Medtronic has received premarket approval (PMA ) from the US Food and Drug Administration (FDA) for deep brain stimulation (DBS) therapy as an adjunctive treatment for epilepsy.
The indication allows the use of the therapy to minimise the frequency of partial-onset seizures in patients aged 18 years or above who are refractory or resistant to three or more antiepileptic drugs.
Medtronic’s DBS therapy employs a surgically implanted device to deliver controlled electrical pulses to the anterior nucleus of the thalamus (ANT) region of the brain that is associated with seizures.
Previously, the therapy was approved to treat the disabling symptoms caused by essential tremors and Parkinson’s disease.
The latest indication is based on the data obtained from the prospective, randomised, double-blind Sante clinical trial conducted at 17 US centres in subjects with medically refractory epilepsy characterised by partial-onset seizures, with or without secondary generalisation.
In 110 patients implanted with a Medtronic DBS system, a 40.4% decrease in median total seizure frequency from baseline was observed, when compared to 14.5% receiving placebo.
Furthermore, the participants demonstrated statistically significant improvements in seizure severity and quality of life recorded at year seven.
Medtronic Brain Modulation business vice-president and general manager Mike Daly said: “We are very pleased to have completed the review process for DBS for epilepsy with the FDA, and we are extremely grateful to the patients and their treating teams for their commitment to the SANTE trial and this therapy over many years.
“We look forward to beginning the launch of this therapy in the US during the course of this year.”
