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RNS® System

59 bytes added, 20:09, 6 December 2016
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== 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>
The RNS System is on the other hand based on closed-loop stimulation, which provide stimulation only if triggered by early seizure activity. However the above meantioned systems of stimulation provide stimulation constantly, regardless of neuronal activity. So the RNS System has less adverse effect than the rest.<ref name="Neurostimulation for the Treatment of Epilepsy"/>
There are also some similar devices, that treat the different kind of diseases. One of them is, for example the Activa Deep Brain Stimulation Therapy System (Medtronic), which is targget to treat tremor associated with Parkinson´s disease and essential tremor. It was approved by FDA in 1997.<ref name=" FDA Okays Brio">JEFFREY, S. FDA Okays Brio Neurostimulation System for PD, ET. Medscape [online]. 2015, Jun 12. Available online at: http://www.medscape.com/viewarticle/846456 (Retrieved 3.12.2016)</ref> Similar device for reducing the symptoms of Parkinson's disease is the Brio Neurostimulation System, which was approved by FDA in 2015.<ref name="FDA approves brain implant to help reduce Parkinson’s disease">FDA U.S. Food & Drug Administration. FDA approves brain implant to help reduce Parkinson’s disease and essential tremor symptoms. FDA U.S. Food & Drug Administration: FDA News Release [online]. 2015, Jun 12. Available online at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm451152.htm (Retrieved 3.12.2016)</ref>
== References ==
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