Deep Brain Stimulation for Medically Refractory Epilepsy Launched in U.S.

Several Health Insurers Now Consider DBS Therapy for Epilepsy a Covered Indication

Medtronic plc has launched the Deep Brain Stimulation (DBS) for medically refractory epilepsy, and the first patient has received commercial implantation. According to the Epilepsy Foundation, up to 3.4 million Americans have epilepsy, one-third of whom are believed to be drug-resistant.

DBS therapy delivers controlled electrical pulses to the anterior nucleus of the thalamus (ANT), part of a network involved in seizures. The Medtronic DBS System for Epilepsy is indicated as adjunctive therapy for reducing seizure frequency in individuals aged 18 years or older diagnosed with epilepsy characterized by partial-onset seizures, with or without secondary generalization, who are refractory to three or more antiepileptic medications. The system has demonstrated safety and effectiveness in patients averaging six or more seizures per month over the three most recent months (with no more than 30 days between seizures).

ANT-DBS therapy has been shown to significantly reduce the frequency and severity of seizures and improve quality of life for up to seven years. The first patient implanted since commercialization has experienced a decline in seizure frequency by more than 50% and further improvements are expected with additional sessions.

FDA approval and supporting clinical evidence have led several health insurers, including Aetna and Blue Cross Blue Shield CareFirst, to include ANT-DBS therapy for epilepsy as a covered indication. Medtronic is working with other insurers to expand coverage to more patients.

DBS therapy is also currently approved for the treatment of essential tremor and recent and longer-standing Parkinson’s disease. And through Humanitarian Device Exemption (HDE) approvals in the U.S., DBS can be used to treat chronic intractable primary dystonia and severe, treatment-resistant obsessive-compulsive disorder.

Source: Medtronic, February 20, 2019