Posted by lotus on September 11, 2005, at 2:52:41
After nearly six months of debate, analysis and review of clinical trials, the FDA approved the first implantable, electronic device for the treatment of depression.
Though still in experimental stages for treating depression, Cyberonics' pacemaker-like device, which is surgically implanted into a patient, has been available in the U.S. since 1997 as a treatment for epilepsy. VNS therapy delivers mild electrical shocks to the vegas nerve in the brain.
Originally designed for treating epilepsy, clinical results suggest that patients using the device report enhanced mood and lowered depression.
Regulators approved the device for use in chronic or recurrent treatment-resistent depression (TRD).
Major depressive disorder is one of the most prevalent and serious illnesses in the U.S., affecting nearly 19 million Americans every year. Depression is the second leading cause of disability for the general population and the leading cause of disability for American women. Approximately 20 percent of depressed Americans, or approximately four million people, experience chronic or recurrent treatment-resistant depression that has failed to respond to multiple antidepressant treatments. The VNS Therapy System would be the first implantable device-based treatment for depression and the first treatment developed, studied and labeled specifically for patients with treatment-resistant depression.
“FDA’s timely landmark approvable decision is a major step towards providing millions of Americans suffering from chronic or recurrent treatment-resistant depression, their families, psychiatrists and payers exactly what they desperately need—an FDA-approved, informatively labeled, long-term treatment option specifically for their lifelong and life-threatening illness,” commented Robert P. (“Skip”) Cummins, Cyberonics’ Chairman of the Board and Chief Executive Officer
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