NeuroStar said today it won FDA clearance for its next-gen NeuroStar advanced therapy transcranial magnetic stimulation device.
The Malvern, Penn.-based company touted the device, which is designed to treat individuals with major depressive disorder, as the only FDA cleared TMS treatment which can be delivered in under 19 minutes.
“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. 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. 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,” Dr. Kenneth Pages of Florida’s TMS of South Tampa said in a prepared statement.
The newly cleared, next-gen device includes a high performance coil, 3D laser positioning and contact sensing and provides real-time feedback to the operating physician to help deliver more consistent, reliable treatment, NeuroStar said.
“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. 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,” prez & CEO Chris Thatcher said in a press release.
NeuroStar 1st won FDA clearance for it Advanced Therapy device in 2008, with indications for treating Major Depressive Disorder in patients who have not seen success with at least 1 antidepressant, the company said.
Last November, NeuroStar said it launched a real-world registry for patients with depression treated with TMS therapy, touting it as the largest registry of its kind to date.
The registry looks to collect and analyze data from over 6,000 patients with major depressive disorder who have been treated with NeuroStar Advanced Therapy to better understand outcomes and usefulness of the therapy in a clinical setting.