Saturday, July 16, 2005

Business World: Cyberonics, Neurostimulator (Vagus Nerve Stimulator [VNS]), and Depression

News about this controversial issue (See the list at the bottom of this posting for earlier BrainBlog posts.)

From the company's press release:
FDA APPROVES CYBERONICS’ VNS THERAPY™ SYSTEM FOR TREATMENT-RESISTANT DEPRESSION (TRD)
First FDA-Approved Treatment Specifically for TRD First Implantable Device-Based Treatment for Depression

Conference Call Scheduled for Monday, July 18 at 8:00 AM EDT Investor/Analyst Day at Cyberonics Scheduled for July 25-26


HOUSTON, Texas, July 15, 2005 -- Cyberonics, Inc. (NASDAQ:CYBX) today announced that the United States Food and Drug Administration (FDA) approved the Vagus Nerve Stimulation (VNS) Therapy System “for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.” VNS Therapy is delivered from a small pacemaker-like generator implanted in the chest that sends preprogrammed, intermittent, mild electrical pulses through the vagus nerve in the neck to the brain. The VNS Therapy System is the first FDA-approved implantable device-based treatment for depression and the first treatment developed, studied, approved and labeled specifically for patients with treatment-resistant depression (TRD). The VNS Therapy System was approved as a treatment for medically refractory epilepsy in Europe in 1994 and in the United States and Canada in 1997 and as a treatment for TRD in Europe and Canada in 2001.
{ ... Read the Full Press Release ... ]
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Previous BrainBlog postings on this topic:

20 May 2005
19 May 2005
07 April 2005
04 February 2005
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Anthony H. Risser | | |

2 Comments:

Blogger MARYBETH said...

Hi Anthony.
Would you give me the "cliff note" version explanation of the vagus nerve??
I am a student of neuropsychiatry, and am not at all familiar with this nerve and is relationship to the brain and mood regulation.
With Gratitude,
MB

1:12 AM  
Blogger owlvee said...

How does the company "CYBERONICS" get away with not being sued. My wife had the VNS implant (For Epilepsy) five months before the wiring became faulty.
I attempted to get "CYBERONICS" help pay for surgery costs of the second VNS implant due to their faulty equipment. I was directed to their legal section where I find "CYBERONICS" has filed for, and received, protection against a lawsuit due to faulty equipment.
CYBERONICS has refused to pay anything even after admitting fault. That leaves MEDICARE and your tax money paying thousands without recourse.
CYBERONICS should pay doctor and surgery bills of the second operation. Especially since it has ben under six (6) months. In reality, CYBERONICS should also pay for duress, inconvenience, and other bills incurred due to the second operation. Please BEWARE of "CYBERONICS INC".

7:07 PM  

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