Posted on February 19, 2009 · Posted in Brain Injury

Date: 2/19/2009

AP Business Writer

WASHINGTON (AP) — Patients suffering from obsessive, distressing thoughts have a new treatment option: a pacemaker-like device that relieves anxiety with electrical jolts to the brain.

The Food and Drug Administration on Thursday approved Medtronic’s Reclaim Deep Brain Stimulator device as the first implant to treat obsessive-compulsive disorder, which causes uncontrollable worries, such as fear of germs or dirt.

Patients suffering from the disorder try to relieve their anxiety with obsessive behavior, such as washing their hands or checking locks repeatedly.

“These are obtrusive thoughts that take control of people’s lives to the point that they lose their jobs, can’t have relationships and in many cases, can’t even leave their homes,” said Dr. Hooman Azmi of Hackensack University Medical Center.

While about 2.2 million Americans have the disorder, the new device would only be available to a small group of patients who don’t respond to other treatments, such as antidepressant drugs and therapy.

The FDA approved the device under a program reserved for conditions that effect fewer than 4,000 people each year.

The FDA’s director for devices stressed that Reclaim provides some relief, but patients likely will have to continue taking medications as well.

“Reclaim is not a cure,” Dr. Daniel Schultz said in a statement. “Individual results will vary and patients implanted with the device are likely to continue to have some mild to moderate impairment.”

Shaped like a pacemaker, the Reclaim device is implanted under the skin of the chest and then connected to four electrodes in the brain. The electrodes deliver steady pulses of electricity that block abnormal brain signals.

Similar devices have been used since the 1990s to treat movement disorders like Parkinson’s disease and tremors. But where prior devices target areas of the brain that deal with movement, Medtronic said its product delivers electrical signals to areas that control mood and anxiety.

“What deep brain stimulation does is modulate those circuits that we believe are hyperactive in patients with obsessive compulsive disorder,” said Paul Stypulkowski, the company’s senior director of research.

Medtronic Inc., the world’s largest medical device maker, also is studying the use of the technology in patients with severe depression.

In 2005, rival Cyberonics became the first company to win FDA approval for a device to treat depression. However, the company’s Vagus Nerve Stimulator has been plagued by questions of effectiveness.

Members of Congress and consumer watchdog groups campaigned against the Cyberonics device, citing research that some patients who have received it had worsening depression. A number of insurers, including the government’s Medicare program, have refused to pay for the device in depression patients.

Medtronic representatives point out that their technology differs from that used by Houston-based Cyberonics, which delivers an electrical signal to nerves in the neck. Medtronic’s devices stimulate the brain directly.

Shares of Minneapolis-based Medtronic fell 20 cents to $34.13 Thursday.

Copyright 2009 The Associated Press.

About the Author

Attorney Gordon S. Johnson, Jr.
Past Chair Traumatic Brain Injury Litigation Group, American Association of Justice :: 800-992-9447