Only twenty-seven patients were implanted with the VNS Therapy System(TM) for TRD during the past 90-days.
We are now entering the fourth year of FDA's final approval of vagus nerve stimulation to treat major depressive disorder. Cyberonics, the manufacturer of the vagus nerve stimulator continues to execute on its previously announced plan to focus primarily on the epilepsy market.
From February 22nd 2008 to April 25th, a total of twenty-seven patients in the United States were implanted with the VNS Therapy SystemTM for depression. That is about one patient for every two states. Cyberonics continues to seek a financial partner or joint venture for a new depression clinical study.
Unfortunately, I think that universal reimbursement for non-pharmacological based treatments (excluding ECT and psychotherapy) such as VNS, TMS, FEAST, and DBS is many years away. Below is a painful reminder of Medicare's National Coverage Determination for vagus nerve stimulation (VNS):
"CMS (Centers for Medicare and Medicaid Services) believes almost all correctly identified depressed patients can be successfully treated for depression" [HELLO?]
"CMS has determined that there is sufficient evidence to conclude that vagus nerve stimulation is not reasonable and necessary for treatment of resistant depression. Accordingly, we are issuing the following national coverage determination:
Vagus nerve stimulation is not covered for treatment resistant depression."*


