread insurance reimbursement from most commercial and government health plans, and a next generation NeuroStar Advanced Therapy that uses proprietary technology and a 19-minute treatment that allows patients to get in and out before work or during their lunch hour."

Approximately four and a half million people in the United States being treated for depression do not benefit from antidepressant medication. With more than one million treatments delivered to date, NeuroStar Advanced Therapy was cleared by the FDA in 2008 as a safe and effective treatment for adult patients with Major Depressive Disorder (MDD) who have not seen success with at least one antidepressant.

It is available by prescription and typically administered daily in a doctor's office for four to six weeks. The non-drug, non-invasive treatment uses magnetic pulses to stimulate areas of the brain that are underactive in depression. It is not electroconvulsive therapy (ECT) and uses a different mechanism than ECT.

Backed with the most clinical studies for TMS in depression, NeuroStar therapy is free from side effects often associated with antidepressants. The majority of people who benefited from treatment with NeuroStar experienced clinically meaningful, long-lasting improvement; NeuroStar had proven durability over 12 months in an open-label clinical trial.

Additionally, over the past year, there has been approximately a 20% increase in the number of NeuroStar systems across the country — further increasing patient access to this transformative treatment.

"As a practicing psychiatrist, I see firsthand the incredible struggle that my patients have while trying to find the right treatment for MDD. STAR*D was the first federally funded, large-scale, long-term study that compared treatment strategies for depression patients. It showed that patients with one prior treatment failure have only a 21% chance of achieving remission, and that chance goes down to 7% with three prior treatment failures," Kenneth P. Pages, M.D., Medical Director, TMS of South Tampa stated.

"NeuroStar Advanced Therapy is truly a breakthrough, non-drug treatment for MDD that changes the game for those patients who have seen failures with prescription medicine. And now, the 19-minute treatment takes the next big step forward in improving patient access to this therapy."

The new NeuroStar Advanced Therapy offers several unique and innovative capabilities compared to generic TMS devices, including a High Performance Coil, 3D Laser Positioning, and Contact Sensing.

These sophisticated technology features provide physicians with real-time feedback and deliver reliable and consistent treatment. NeuroStar shows proven efficacy across a broad range of treatment resistance. In an open-label clinical trial, 58% of patients significantly responded to treatment, and 37% achieved complete remission of their depression symptoms.

Kenneth P. Pages, M.D. added, "With NeuroStar Advanced Therapy, I have confidence and comfort as I treat my patients because I know it allows for the right treatment dose to be delivered to the right location every time, giving my patients the best possible chance for long-term remission."

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