Spectrum Health to Offer Implantable Neurostimulator for Hard-to-Treat Epilepsy Patients
Spectrum Health will be the first health system in West Michigan and among the first in the nation to offer treatment with a newly FDA-approved device that uses electric stimulation of the brain for adult epilepsy patients whose seizures have not responded to medication.
The NeuroPace® Responsive Neurostimulation (RNS®) System is an implantable therapeutic device designed to detect abnormal electrical activity in the brain and respond by delivering imperceptible electrical stimulation to normalize brain activity before an individual experiences seizures.
"For patients with frequent and disabling partial onset seizures who have proven unresponsive to two or more medications and who are not candidates for actual removal of abnormal tissue, this may prove to be a viable and welcome treatment option," said Kost Elisevich, MD, PhD, neurosurgeon, co-chair department of clinical neurosciences, chief, division of neurosurgery, Spectrum Health Medical Group.
The RNS System is designed for use in combination with other therapies in reducing the frequency of seizures in individuals 18 years of age or older. It is indicated for use in patients with partial onset seizures – seizures that originate and remain in a limited area of the brain. To be eligible for the procedure, patients must have frequent and disabling seizures (motor partial seizures, complex partial seizures and/or secondarily generalized seizures), whose origin is limited to two or fewer locations in the brain.
NeuroPace, Inc. estimates that approximately 400,000 people in the U.S. meet these criteria and may benefit from treatment with the RNS System.
"Neurostimulation could provide relief from seizures for many patients who are not good candidates for surgery," said Brien Smith, MD, co-chair, department of clinical neurosciences, chief, division of neurology, Spectrum Health Medical Group, and immediate past chair of the National Epilepsy Foundation. "We plan to offer this treatment to eligible patients as soon as it becomes available."
The U.S. Food and Drug Administration (FDA) granted premarket approval for the RNS System on November 14. While employed at Henry Ford Health System, Drs. Elisevich and Smith were one of the first clinical teams in the nation to participate in clinical trials using the RNS System. The device has been evaluated for more than eight years in three clinical trials at 32 comprehensive epilepsy centers in the U.S., including a prospective, randomized, double-blinded, sham stimulation controlled pivotal study.
The pivotal study demonstrated a nearly 38 percent reduction in seizure frequency in patients treated with responsive stimulation compared to an approximately 17 percent reduction in patients who were implanted with the device but were not receiving responsive stimulation during a three month blinded period. In a two-year follow-up phase, 55 percent of the subjects experienced a 50 percent or greater reduction in seizures.
Treatment with the RNS System will take place in Level 4 epilepsy centers throughout the nation following site qualification and physician training. Spectrum Health is the first epilepsy program in West Michigan to receive a Level 4 designation by the National Association of Epilepsy Centers (NAEC). Level 4 centers have the professional expertise and facilities to provide the highest level of medical and surgical epilepsy evaluation and treatment for patients with epilepsy.
Spectrum Health is a not-for-profit health system, based in West Michigan, offering a full continuum of care through the Spectrum Health Hospital Group, which is comprised of 11 hospitals including Helen DeVos Children's Hospital; 170 ambulatory and service sites; 1,050 advanced practice providers and employed physicians including members of the Spectrum Health Medical Group; and Priority Health, a 537,000-member health plan. Spectrum Health is West Michigan's largest employer with 20,900 employees. The organization provided $250 million in community benefit during its 2013 fiscal year.