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. Physicians at the SNI Epilepsy Center implanted the first device in humans in 2004, and now have more experience than any other center participating in the trial, which included 32 centers across the United States.
The SNI Epilepsy Center will be the only center in the Pacific Northwest implanting the device as it is released for general use. The RNS device is the most sophisticated ever implanted in humans, and has the ability to both listen to brain activity on an ongoing basis and then intervene with a therapeutic stimulation to the site of seizure onset, aborting a seizure before it becomes clinically noticeable. I invite you to learn more about the Swedish Neuroscience Epilepsy Center here. For more information about the RNS device and its premarket approval by the FDA, visit www.neuropace.com.
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