FDA Approves Cyberonics Depression Device (Public Citizen: it's unproven)

[HuckleB]

FDA Approves Cyberonics Depression Device

http://www.medscape.com/viewarticle/508548

"An implanted stopwatch-sized device that uses electrical vagal stimulation to treat chronic depression won U.S. Food and Drug Administration approval, Cyberonics said on Friday.

The device, known as the Vagus Nerve Stimulation Therapy System (VNS), was cleared by the FDA for long-term use in adults whose depression has not responded to other treatments.

FDA officials cautioned that the VNS device is not to be used as the first therapy but would give the sickest patients another option. "We're really dealing with a very sick group of patients here. These are not standard depression patients," said Dr. Daniel Schultz, director of the FDA's device center.

The device would carry the strongest warning possible -- a so-called black box -- cautioning patients that the device is permanent, Schultz said in an interview. Cyberonics will also have to create a registry to monitor some patients.

..."

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Group Attacks Depression Device Approval

http://my.webmd.com/content/Article/108/109057.htm

"An FDA watchdog group criticized the agency's recent approval of a new electrical stimulation device for depression Monday. It says that the device has not been proven to work and may increase patients' risk of suicide.

The device, called a Vagus Nerve Stimulator (VNS), was approved for U.S. sales Friday. But Public Citizen, an FDA and medical industry monitoring group, says that the device does not meet government standards for safety and efficacy and has not been adequately studied.

The device is also the subject of an ongoing investigation on Capitol Hill, where some lawmakers are questioning its approval.

VNS is a small electrical generator that is surgically implanted under the skin, where it delivers an electrical pulse every five seconds through wires wrapped around the vagus nerve. The vagus nerve runs from the neck to the brain. The nerve is thought to have some control over mood regulation.

..."

also...

Approval of Device to Treat Depression Is One of Most Questionable FDA Decisions in Recent Memory

http://www.commondreams.org/news2005/0718-11.htm

[htuttle]

1. Wireheads...can't stand 'em

[area51]

2. Cyberonics article

Here is a link to an article on Cyberonics & their device (link opens in new window).