Shades of Psychlo Brain Implants - The FDA is at it again!!!

[Guest guest]

http://www.fda.gov/bbs/topics/NEWS/2009/NEW01959.html

 

 

 

This is just too much. The FDA looking after our

Health Interests one more time.

Yours in Knowledge, Health and Freedom,

Doc

 

FDA News Release

 

FDA Approves Humanitarian Device Exemption for Deep Brain Stimulator

for Severe Obsessive-Compulsive Disorder

The U.S. Food and Drug Administration today approved a humanitarian

device exemption for the first implantable device that delivers

intermittent electrical therapy deep within the brain to suppress the

symptoms associated with severe obsessive-compulsive disorder (OCD).

The U.S. Food and Drug Administration today approved a humanitarian

device exemption for the first implantable device that delivers

intermittent electrical therapy deep within the brain to suppress the

symptoms associated with severe obsessive-compulsive disorder (OCD).

The Reclaim system uses a small electrical generator known as a

pulse generator to create electrical stimulation that blocks abnormal

nerve signals in the brain. This small battery-powered device is

implanted near the abdomen or the collar bone and connected to four

electrodes implanted in the brain through an insulated electric wire

known as the lead. Two device systems may be implanted to stimulate

both sides of the brain or one device may be implanted with two lead

outputs.

Human device exemptions facilitate the development of medical

devices intended to treat or diagnose a disease or condition affecting

fewer than 4,000 people per year in the United States. To receive

approval, a company must demonstrate the safety and probable benefit of

the device.

“Deep brain stimulation using the Reclaim system may provide some

relief to certain patients with severe obsessive compulsive disorder

who have not responded to conventional therapy,” said Daniel Schultz,

M.D., director, Center for Devices and Radiological Health. “However,

Reclaim is not a cure for OCD. Individual results will vary and

patients implanted with the device are likely to continue to have some

mild to moderate impairment in functioning and continue to require

medications.”

OCD is an anxiety disorder and is characterized by recurrent,

unwanted thoughts (obsessions) and/or repetitive behaviors

(compulsions). Repetitive behaviors such as handwashing, counting,

checking, or cleaning are often performed with the hope of preventing

obsessive thoughts or making them go away. Performing these actions

provides only temporary relief, but not performing them markedly

increases anxiety.

The approval of the human device exemption was based on a review of

data from 26 patients with severe treatment resistant OCD who were

treated with the device at four sites. On average, patients had a 40

percent reduction in their symptoms after 12 months of therapy. While

all patients reported adverse events, the majority of these events

ended after an adjustment was made in the amount of electrical

stimulation.

Patients who require electroconvulsive shock therapy should not be

implanted with the Reclaim device. Other patients who should not use

the device include persons who will undergo magnetic resonance imaging

(MRI) or deep tissue heat treatment known as diathermy.

 

 

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