Infection and Erosion Rates in Patients Implanted with the RNS System
Abstract number :
3.23
Submission category :
4. Clinical Epilepsy / 4C. Clinical Treatments
Year :
2022
Submission ID :
2205007
Source :
www.aesnet.org
Presentation date :
12/5/2022 12:00:00 PM
Published date :
Nov 22, 2022, 05:27 AM
Authors :
Natalie Schmidt, FNP-BC – NeuroPace Inc; Felicia Elefant, BS – NeuroPace Inc; Tracy Courtney, BS – NeuroPace Inc; Martha Morrell, MD – NeuroPace Inc
Rationale: The NeuroPace RNS® System was approved by the FDA in November 2013 to treat medically refractory focal epilepsy. Prior reports of RNS System safety demonstrated infection rates of 3.7% and erosion rates of 0.8% per procedure.1 Here we provide updated data regarding infections and erosions collected since the FDA approval of the RNS System.
Methods; All reports of RNS System serious adverse events (SAEs) submitted to NeuroPace between 1/1/2014 and 5/4/2022 were retrospectively reviewed for reports of infections and erosions. The data set included serious adverse events collected as part of NeuroPace-sponsored clinical trials, as well as post-market surveillance reports voluntarily reported by treating facilities and reported by NeuroPace to FDA in compliance with the MDR reporting obligations. “Serious adverse events” were classified per the FDA definition. Duplicate events were excluded for both categories. Rates were from total number of surgical procedures, inclusive of initial neurostimulator and/or lead implant, replacement, explant, and revision.
Results: There were a total of 5939 device related surgeries in 3978 patients (average of 1.5 procedures per patient), 3850 initial neurostimulator implants, 124 lead-only procedures 211 explants, 70 re-implants, and 1587 neurostimulator replacements (largely for anticipated end of battery service). Ninety-seven procedures were categorized as “other adjustment.” A total of 177 unique serious infection events and 79 unique erosion events were identified. Infection rates were 3% per surgical procedure (n=177/5939). The most commonly reported serious infections were at the scalp incision. A subset of reports contained the type of organism with staphylococcus (n=24) followed by S. aureus (n=17) being the most common. Erosion rate was 1.3% per neurostimulator procedure (n=79/5939).
Conclusions: These updated numbers show that the infection rate per neurostimulator procedure is similar to but slightly lower than those previously reported.1 Erosion rates are similar to those previously reported._x000D_
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Reference:_x000D_
1. Weber et al Stereotact Funct Neurosurg 2017
Funding: Not applicable
Clinical Epilepsy