Neuronetics (Malvern, PA) received the European CE Mark to bring its NeuroStar transcranial magnetic stimulation (TMS) system across the pond. It has been approved for use in the U.S. for about for years now.
Only two days ago we published our interview with Dr. Mark Demitrack, Chief Medical Officer of Neuronetics, during which we talked about the NeuroStar system and a recent study evaluating its use for people with unipolar, non-psychotic Major Depressive Disorder (MDD).
From the announcement of the regulatory clearance:
The decision is based on data from five studies, collectively representing the largest clinical data set for a therapeutic use of TMS, that demonstrate the safety and efficacy of NeuroStar TMS Therapy in depressed patients across a broad range of antidepressant treatment resistance. One of the five studies has shown a sustained benefit through six months of follow-up in a majority of patients, with only eleven percent of patients experiencing a relapse of illness.
Recent studies conducted using the NeuroStar TMS Therapy System, include a published, National Institute of Mental Health funded, and company-independent research study evaluating NeuroStar TMS Therapy in patients with major depression (George, et al 2010). This study replicated and extended the results reported in Neuronetics’ multicenter, controlled trial and further validated TMS Therapy as an effective and safe treatment option without the systemic side effects of drug treatment.
In the recent Treatment Utilization and Outcomes Study conducted by Neuronetics, one out of two patients responded to NeuroStar TMS Therapy, defined as experiencing a decrease in symptoms by at least 50 percent. One out of three patients achieved remission, defined as experiencing the absence of any clinically meaningful illness symptoms. These results replicate the results of two prior open-label clinical trials of NeuroStar TMS Therapy and verify that these outcomes are achieved with the NeuroStar TMS Therapy System during general clinical practice (Neuronetics data on file, 2012).
Since its U.S. FDA clearance in 2008, NeuroStar TMS Therapy has been administered to over 8,000 patients through more than 250,000 treatments at 400 centers in the U.S.
Press release: Neuronetics, Inc. Receives CE Mark Approval for NeuroStar TMS Therapy…
Product page: NeuroStar TMS Therapy System…
Flashbacks: The Promise of TMS: Interview with Neuronetics Chief Medical Officer Mark Demitrack, M.D.; Neuronetics TMS Depression Therapy Gets FDA OK
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