FDA Grants NeuroStar® Advanced Therapy System Breakthrough Device Designation to Treat Bipolar Depression
The FDA’s Breakthrough Device Program is intended to help patients and healthcare providers receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program creates an expedited pathway for prioritized FDA review of the NeuroStar Advanced Therapy clinical trial program.
“We are delighted that the FDA has accepted our application for Breakthrough Device Designation and look forward to working closely with them to provide a potential solution for people with bipolar depression. This potential new treatment indication for NeuroStar means that millions of people with bipolar disorder who do not respond to medications may have a proven, non-drug treatment available to them,” said
Bipolar I and II disorder cause recurrent, dramatic shifts in mood, energy, and activity levels. Bipolar disorder affects approximately 6.5-7 million
In 2008, NeuroStar Advanced Therapy was the first TMS device to receive FDA clearance for adults with Major Depressive Disorder who have not seen success with at least one antidepressant medication. NeuroStar is a non-invasive form of neuromodulation that uses magnetic pulses to stimulate areas of the brain that are underactive in depression.3, It is now the first TMS device to receive Breakthrough Device Designation for bipolar depression in adult patients with Bipolar I or Bipolar II disorders that have failed to receive satisfactory improvement from prior pharmacological therapy.
About NeuroStar® Advanced Therapy
NeuroStar® Advanced Therapy is the market leader in transcranial magnetic stimulation (TMS), a non-invasive form of neuromodulation, and the #1 TMS choice of doctors for patients with Major Depressive Disorder (MDD). Widely available across
In an NIMH-funded, independent, randomized controlled trial, patients treated with TMS using a clinical-trial version of the NeuroStar TMS System were 4.2 times more likely to achieve remission compared to patients receiving sham treatment (P = 0.02; odds ratio = 4.05).5 The most common side effect is pain or discomfort at or near the treatment site, which usually resolves within one week. It is contraindicated in people with non-removable conductive metal in or near the head.
NeuroStar® is a registered trademark of
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1https://biomedtracker.com/indicationreport.cfm?indid=168 (Pharma Intelligence BioMed Tracker) based on
3 Post A, et al.
4 Liston C, et al. Biol Psychiatry, (2014)