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KOMO News reports on new FDA-approved device tested at Swedish

KOMO News has posted a story on the recent premarket approval by the Food & Drug Administration of a device designed to detect and treat epilepsy.

The story quotes Ryder Gwinn, M.D., medical director of the Swedish Neurosciences Institute Center for Neuromodulation and Functional Restoration

Testing on the NeuroPace device began in 2004 and was conducted throughout the United States, including the Swedish Neuroscience Institute. Today, Swedish is the only center in the Pacific Northwest approved to implant the device.

Read the full story on KOMOnews.com.

Seizure Device Evaluated at Swedish Receives FDA Pre-Market Approval

FOR IMMEDIATE RELEASE: Nov. 21, 2013   

Contacts: Clay Holtzman, Swedish, 206-386-2748, clay.holtzman@swedish.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.

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