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Ethical & Health Issues
== Important Dates ==
* May 2023 - The completion of study for long time effect of the brain stimulation
* November 14, 2013 - FDA Premarket Approval for the NeuroPace® RNS® System<ref name="FDA Grants Premarket Approval">U.S. Food and Drug Administration. FDA Grants Premarket Approval (PMA) for the NeuroPace® RNS® System to treat Medically Refractory Epilepsy. NeuroPace [online]. 2013, Nov. Available online at: http://www.neuropace.com/wp-content/uploads/2015/11/NeuroPace_Press_Release_PMA_Approval_2013-11-14.pdf(Retrieved 6.11.2016</ref>
* January 19, 2004 - the first patient of the Feasibility Study<ref name="SSFD"/>
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 remain a risk of failure the RNS devices.<ref name="NeuropaceSystemPatientManual"/>
Serious risk might also come out from unknown effect of long-term brain stimulation.<ref name="NeuropaceSystemPatientManual"/> This conclusion support as well 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. Wiley Online Library [online]. 2015. 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
