Two miniature wires wrap around the vagus nerve on the left side of the neck
and send electrical signals that stimulate the vagus nerve.
These signals are transmitted to the brain in an attempt to regulate mood.
BRAIN IMPLANTS IN USA
Major depressive disorder is characterized by persistent sadness, guilt,
physical pain, recurrent thoughts of suicide, physical slowing or agitation
and a pronounced change in appetite or sleeping.
FDA Panel Backs Cyberonics
by Otesa Middleton, Smart Money, Jun 15, 2004
WASHINGTON -- An implanted device used for treating epileptics won federal panel support Tuesday as a potential new way to manage difficult-to-treat, recurring major depression. By sending electrical signals via the vagus nerve, the device stimulates the brain as a new way to attack depression. "It is difficult to treat this group of patients," said panelist Dr. Irene E. Ortiz, of the University of New Mexico in Albuquerque. "This is almost a terminal type of condition more or less."
The Food and Drug Administration will make a final decision on the product, but the agency typically approves treatments backed by its outside panel of medical experts. The FDA is reviewing Cyberonics Inc.'s (CYBX) application for its VNS system on an expedited basis because the agency said additional depression treatments are needed once available options fail. The panel voted five to two in favor of approving the implant for those patients whose illness doesn't respond to conventional depression treatment. The panel wants the surgeons who perform the implantation to receive training and for the company to educate patients.
Cyberonics' device has been approved since 1997 to treat epilepsy, which represents a far smaller group of patients than the millions of Americans with major depression. If the FDA follows its panel's advice, as expected, Cyberonics will be able to market the device to this much-larger group of patients, said medical device analyst Thomas J. Gunderson, a managing director and senior research analyst at Piper Jaffray & Co. in Minneapolis.
Cyberonics, Mr. Gunderson said, pioneered use of an implant to treat epilepsy that now brings in $100 million in sales for the company. But as sales growth slowed, "Wall Street asked what the company was going to do next," Mr. Gunderson said. Instead of creating a new therapy, the company applied its existing product to a new disease. "The beauty of this is they get to use the exact same product," Mr. Gunderson said. By using an already approved device, there were fewer hurdles regarding the need to convince the FDA and its advisers of safety since the VNS system is already sold in the U.S., Mr. Gunderson said after the panel meeting.
To receive the device, one-hour outpatient surgery is conducted to implant the VNS system just under the skin, below the collarbone at the vagus nerve. Two miniature wires wrap around the vagus nerve on the left side of the neck and send electrical signals that stimulate the vagus nerve. These signals are transmitted to the brain in an attempt to regulate mood.
The most common side effect is a change in the sound of the patient's voice, making it sound froggy. Dr. Ortiz said Cyberonics' data convinced her of its safety. "And its seven years of use in epilepsy," she added. The company wants the $16,000 product approved for those patients who haven't gotten better after two or more available depression treatments; however, the panel said patients should have failed on four or more treatments before receiving the implants. As of last October, when Cyberonics filed its application for the new approval, the company said 22,000 patients have been treated with the implant called the VNS System. About 19 million people in the U.S. suffer from major depressive disorder, which is characterized by persistent sadness, guilt, physical pain, recurrent thoughts of suicide, physical slowing or agitation and a pronounced change in appetite or sleeping.
FDA approves brain implants for depression. WashPost, Jun 16, 2004
(implant involves connecting a wire to the left vagus nerve in the side of the neck; a battery is implanted high in the left chest or under the armpit, and the amount of current can be regulated externally. Typically, the implant sends a 30-second pulse of current followed by a five-minute pause, 24 hours a day)
VONNEGUT'S HARRISON BERGERON (movie about schools using electric shock to "equalize" students)
MIND-CONTROL PART 1: CANADIAN & USA SURVIVORS SEEK JUSTICE ("Curiously, often a classic manifestation of people who are afflicted with certain psychotic disorders is the irrational fear that the CIA and FBI is conspiring to harm them. In this case, the CIA involvement is real and the covert nature of the involvement is not contested."). Probe Magazine, Mar/Apr 2000
ELECTRIC SHOCK TEACHING IN BRAVE NEW WORLD and 40.Electric Shock Brainwashing and 14.Scientific Experimentation and 20.Thoughtcrime
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