FDA approves new OCD treatment device

Hackensack, New Jersey, February 20: Patients with severe obsessive-compulsive disorder (OCD) may be treated with a new pacemakerdefine-like device that has the ability to control compulsive behavioral outbreaks.

The new device called Medtronic's Reclaim deep-brain stimulation (DBS) device has been approved by the FDA, under “humanitarian device exemption".

Though FDA has approved the device, it maintained that DBS can only be used for the most severely affected patients with OCD.

The new device can be implanted in the brains of patients with obsessive-compulsive disorder (OCD).

The physicians will be able to use DBS only if all the other possible therapies for OCD fail to bring out desired results in particular cases. DBS will be the last option for the physicians.

Hackensack University Medical Center neurosurgeon Hooman Azmi, MD, said, "This is essentially like a pacemakerdefine for the brain. There is an electrode implanted in brain and wires run under the skin and attached to a generator that is also implanted in the body. And doctors have control where they can decrease or increase the electrical stimulation."

The effectiveness of DBS was tested in a clinical study that was conducted on 26 patients at three U.S. medical centers. And FDA’s decision to allow the use of DBS was based on the findings of the study.

In the Greenberg study, the patients showed significant improvement. After DBS implantation; some patients could work normally, some patients could carry on relationships and participate in other life activities.

It was found in the study that use of DBS could have side effects on some of the patients also. Eleven out of 26 patients experienced 23 serious adverse events with deadly cerebral hemorrhagedefinedefine and brain infection being most dangerous ones that could pose a threat to life.

Close to about 4,000 patients are drastically affected by OCD. Therapies currently available for treating OCD have not been effective enough. However, doctors are hopeful that the new device will be the promising option.

In a news release, lead researcher of the study Benjamin D. Greenberg, MD, PhD, remarked that DBS is a promising tool and can be used successfully for patients who do not respond to aggressive use of medications and cognitive behavioral therapy.

The device implantation can be risky for the patients, so, it cannot be used for all OCD sufferers, Azmi held.