The DBS treatment is cleared for patients 18 years or older who are refractory or drug resistant to three or more antiepileptic medications, the Fridley, Minn.-based company said.
Medtronic’s DBS therapy functions through the delivery of controlled electrical pulses to the anterior nucleus of the thalamus which is part of a network involved in seizures, the company said.
Approval came based on seven years of data from the company’s Sante trial, which examined the use of the DBS system in 110 patients with medically refractory epilepsy with partial-onset seizures.
“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,” Sante trial lead principal investigator Dr. Robert Fisher of the Stanford Epilepsy Center said in a prepared statement.
Results from the Sante trial indicated the median total seizure frequency reduction from the baseline was 40.4% at three months, versus 14.5% in a placebo group, and 75% at seven years.
A total 18% of subjects had at least one six-month seizure-free period between the implant and the seventh year, with 7% of patients reporting to be seizure-free for two years prior to the seven-year follow-up.
Seizure severity and quality of life were shown to have statistically significant improvements from baseline at the seventh year, with no cognitive declines or worsening depressions cores, Medtronic 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 U.S. during the course of this year,” Medtronic brain modulation biz GM Mike Daly said in a press release.
Yesterday, Medtronic said it won expanded approval from the FDA for its Infuse bone growth protein implant, marking the second expansion for the implant over the past two years.