FOR IMMEDIATE RELEASE: Nov. 21, 2013
Contacts: Clay Holtzman, Swedish, 206-386-2748, firstname.lastname@example.org
Laura Allen – Swedish Epilepsy Center 206-320-3492
SEATTLE – The U.S. Food & Drug Administration has granted pre-market approval to a California company’s device for the treatment of medically refractory epilepsy that Swedish Neuroscience Institute played a key role in evaluating.
The NeuroPace® RNS® System, a treatment for adults with partial onset seizures that have not been controlled with two or more antiepileptic drugs, received FDA premarket approval on Nov. 14, 2013. Created by Mountain View, Calif.-based NeuroPace, the RNS System is a novel, implantable therapeutic device that delivers responsive neurostimulation, an advanced technology designed to continuously monitor electrical activity in the brain, detect abnormal activity and respond by delivering imperceptible levels of electrical stimulation to normalize that activity before an individual experiences seizures.
Swedish physician Ryder Gwinn, M.D., medical director of the Swedish Neurosciences Institute Center for Neuromodulation and Functional Restoration, served as a principal investigator for the device’s feasibility and clinical trials. Swedish was one of 11 centers that evaluated the device’s feasibility and one of 32 centers that conducted the pivotal trial that led to FDA premarket approval. Swedish Neuroscience Institute will initially be the only center in the Pacific Northwest to implant the device.