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Dr. Bob is Robert Hsiung, MD,
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Posted by Wildflower on February 3, 2005, at 10:38:52
Pacemaker-like device delivers electrical impulses to brain
Updated: 7:52 p.m. ET Feb. 2, 2005LOS ANGELES - U.S. regulators have given conditional approval to Cyberonics Inc.’s application to market an implanted device to treat depression, the company said Wednesday.
The VNS Therapy System is a pacemaker-like device that delivers electrical impulses to the brain. Cyberonics already sells the implant for reducing seizures from epilepsy.
The FDA said approval was conditional on final labeling, protocols for a post-marketing dosing study and patient registry as well as compliance with quality system regulations and resolution of any outstanding monitoring issues.
Posted by Phillipa on February 3, 2005, at 17:02:32
In reply to FDA Approves Implant for Depression Treatment, posted by Wildflower on February 3, 2005, at 10:38:52
Someone Posted the entire information sheet in a Post above. Exactly what does this mean for the majority of people with longterm depression/anxiety? Many years before use, lots of money? Fondly Phillipa
Posted by KaraS on February 4, 2005, at 23:41:32
In reply to FDA Approves Implant for Depression Treatment, posted by Wildflower on February 3, 2005, at 10:38:52
> Pacemaker-like device delivers electrical impulses to brain
> Updated: 7:52 p.m. ET Feb. 2, 2005
>
> LOS ANGELES - U.S. regulators have given conditional approval to Cyberonics Inc.’s application to market an implanted device to treat depression, the company said Wednesday.
>
> The VNS Therapy System is a pacemaker-like device that delivers electrical impulses to the brain. Cyberonics already sells the implant for reducing seizures from epilepsy.
>
> The FDA said approval was conditional on final labeling, protocols for a post-marketing dosing study and patient registry as well as compliance with quality system regulations and resolution of any outstanding monitoring issues.
>I'm glad you posted this. I didn't know anything about VNS and so wasn't aware that it involved brain surgery.
Posted by mmcconathy on February 8, 2005, at 17:37:06
In reply to Re: FDA Approves Implant for Depression Treatment » Wildflower, posted by KaraS on February 4, 2005, at 23:41:32
Thats awsome, but lets hope the new technological side effects wont be fatal
This is the end of the thread.
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