Medtronic plc has announced five-year results from the pivotal SANTE (Stimulation of the anterior nucleus of the thalamus in epilepsy) trial, the largest clinical study of deep brain stimulation (DBS) therapy for epilepsy in adults with treatment-resistant (refractory) epilepsy characterised by partial-onset seizures. The results, which were recently published online by Neurology and will be printed in their March 2015 issue, include safety, efficacy and quality of life outcomes associated with long-term Medtronic DBS Therapy.
SANTE study results at five years include:
- Medtronic DBS therapy for epilepsy was associated with a sustained and statistically significant reduction in seizure frequency from baseline that continued to improve over time: 69% median seizure reduction from baseline at five years and 41% at one year (p
- The percentage of responders (patients with seizure reduction of 50% or greater) was 68% at five years and 43% at one year.
- A seizure-free interval of at least six months during five years of therapy was reported by 16% of patients.
- Statistically significant seizure severity and quality of life improvements were observed over baseline at five years and one year as measured by the Liverpool Seizure Severity Scale (LSSS) and Quality of Life measure (QOLIE-31) (p
- The most common serious adverse event through five years was implant site infection, with a rate of 10%.
- There were no device-related deaths and no unanticipated adverse device effects. Device-related implantation problems were reversible and as expected with this surgical procedure.
Medtronic DBS therapy for epilepsy uses a surgically implanted medical device to deliver electrical stimulation to a target in the brain called the anterior nucleus of the thalamus, which has strong connections to other parts of the brain where seizures begin. Medtronic DBS therapy is approved in more than 30 countries, including Canada, Australia and countries in the European Union, as adjunctive treatment for partial-onset seizures in adults with medically-refractory epilepsy. This therapy is not approved by the US Food and Drug Administration (FDA) for commercialisation in the United States. Medtronic is working to obtain commercial approval of the therapy in the United States.
“The latest SANTE study findings provide important insights into the long-term benefits of DBS therapy, which are encouraging for patients with severe partial epilepsy who are resistant to other treatments and are not candidates for resective epilepsy surgery,” says Vicenta Salanova, professor of Neurology, Indiana University School of Medicine, USA and lead author of the publication. “Long-term treatment efficacy is critical for people suffering from epilepsy, and it is particularly remarkable that DBS therapy is helping treatment-resistant patients to achieve sustained reduction in seizure frequency and severity over time while also leading to meaningful improvements in quality of life.”
“The SANTE trial continues to provide the medical community with valuable, real-world insight into the benefits of DBS therapy for people with refractory epilepsy,” says Lothar Krinke, vice president and general manager of the Brain Modulation business at Medtronic. “We are committed to providing physicians and researchers worldwide with robust clinical and pre-clinical data, including comprehensive registries, to help appropriate severe epilepsy patients who have not been successful with other treatments. We also continue to work with the FDA to make this therapy available to the right patients in the United States.”