Seizure Device Evaluated at Swedish Receives FDA Pre-Market Approval
November 21, 2013
By Swedish News
FOR IMMEDIATE RELEASE: Nov. 21, 2013
Contacts: Clay Holtzman, Swedish, 206-386-2748, email@example.com
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.
“We have been working with NeuroPace on the RNS System for about 10 years – ever since I was an Epilepsy Surgery fellow at Yale University. One of the primary reasons I found out about Swedish Medical Center was because the decision of the Swedish Epilepsy Center to participate in the feasibility trial in 2004,” Gwinn said. “Seeing this come to fruition as a therapy we can now use in our hard to treat Epilepsy patients is incredibly meaningful.”
Unlike other stimulation therapies - such as deep brain stimulation (DBS) - which involves scheduled intervals of stimulation, the RNS System continuously monitors brain electrical activity to detect and respond to abnormal electrical activity.
“We’ve seen really positive outcomes in some of our hardest to treat Epilepsy patients,” said Swedish Epilepsy physician Michael Doherty M.D., FAAN.
Swedish Health Services makes significant contributions to medical research every day, participating in more than 700 projects each year. Swedish physicians and researchers collaborate with other scientists from across the U.S. and around the world. Over than last decade, nearly $70 million worth of private and federal research has been conducted at Swedish.
To learn more about the NeuroPace® RNS® System, visit the NeuroPace website at http://www.neuropace.com/.
About Swedish Neuroscience Institute
Swedish Neuroscience Institute (SNI) provides advanced, progressive treatment for a wide range of brain, spine and central nervous system conditions. SNI is committed to ensuring quality outcomes by acquiring the most advanced technology and participating in leading-edge research. Read more at: http://www.swedish.org/Services/Neuroscience-Institute
Swedish has grown over the last 103 years to become the largest non-profit health provider in the Greater Seattle area. It is comprised of five hospital campuses (First Hill, Cherry Hill, Ballard, Edmonds and Issaquah); ambulatory care centers in Redmond and Mill Creek; and Swedish Medical Group, a network of more than 100 primary care and specialty clinics located throughout the Greater Puget Sound area. In addition to general medical and surgical care including robotic-assisted surgery, Swedish is known as a regional referral center, providing specialized treatment in areas such as cardiovascular care, cancer care, neuroscience, orthopedics, high-risk obstetrics, pediatric specialties, organ transplantation and clinical research. In 2012, Swedish provided more than $130 million in community benefit in Western Washington. For more information, visit www.swedish.org, www.swedishcares.org, www.facebook.com/swedishmedicalcenter, or www.twitter.com/swedish.