On October 19, 2004, it was announced by Cyberonics, Inc., the maker of the device used for Vagus Nerve Stimulation, that the FDA has granted approval to make Vagus Nerve Stimulation Therapy available to up to 100 patients with life-threatening treatment-resistant depression (TRD) in a multi-center, open-label, uncontrolled, longitudinal trial, while FDA completes its review of the Expedited Review PMA-Supplement Amendment submitted on September 23, 2004. As described on the FDA’s website (http://www.fda.gov/cdrh/devadvice/ide/early.shtml), the purpose of a Treatment IDE is to facilitate the availability of promising new devices to desperately ill patients, and a Treatment IDE is considered when (1) the device is intended to treat a serious or immediately life-threatening disease, (2) there is no comparable or satisfactory alternative device or other therapy to treat that stage of the disease or condition in the intended patient population, (3) the device is under investigation or the clinical trials have been completed for the same use, and (4) the sponsor is actively pursuing marketing approval/clearance of the device with due diligence.
The device used for this therapy (currently only approved for epilepsy treatment), is often referred to as a "pacemaker for the brain". The system consists of a pulse generator and a nerve stimulator electrode that is usually programmed to send 30-second electrical impulses every 5 minutes to the left vagus nerve, via connecting leads. The generator is surgically placed in a pocket formed under the skin, below the left collarbone. It's disc shaped and about the size of an baby's palm. It is similar in appearance and size to a cardiac pacemaker. The surgery takes about forty-five minutes, and is considered a safe procedure with very little risk. The generator's "dosage of stimulation" is adjusted non-invasively through the skin using a computerized programmer.
Currently, the Vagus Nerve Stimulation Therapy System is approved for sale in the European Economic Area and in Canada as a treatment for depression in patients with treatment-resistant or treatment-intolerant major depressive episodes including unipolar depression and bipolar disorder (manic depression). In the US, Vagus Nerve Stimulation Therapy is at various levels of investigational clinical study as a potential treatment for depression, anxiety disorders, Alzheimer’s disease, and chronic headache/migraine.
If you would like more information about Vagus Nerve Stimulation or where Cyberonics currently is in the FDA approval process, you may visit their Web site at: http://www.cyberonics.com.
