The Food and Drug Administration (FDA) has granted premarket approval for Medtronic’s Deep Brain Stimulation (DBS) therapy – a surgically implanted medical device – as an adjunctive treatment for reducing the frequency of partial-onset seizures in those who are refractory to ≥3 antiepileptic medications.
The approval is specifically for bilateral anterior thalamic nucleus stimulation and is based on results from the SANTE study (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy). This randomized, double-blind study enrolled 110 individuals who were implanted with the Medtronic DBS system and had a 7-year open-label follow up.
Results showed that at 3 months, the total median seizure frequency reduction was 40.4% vs 14.5% for the DBS and placebo groups from baseline, respectively. At 7 years, the total median seizure frequency reduction was 75% with open-label ongoing therapy. In addition, 18% (n=20) of patients experienced at least one 6-month period in which they were seizure free between the time of implant and Year 7, and 7% (n=8) of these patients were seizure-free for the previous 2 years.
Quality of life and seizure severity were statistically significantly improved from baseline at Year 7. Moreover, no significant worsening of cognitive or depression scores was seen through the blinded phase or at Year 7; improvements in measures of executive function and attention were noted at the 7-year point.
Adverse events (AE) were assessed for 2 years following device implantation. The most common AEs were paresthesia (23/110), implant site pain (18/110), and implant site infection (10/110).
Medtronic plans to launch their DBS therapy sometime this year.