On Tuesday, Medtronic Inc. said that it received regulatory approval in Europe for an implantable brain simulator to treat patients that suffer from obsessive-compulsive disorder.
The company, which is based out of Minneapolis, said the approval marks the first time any type of deep brain simulation has gained CE Mark approval for treatment of a psychiatric disorder.
The battery-powered device is implanted near the collarbone or abdomen, and is then connected by a wire to electrodes placed in the brain.
It received U.S. approval in February through a humanitarian device exemption. The device’s approval allows treatment of a condition affecting less than 4,000 people a year.
OCD is an anxiety disorder that is characterized by constant upsetting thoughts, which causes the person to perform an action repeatedly in an attempt to dispel them.
The neurostimulator, according to Medtronic, is used for its Reclaim Deep Brain Stimulation Therapy. This is also used to treat common movement disorders like Parkinson’s disease and dystonia.
The device is similar to a pacemaker because it delivers electrical pulses to targeted areas of the brain.
However, the device will use a unique lead, or wire, because the area of the brain targeted for OCD is different.
Medtronic said it also plans to conduct a post-market study of the therapy at a minimum of eights sites in Europe.
Material was recently published in the journal Molecular Psychiatry from research into DBS therapy for OCD. This article showed the research had a reduction of symptoms and functional improvement in about two-thirds of the patients studied. Medtronic said that a majority of the patients moved from a severe OCD rating to a mild, or moderate, rating after the device was implanted.
Medtronic announced that it is also studying Reclaim DBS therapy in treatment-resistant depression.
On the Net: