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The implanted devices also might negatively interact with another medical procedures, such as Computed Tomography or MR (magnetic resonance).<ref name="NeuropaceSystemPatientManual"/> It might also cause allergic reaction, skin erosion (around the Neurostimulator), lead migration (move from their desired implant location) etc. There always remains a risk of failure the RNS devices.<ref name="NeuropaceSystemPatientManual"/>
Serious risk might also come from unknown effect of long-term brain stimulation.<ref name="NeuropaceSystemPatientManual"/> This conclusion supports as well the study conducted by Loring, Kapur, Meador and Morrell.<ref name="Differential neuropsychological outcomes following targeted responsive neurostimulation for partial-onset epilepsy">LORING, D.W., KAPUR, R., MEADOR, K.J., MORRELL, M.J. Differential neuropsychological outcomes following targeted responsive neurostimulation for partial-onset epilepsy. Epilepsia [online], 2015, Vol. 56, No. 11, pp. 1836–1844. Available online at: http://onlinelibrary.wiley.com/doi/10.1111/epi.13191/epdf (Retrieved 6.11.2016).</ref> It is probably too soon to determine exact effect of the brain stimulation. The study for long time effect of the brain stimulation is still under way and the estimated completion date is May 2023. <ref name="RNS® System Epilepsy PAS">RNS® System Epilepsy PAS. ClinicalTrials.gov [online]. 2016, Sep. Available online at: https://clinicaltrials.gov/ct2/show/results/NCT02403843 (Retrieved 6.11.2016).</ref>
* Benefits
For example Ian Olsen, who suffers from epilepsy since 11 years old, says about RNS System this: ''After dealing with seizures for 16 years, I feel like I have now defeated my seizures once and for all. The RNS system is helping more and more people with epilepsy – and everyone battling seizures should know about it.''<ref name="NeuroPace_stories">NeuroPace. Ian’s Story. NeuroPace, Inc. [online]. © 2016. Available online at: http://www.neuropace.com/ians-story/ (Retrieved 30.11.2016).</ref>
Now is also especially necessary to establish exactly which role the RNS System will play in treatment of epilepsy. In fact, the RNS System is still at the beginning and it is perceived more like alternative to AED (antiepileptic drug) or surgery. <ref name="AES_ResponsiveNeurostimulation_and_Cognition"/> There remains a question how will look the RNS System in the future. Frank Fischer note that:
''It’s totally logical to me that any neurological condition that results in changes in brain state, where the brain state, by monitoring the brain state that can be determined and then treated by virtue of the delivery of stimulation, may well be able to be treated by virtue of this technology.''<ref name="NeuroPace: Controlling Epilepsy With a Brain Implant"/>
== Public Policy ==
The RNS System was approved (Premarket Approval, PMA) by Food and Drug Administration (FDA) in 2013 based on clinical studies. Those contain a Feasibility study, a Pivotal study, and a Long-term Treatment study. There were also several studies in laboratory, where were tested every single device of the RNS System. Before human studies, there were also studies on animals, particularly on sheep. The Feasibility study contained 65 subjects and was aimed at preliminary safety and effectiveness. The results of the Feasibility study was used in the Pivotal study, which was performed ''"to establish a reasonable assurance of safety and effectiveness of the RNS System"''. It was containing 191 subjects in total. The Long-term Treatment study is still ongoing. It contains 230 subjects. <ref name="SSFD">U.S. Food & Drug Administration. Summary of Safety and Effectiveness Data (SSED). U.S. Food & Drug Administration [online]. 2013. Available online at: http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100026B.pdf (Retrieved 4.11.2016).</ref>
The RNS System devices are connected with several patents. On the website of the NeuroPace company, there are list of the patents for every single device of RNS System: NeuroPace® RNS® Neurostimulator, NeuroPace® Depth Lead, NeuroPace® Cortical Strip Lead, NeuroPace® Programmer, NeuroPace® Remote Monitor, Wand and Ferrule.<ref name="NeuroPace_patents">NeuroPace. Legal Terms. NeuroPace, Inc. [online]. © 2016. Available online at: http://www.neuropace.com/legal/ (Retrieved 30.11.2016).</ref>
