Brian Sullivan



Responsive Neuro-stimulation (RNS) systems help control symptoms in patients suffering from severe epilepsy according to a study released at the American Epilepsy Society 63rd Annual Meeting in Boston.
Medtronic and NeuroPace announced that RNS reduced the frequency of seizures in a trial of 191 people with medically intractable partial onset epilepsy.
The RNS System is designed to continuously monitor brain electrical activity and, after identifying a patient's unique "signature" indicating a seizure is starting, deliver brief and mild electrical stimulations with the intention of suppressing the seizure.
The trial demonstrated a statistically significant 29 percent in seizures compared to 14 percent reduction in a placebo group.
Long term use demonstrated that after 12 weeks 47 percent of 171 study participants had a 50 percent or greater reduction in their seizure frequency.
This showed that the RNS System may be a safe and effective treatment option for people who cannot control effectively their seizures with medication, said Chief Medical Officer of NeuroPace Martha Morrell.
"The results also indicate the device became even more effective over time” said Morell who is also and Clinical Professor of Neurology at Stanford University.
“These findings, drawn from a data set that includes people living with the most difficult type of epilepsy to manage, truly speak to the potential of responsive neuro-stimulation in controlling seizures."


The RNS System differs from deep brain stimulation, which delivers stimulation continuously or on a pre-set schedule.
It gives physicians the ability to non-invasively program the detection and stimulation parameters of an implanted RNS Neurostimulator specifically for individual patients.
The serious adverse event rate less than comparative surgical procedures and no serious unanticipated device related adverse events reported.
Adverse events including depression, memory impairment and anxiety were the same for treatment and placebo groups.
Epilepsy effects 50 million people worldwide according to the World Health Organization (WHO).

NeuroPace plans to submit a premarket approval (PMA) application to the U.S. Food & Drug Administration (FDA) in early 2010 seeking approval of the RNS System for the treatment of epilepsy



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