NeuroPace to submit PMA application to FDA based on positive trial results
NeuroPace, Inc. today announced that results from its pivotal trial demonstrated the RNS- System, a novel investigational device that utilizes responsive brain neurostimulation, significantly reduced the frequency of seizures among people who have a common form of epilepsy that is difficult to treat with medication. The pivotal trial data, which were presented at the American Epilepsy Society's (AES) 63rd Annual Meeting today, included 191 people with medically intractable partial onset epilepsy enrolled at 31 sites located in the United States.
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. 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.
"For people who cannot control their seizures effectively with medication, the data show the RNS System may be a safe and effective treatment option," said Martha Morrell, MD, Chief Medical Officer of NeuroPace, Inc. and Clinical Professor of Neurology at Stanford University. "The results also indicate the device became even more effective over time. 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 neurostimulation in controlling seizures."