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.

Go deeper with GlobalData

Go deeper with GlobalData

The gold standard of business intelligence.

Find out more

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

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.

“In 110 patients implanted with a Medtronic DBS system, a 40.4% decrease in median total seizure frequency from baseline was observe.”

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.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

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.”

Medical Device Network Excellence Awards - Nominations Closed

Nominations are now closed for the Medical Device Network Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact

Excellence in Action
HemoSonics has won the 2025 Marketing Award for its impactful promotion of theQuantra Hemostasis System and leadership in blood management education. See how targeted campaigns, thought leadership content, and hands on clinician training are accelerating Quantra’s market traction and shaping the future of hemostasis testing.

Discover the Impact