The US Food and Drug Administration (FDA) has granted premarket approval for Medtronic's deep-brain stimulation (DBS) therapy as adjunctive treatment for seizure reduction in adults with refractory epilepsy, the company announced.
In a release, the company reports that the FDA approval is based on both the blinded-phase and the 7-year follow-up data collected in Medtronic's clinical trial, called Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy (SANTE).
The prospective, randomized, double-blind pivotal study evaluated DBS therapy in patients with medically refractory epilepsy and partial-onset seizures, with or without secondary generalization, that were resistant to three or more antiepileptic drugs (AEDs).
The trial collected data from 110 patients who were implanted with a Medtronic DBS system at 17 centers in the United States.
The results showed a 40.4% median reduction in total seizure frequency, vs 14.5% for the placebo group, at 4 months and a median 75% reduction at 7 years with open-label, ongoing therapy.
Twenty patients (18%) experienced at least one 6-month seizure-free period between implant and year 7, including 8 patients (7%) who had been seizure-free for the preceding 2 years.
Medtronic also reports that seizure severity and quality-of-life scales statistically significantly improved from baseline at year 7. In addition, the company says there was no cognitive decline or worsening of depression scores through the blinded phase or at year 7. Medtronic says measures of executive functions and attention were improved at 7 years.
"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.
"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," principal investigator, Robert Fisher, director of the Stanford Epilepsy Center, Stanford University in California, said in a release.