The approval hinged on an fda humanitarian device exemption which applies to treatments for diseases rare enough that it s difficult to impossible to enroll enough patients to run effective.
Brain stimulation device for ocd.
It will be used as a last ditch therapy to treat patients who have failed multiple different therapies for ocd.
The placement of the electrodes and the decision about how much stimulation is given is crucial.
Deep brain stimulation for highly treatment resistant ocdby darin dougherty md and benjamin greenberg md ph d.
Healthday a brain stimulation device to treat obsessive compulsive disorder ocd has received approval for marketing friday by the u s.
It s also approved for use by the food and drug administration to reduce seizures in difficult to treat epilepsy.
The fda recently approved dbs for treatment resistant ocd under a humanitarian device exemption hde.
Deep brain stimulation is the new ocd treatment deep brain stimulation can be the answer for severe ocd patients.
Food and drug administration.
In february 2009 the fda granted medtronic corporation a humanitarian device exemption for the use of one of its deep brain stimulation devices for refractory obsessive compulsive disorder which.
In 2009 the fda approved deep brain stimulation for obsessive compulsive disorder ocd that s severe to extreme which isn t a movement disorder.
Deep brain stimulation dbs is a neurosurgical procedure involving the placement of a medical device called a neurostimulator sometimes referred to as a brain pacemaker which sends electrical impulses through implanted electrodes to specific targets in the brain brain nuclei for the treatment of movement disorders including parkinson s disease essential tremor and dystonia.
The hde approval assumes a relatively small number of patients will receive the treatment.
While most patients with obsessive compulsive disorder ocd eventually respond to treatment with medication and or behavioral therapy a small minority.