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New Brain Stimulator Approved to Treat Epilepsy

On November 14th, 2013 the FDA gave its approval for an implanted brain stimulator to treat patients with medically refractory epilepsy. Epilepsy is one of the most common neurological disorders affecting nearly 1 in 100 Americans. This device has been under investigation for 10 years at the Swedish Neuroscience Institute (SNI) Epilepsy Center.

As principal investigator for the trial, I led  a team including Dr. Michael Doherty, Dr. Lisa Caylor and Dr. Alan Haltiner, along with the research department at Swedish to investigate the safety and effectiveness of the device through pivotal trials. The results showed that the responsive neurostimulator system (RNS) made by NeuroPace was indeed effective in treating patients with drug resistant seizures.

Why is this so significant? This device represents the first new non-medication treatment for seizures proven to be effective since 1997, and gives new hope to patients whose lives have been put on hold due to seizures. ...

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.

SNI Grand Round Series 2011 - Epilepsy Genetics

Thursday, February 3, 2011
7:30am - 8:30am
Swedish Education Conference Center, Room B

Marcio Sotero de Menezes, MD, Pediatric Epilepsy, Pediatric Neurology, Swedish Neuroscience Institute

Objectives:

At the conclusion of this session, attendees will have an increased ability to:

  • Identify genetic epilepsy syndromes
  • Explain treatment of genetic epilepsy syndromes

SNI Grand Round Series is every 1st and 3rd Thursday of each month.

New center brings tertiary neurological care to children

The Pediatric Epilepsy and Pediatric Neurology services at Swedish Medical Center have combined to create the new Swedish Pediatric Neuroscience Center. As part of the Swedish Neuroscience Institute (SNI), comprehensive neurological care for newborns, infants, children and adoles­cents is now located at the Swedish First Hill campus in Seattle. Marcio Sotero de Menezes, M.D., has been appointed direc­tor of the new center.

The center has a high patient volume for the medical and surgical treatment of seizure disorders, including complex epi­lepsy syndromes and genetic epilepsies. It is accredited by the National Association of Epilepsy Centers as a Level-4 epilepsy center.

In addition to epilepsy, the center’s specialists treat pediatric patients for a wide range of neurological disorders, in­cluding headache and migraine; move­ment disorders, tics and Tourette’s syn­drome; genetic and metabolic disorders; neurodevelopmental disorders and learn­ing disabilities; brain malformations; cere­bral palsy; stroke; tuberous sclerosis; and neurofibromatosis.

The center’s pa­tients will also benefit from a broad spectrum of pediatric neurol­ogy inpatient hospital services, including epilepsy monitoring unit, pediatric and neonatal intensive care units, procedural seda­tion services, pediatric neurosurgery and intraoperative EEG monitoring, imaging services, and neuropsychological testing. Physical, occupational and speech therapy services are also available to the center’s patients.

For more information about the Swedish Pediatric Neuroscience Center, please call 206-215-1440.

Swedish Neuroscience Institute Clinical Neurophysiology Lab Receives Accreditation; First and Only Lab in Washington State, One of Only 10 West of Mississippi to Receive Honor

Clinical Neurophysiology Lab Receives Accreditation

Congratulations are in order for the Clinical Neurophysiology Laboratory for attaining Accreditation by the EEG Laboratory Accreditation board of ABRET. We are the first and only Lab to receive Accreditation in Washington State and one of only 10 labs west of the Mississippi. Accreditation means the Lab has met strict standards and is recognized as a place where patients and physicians can have confidence they are receiving quality diagnostics. Thanks for all the great work and CONGRATULATIONS to everyone on the team who made this possible!

-Colleen Douville

Director for Cerebrovascular Ultrasound
Program Manager for Clinical Neurophysiology

The neurophysiology laboratory at Swedish is a critical component to the Epilepsy program.

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