Deep Brain Stimulator for Medically-Refractory Epilepsy Now Available in US
Deep brain stimulation (DBS) with the Medtronic DBS System (Medtronic, Dublin, Ireland) was approved by the Food and Drug Administration (FDA) last year and is now available in the US on a commercial basis. The first patient to receive the device commercially had it implanted at Emory University approximately 2 months ago and has achieved a greater than 50% reduction in seizure frequency since his system was activated.
Several health insurers have now updated their policies to include DBS therapy of the anterior nucleus of the thalami (ANT) for epilepsy as a covered indication. These include Aetna, Blue Cross Blue Shield CareFirst, and HAP and cover almost 26 million people, enabling access to this new treatment for many. Other payers are expected to follow suit to expand coverage and make this treatment more widely available.
Approval was based on results from SANTE (NCT00101933), in which patients had a median 75% reduction in seizure frequency 7 years after implantation. The full indication is for bilateral implantation ANT for stimulation as adjunctive therapy for reducing seizure frequency in adults with partial-onset epilepsy, with or without secondary generalization, whose seizures have been refractory to three or more antiepileptic drugs (AEDs). The FDA also notes that safety and effectiveness was demonstrated in patients who averaged 6 or more seizures per month with no more than 30 days between seizures in the 3 months before surgery and has not been evaluated in patients with less frequent seizures.
"The commercial availability of DBS provides an important surgical treatment option for patients who suffer from epilepsy and do not respond to medication," said Robert E. Gross, MD, PhD, MBNA Bowman chair & professor, Emory University Department of Neurosurgery, neurosurgical primary investigator for the SANTE trial. The first patient implanted since commercialization is doing very well. . . it has only been 2 months since the system was turned on, his frequency of seizures has declined by more than 50 percent, and we expect improvement to increase further with additional programming sessions."
"I have seen first-hand the negative effects of medication-resistant seizures in many of my patients - some are unable to hold a job or maintain a high quality of life," said Robert Fisher, MD, director of the Stanford Epilepsy Center, Stanford University, and lead principal investigator of the SANTE trial. "I have also seen through my involvement in the SANTE trial how DBS reduced the number and often the severity of seizures. I am excited that this treatment is now available in the U.S. to help people with uncontrolled seizures."