The Term "FDA Approved and FDA Approved Devices":
FDA approval basically says how a medicine, or in this case a medical device treatment, can be marketed. The FDA does not control how a device can be used. When a medication or medical device is in the process of obtaining FDA approval, they are trying to show it is both safe and effective in treatment. To do so they pick an area of treatment, such as depression, where they desire to get approval. All of their research is then aimed at that one condition and when it is approved for treating a particular condition, that is called an indication. For example, TMS has the indication for treating depression. What an indication does not mean is that TMS is ineffective in treating other conditions, nor is it inappropriate to treat other conditions using TMS.
Physicians use medications and medical devices in treating conditions they believe have enough research behind them to warrant the treatment. It is often said that publication is two years behind the research. This means by the time it takes to do the study and have it published in a journal, most physicians in the specialty are aware of its efficacy and are already using it to treat that condition.
FDA clearance of the NeuroStar TMS Therapy® System was largely based on results of a registration clinical trial program that included the largest multicenter, randomized, controlled trial of TMS in major depression.1,2
A second, similarly designed National Institute of Mental Health (NIMH) sponsored randomized study was published in 2010, and provided additional evidence of TMS efficacy using the clinically significant outcome of remission.3 Other recent studies include an open-label follow on study that replicated the results of Neuronetics’ open-label extension study3, and Neuronetics’ 6-month study of TMS safety and durability.4
Ongoing Clinical Trials
The provider of the device we use, Neuronetics, continues to support clinical trial programs. The following are sponsored by Neuronetics:
- Postpartum study –TMS Therapy is already approved for Major Depressive Disorder. This study will focus on understanding the response in women suffering from postpartum depression. This study is currently enrolling patients who are:
- Female 18 to 50
- Diagnosed with major depression within 6 months of childbirth
Depression is a serious illness, affecting approximately 16.1 million people in the U.S, and 350 million people worldwide. Depression is a "life stealer”, it grays over and weights down joy and vitality, and is becoming the largest health burden in world health. For years, medication has helped manage symptoms, however, many patients are just not satisfied with the results, nor the nasty side effects they get with the “cocktail” of standard drug based therapy. There is hope…
TMS Therapy, “Transcranial Magnetic Stimulation” (TMS) is about giving lives back. TMS Solutions utilizes patented, FDA cleared, NeuroStar TMS Therapy® to provide a proven, successful approach to achieving remission from depression (not just manage symptoms!). Many insurance companies, including Medicare and Blue Cross (in most states), and now Humana and the VA are now covering and allowing this process. In addition to treating depression, it is also proving helpful in treating anxiety, PTSD, Tinnitus and Postpartum depression.
- TMS efficacy is showing better results than traditional medication, with far fewer, less severe side effects.
- TMS Therapy has provided relief for over 24,000 depression sufferers to date.
- Approximately 1 out of 3 people have experienced complete remission from depression.
- 50% of patients have drastic reductions in their symptoms.
- TMS Therapy is bringing new hope to patients and families every day.
Patients have been heard to say, "The gray is gone!"
For more information about Transcranial Magnetic Stimulation, TMS Therapy, and where to get help for depression, call us at TMS Solutions at 1-970-697-1020 or visit the Web site at www.tmssolutions.com.
To learn more about TMS Therapy and clinical trials, or search for other TMS studies, please visit www.tmssolutions.com . You can also click on the button below for more info.