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.
https://www.medscape.com/viewarticle/896001
No comments:
Post a Comment