Posted by jrbecker on June 16, 2004, at 9:52:55
In reply to FDA says VNS device lacks data, posted by jrbecker on June 14, 2004, at 15:46:02
official FDA approval is now pending...
http://www.thestreet.com/stocks/biotech/10166168.html
Cyberonics Ignites on FDA OK
By TSC Staff
6/16/2004 8:30 AM EDTCyberonics (CYBX:Nasdaq - news - research) vaulted to the top of both volume and percentage gainer boards Wednesday morning after a Food and Drug Administration panel recommended approval of its pacemaker-like nerve stimulator for treatment of severe depression.
The stock, which was halted Tuesday ahead of the decision, was recently up $15.66, or 80%, to $35.35 on Instinet, trading more than half a million shares in the first 30 minutes.
Despite a fair amount of bearish ridicule in the run-up to the meeting, the FDA's Medical Device Advisory Committee voted 5-2 to recommend the VNS Therapy System in patients "experiencing a major depressive episode that has not had an adequate response to four or more adequate antidepressant treatment."Cyberonics will have to change labeling to reflect advice that doctors and implanting surgeons have appropriate experience and adequate training with the device, and that patients be educated in its use. It will also have to set up a long-term registry of patients receiving the device.
The VNS consists of a generator and nerve stimulator electrode that delivers a mild, intermittent electrical signal to the vagus nerve in the left side of a patient's neck. The company believes that stimulation of the nerve "produces widespread and bilateral effects in parts of the brain implicated in epilepsy, depression, anxiety, memory ... and responsible for modulation of key neurotransmitters such as serotonin and norepinephrine."
poster:jrbecker
thread:356642
URL: http://www.dr-bob.org/babble/20040614/msgs/357188.html