Medtronic plc (NYSE:MDT) announced on 5/1/18 that the U.S. Food and Drug Administration (FDA) has granted premarket approval for Medtronic's Deep Brain Stimulation (DBS) therapy as adjunctive treatment for reducing the frequency of partial-onset seizures, in individuals 18 years of age or older who are refractory, or drug-resistant, to three or more antiepileptic medications. DBS therapy for epilepsy delivers controlled electrical pulses to a target in the brain called the anterior nucleus of the thalamus (ANT), which is part of a network involved in seizures.
"Many patients in the United States with severe epilepsy are not able to control their seizures with currently-available drugs and are not candidates for potentially curative surgery," said Dr. Robert Fisher, director of the Stanford Epilepsy Center, Stanford University, and lead principal investigator of the SANTE trial. "Epilepsy that is refractory to AED treatment is an unsolved problem, and DBS therapy will now serve as an important new treatment option, including for people with poorly localized or multiple regions of seizure origin."
According to the Epilepsy Foundation, 3.4 million individuals in the United States have epilepsy. Antiepileptic drug (AED) medication is the primary treatment to control seizures; however, up to one third of individuals with epilepsy have seizures that do not successfully respond to AEDs.
DBS therapy uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver electrical stimulation to precisely targeted areas of the brain as adjunctive treatment for several neurological disorders. Medtronic DBS systems are the first and only approved for full-body MRI scans under specific conditions in the United States. Since 1997, more than 150,000 Medtronic DBS devices have been implanted worldwide for movement disorders and other indications.
In addition to medically refractory epilepsy, DBS therapy is currently approved in many locations around the world, including the United States and Europe, for the treatment of the disabling symptoms of essential tremor and recent and longer-standing Parkinson's disease. Under Humanitarian Device Exemption (HDE) approvals in the United States, the therapy can also be used to treat chronic intractable primary dystonia and severe, treatment-resistant obsessive-compulsive disorder.
