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Abstract Details

Interim Safety and Effectiveness Outcomes from a Prospective Post-Approval Trial of the RNS® System
Epilepsy/Clinical Neurophysiology (EEG)
P12 - Poster Session 12 (12:00 PM-1:00 PM)
12-008
This study reports the first year outcomes from a 5-year prospective open-label post-approval study (PAS) conducted at 30 sites.
The RNS® System (NeuroPace, Inc.) is an FDA-approved brain-responsive neurostimulation system for adjunctive treatment of adults with focal onset seizures.  
Adults with medically intractable focal onset seizures localized to 1 or 2 seizure foci were enrolled. Efficacy assessments included median % change in seizure frequency and responder rate (RR, % of subjects with ≥ 50% seizure reduction). Safety was assessed by reporting of adverse events.
As of 04/01/2019, 191 adults were enrolled and treated. Mean age was 36.7 years, mean epilepsy duration was16.9 years, and median baseline seizure frequency was 5.7 seizures/month. Mean follow-up was 1.4 years with a cumulative 265 patient implant years. 128 patients had ≥ one year follow-up and were included in efficacy analyses. The median % reduction was 68% (IQR: 16.1 to 96.0%) and responder rate was 61% (95% CI: 52.3-69.0%). In addition, 34.4% of patients experienced ≥ 6-months without seizures, and 42.2% experienced ≥ 90% reduction in seizure frequency in their most recent 6 months. There were no unanticipated device-related serious adverse events (SAEs). Four patients had SAEs related to intracranial hemorrhage that were not attributed to seizure-related head trauma. The rate of infection was 2.0% per procedure, and all were soft tissue only.
The median % reduction in seizure frequency at 1 year in the PAS appears to be higher than the reductions observed at a similar time point in the initial randomized controlled (Pivotal) trial of the RNS System (44%). The safety experience in the PAS appears to be consistent with the experience reported in the Pivotal study. This early prospective post-approval study experience continues to support the safety and effectiveness of treatment of medically intractable focal seizures with the RNS System. 
Authors/Disclosures
HaeWon Shin, MD (University of Tennessee Health Science Center)
PRESENTER 		The institution of Dr. Shin has received research support from NIH RO1. The institution of Dr. Shin has received research support from NIH U Grant. The institution of Dr. Shin has received research support from UCB. The institution of Dr. Shin has received research support from Biogen. The institution of Dr. Shin has received research support from Neuropace. The institution of Dr. Shin has received research support from Praxis Precision Medicine.
Martha Morrell, MD, FÂ鶹´«Ã½Ó³»­ (NeuroPace/Stanford University) Dr. Morrell has received personal compensation for serving as an employee of NeuroPace. Dr. Morrell has or had stock in NeuroPace. The institution of Dr. Morrell has received research support from National Institutes of Health.