NeuroPace, Inc. designs, develops, manufactures, and markets implantable devices for the treatment of neurological disorders with responsive stimulation. The company offers RNS System, a medical device that monitors and responds to brain activity. Its RNS System consists of a small implantable neuro stimulator that is connected to leads that are placed in up to two seizure onset areas. NeuroPace, Inc. was founded in 1997 and is based in Mountain View, California.
455 North Bernardo Avenue
Mountain View, CA 94043
Founded in 1997
NeuroPace, Inc. Announces Results of Long-Term Treatment Study of RNS System
Feb 3 15
NeuroPace, Inc. announced that interim results from its ongoing long-term treatment (LTT) study demonstrate the RNS System significantly reduces seizure frequency among adults who have a common form of epilepsy that is difficult to treat with medication. Results of the ongoing LTT study include data on 230 people with medically intractable partial onset epilepsy enrolled at 33 Comprehensive Epilepsy Centers in the United States. The median reduction in seizure frequency compared to patients’ pre-implant seizure frequency was 60% at the beginning of the third year post-implant and 66% at the beginning of the sixth year. The LTT study is an ongoing seven-year, multi-center prospective open-label study for participants who previously completed a feasibility or randomized controlled trial of the RNS System. 97% of these patients elected to continue treatment and participate in the LTT study. The median reduction in seizure frequency in the pivotal study was 44% at one year and 53% at two years, and ranged up to 66% over post-implant years three through six in the LTT study. Furthermore, 23% of patients experienced at least one six month period free of seizures. For comparison, these patients had to average at least three seizures per month in order to enroll in the original trial. The study also demonstrated significant improvements in overall quality of life and indicates a more positive perception of cognitive function, relationships and social function, overall health, and vulnerability to seizures. There were no serious unanticipated device related adverse events in the trial and responsive neurostimulation was well-tolerated and safe over time. As a closed-loop system, the RNS System monitors the brain’s own signals, interprets those signals, provides stimulation when needed, and then assesses the brain’s response. The breakthrough aspect of the RNS System is its advanced detection and stimulation capabilities. This is unlike all other existing neurostimulation therapies, which continuously or intermittently stimulate the brain without determining the need for treatment or monitoring the response. The RNS System has been evaluated in three clinical trials, including a prospective, randomized, double-blinded, sham stimulation controlled pivotal study and the LTT study. Results of the clinical trials demonstrate that the substantial clinical improvements experienced by patients over the short- and long-term are meaningful and durable over many years of therapy. At this time, some patients have been treated with the RNS System for more than 11 years, and more than 1,500 patient years of experience with responsive neurostimulation have been accumulated to date.