FDA Gives Limited Approval to Implanted Brain Stimulator for Treatment of Severe OCD

The U.S. Food and Drug Administration has given limited approval to an implantable deep brain stimulator, made by Medtronic Inc., for the treatment of severe obsessive-compulsive disorder.

The Reclaim DBS Therapy device, already approved for help treating tremors associated with Parkinson’s disease, is not FDA-approved for treatment of obsessive-compulsive disorder (OCD). The anxiety disorder commonly forces people in response to stress to perform repeated actions, such as frequent hand washing, cleaning, counting, or similar actions.

Humanitarian Exemption Granted

Under an exemption for the limited use of unapproved medical devices and drugs products for humanitarian reasons, the FDA has granted Medtronic the right to sell up to 4,000 of the devices for use in OCD patients. In order to gain a humanitarian exemption, a medical device maker must demonstrate that the product is safe and likely to benefit patients.

In the case of the Reclaim DBS Therapy device, Medtronic says the treatment may benefit OCD sufferers who have not responded to other conventional treatments.

However, the brain stimulator is not a cure for OCD and officials said the individual results of the treatment will vary depending on many factors. Mild to moderate impairment in functioning is likely to continue in some OCD sufferers who receive the Reclaim treatments.

Positive Results Noted

The FDA gave limited humanitarian approvals to the Reclaim deep brain stimulator to be used in OCD cases after reviewing reports of 26 OCD patients who showed a 40 percent reduction of symptoms after using the device for one year.

Reclaim DBS Therapy is a battery-powered device which is implanted either near the collar bone or the abdomen. The device is then connected by a wire to electrodes placed in the brain and a small generator sends electrical pulses to stimulate both sides of the brain to reduce OCD symptoms.

The treatment should be available to use in OCD patients in mid-2009 at a cost of about $60,000, Medtronic officials said. Health insurers would decide whether to pay for the treatment on a case-by-case basis, he added.

Humanitarian Exemptions Can Be Abused

Medical device companies have abused humanitarian exemptions before and sold products for uses that are neither FDA approved nor for humanitarian uses. In 2009, two former Stryker Corp. sales associates admitted selling products designed to increase bone growth in spinal-cord injury cases for purposes not covered by an FDA humanitarian approval. The FDA had given a humanitarian use exemption to the products, but Stryker sold the items to patients not covered by that waiver.

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