Difference between revisions of "RNS® System"
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| − | * RNS Neurostimulator, which is a responsive electrical stimulation medical devices (battery powered and microprocessor controlled) <ref name="NeuropaceSystemUserManual"/>. Responsive electrical stimulation is a new approach to treating epilepsy and RNS System is the first device to provide it. | + | * RNS Neurostimulator, which is a responsive electrical stimulation medical devices (battery powered and microprocessor controlled) <ref name="NeuropaceSystemUserManual"/>. Responsive electrical stimulation is a new approach to treating epilepsy and RNS System is the first device to provide it. <ref name="epilepsyResponsiveNeurostimulation>SIRVEN, J.I. Responsive Neurostimulation. Epilepsy Foundation [online]. 2014, May. Available online at: http://www.epilepsy.com/learn/treating-seizures-and-epilepsy/devices/responsive-neurostimulation (Retrieved 4.11.2016)</ref>. RNS Neurostimulator indicates and records certain patterns in the brain (electrocoticographic, ECoG patterns), which caused seizures. Then delivers short trains of current pulses through the leads to interrupt those patterns. Each stimulation can contain two bursts. Neurstimulator must be implanted in the skull together with leads.<ref name="NeuropaceSystemUserManual"/> The Neurostimulator should work for about 2 to 3.5 years before battery power is drained. (http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100026C.pdf) |
* NeuroPace Leads are placed in the brain and are connected to Neurostimulator. One lead contains four electrodes. There are two kind of these leads. First, the Cortical Strip Leads are intended for subdural implant and are available in 15, 25 or 35 centimenters length. Four electrodes in leads are spaced 10 millimenters apart from each other. Second, the Depth Leads are intended for implant into brain. They are in four combinations - 30 centimeter length, 10 millimeter electrode spacing; 30 centimeter length, 3.5 millimeter electrode spacing; 44 centimeter length, 10 millimeter electrode spacing or 44 centimeter length, 3.5 millimeter electrode spacing.<ref name="NeuropaceSystemUserManual"/> | * NeuroPace Leads are placed in the brain and are connected to Neurostimulator. One lead contains four electrodes. There are two kind of these leads. First, the Cortical Strip Leads are intended for subdural implant and are available in 15, 25 or 35 centimenters length. Four electrodes in leads are spaced 10 millimenters apart from each other. Second, the Depth Leads are intended for implant into brain. They are in four combinations - 30 centimeter length, 10 millimeter electrode spacing; 30 centimeter length, 3.5 millimeter electrode spacing; 44 centimeter length, 10 millimeter electrode spacing or 44 centimeter length, 3.5 millimeter electrode spacing.<ref name="NeuropaceSystemUserManual"/> | ||
Revision as of 23:09, 4 November 2016
| RNS® System | |
|---|---|
| [[File:###|250px]] | |
| Category | Deep brain stimulation |
| Developer | NeuroPace, Inc. Mountain View, California [1] |
| Announced | December, 2009 [2][3] |
| Released | Developers:
Consumers: 2013 |
| Price | 35,000 USD (estimated)[4] |
| Max output | 11.5 mA11.5 T 0.0115 A ± 10%, at 500 Ohms; [5] |
| Session duration | 55 s 0.0833 minute (min 10 msec)[5] |
| Scalp location | no settled location (in parietal skull upon recommendation) [5] |
| Weight | 18 g [5] |
| Controls |
laptop personal computer, magnet, NeuroPace Patient Data Management System, NeuroPace Programmer [5] |
| Data available | good |
| Risk factor | |
| Medical prescription | yes |
| http://www.neuropace.com/ | |
RNS® System is medical device for epilepsy treatment.[6] It can monitor and stimulate brain activity, for it is deep brain stimulation device. It is manufactured by privately held company named NeuroPace, which is located in Montain View, California.[7] Therapy with RNS System consist in reducing the frequency of seizures in individuals[5], who have partial-onset, medically refractory (drug resistant) epilepsy.[8] Those patients are treated with RNS System, when they have no more than two epileptogenic foci (epileptogenic focus is the source or starting point of seizures) and are resistant to more than two antiepileptic medications. The RNS System is thus only for medical prescription.
Contents
Main characteristics
The RNS Neurostimulator monitors electrical activity in the brain via the implanted patient leads and delivers therapy in the form of electrical stimulation, when the seizures begin.
Plain device consist of:
- RNS Neurostimulator, which is a responsive electrical stimulation medical devices (battery powered and microprocessor controlled) [5]. Responsive electrical stimulation is a new approach to treating epilepsy and RNS System is the first device to provide it. [9]. RNS Neurostimulator indicates and records certain patterns in the brain (electrocoticographic, ECoG patterns), which caused seizures. Then delivers short trains of current pulses through the leads to interrupt those patterns. Each stimulation can contain two bursts. Neurstimulator must be implanted in the skull together with leads.[5] The Neurostimulator should work for about 2 to 3.5 years before battery power is drained. (http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100026C.pdf)
- NeuroPace Leads are placed in the brain and are connected to Neurostimulator. One lead contains four electrodes. There are two kind of these leads. First, the Cortical Strip Leads are intended for subdural implant and are available in 15, 25 or 35 centimenters length. Four electrodes in leads are spaced 10 millimenters apart from each other. Second, the Depth Leads are intended for implant into brain. They are in four combinations - 30 centimeter length, 10 millimeter electrode spacing; 30 centimeter length, 3.5 millimeter electrode spacing; 44 centimeter length, 10 millimeter electrode spacing or 44 centimeter length, 3.5 millimeter electrode spacing.[5]
- NeuroPace components and accessories contain several devices, for example cranial prosthesis or magnet, which might be used as suppressor of therapy or starter an electrocorticogram storage (records ECoG patterns), if it is placed over the implanted RNS Neurostimulator.[5]
Patients also receive:
- NeuroPace Programmer, which contain a laptop personal computer with software developed by NeuroPace. It prescribe how the neurostimulator operates. Programmer might sets up recording ECoG patterns, perform detection analysis or communicate with NeuroPace Patient Data Management System (PDMS) via the Internet.[5]
- Telemetry Wand permits communication with the programmer via a USB cable.[5]
- NeuroPace Patient Data Management System (PDMS) contains obtained data from patient, who has access via the Internet. User must be authorized for using this system.[5]
Purpose
Company & People
Important Dates
Enhancement/Therapy/Treatment
Ethical & Health Issues
Public & Media Impact and Presentation
Public Policy
Related Technologies, Projects or Scientific Research
References
- ↑ Company Overview. NeuroPace, Inc. [online]. © 2016. Available online at: http://www.neuropace.com/about-us-corporate/ (Retrieved 4.11.2016)
- ↑ NOVELLI, P. NeuroPace announces clinical trial results demonstrating the RNS System. News medical life sciences [online]. 2009, Dec 9. Available online at: http://www.news-medical.net/news/20091209/NeuroPace-announces-clinical-trial-results-demonstrating-the-RNS-System.aspx (Retrieved 4.11.2016)
- ↑ Pivotal Trial Data Demonstrate NeuroPace RNS® System Reduced Seizures in People with Epilepsy. NeuroPace, Inc. [online]. © 2016. Available online at: http://www.neuropace.com/pivotal-trial-data-demonstrate-neuropace/ (Retrieved 4.11.2016)
- ↑ TRINIDAD, T. Keck Medicine physicians first to implant epilepsy-controlling device. USC News [online]. 2013, Dec 19. Available online at: https://news.usc.edu/57947/keck-medicine-physicians-become-first-to-implant-epilepsy-controlling-device/ (Retrieved 4.11.2016)
- ↑ 5.00 5.01 5.02 5.03 5.04 5.05 5.06 5.07 5.08 5.09 5.10 5.11 5.12 RNS® System User Manual. NeuroPace, Inc [online]. © 2016. Available online at: http://www.neuropace.com/wp-content/uploads/2016/08/RNS_System_User_Manual.pdf (Retrieved 4.11.2016)
- ↑ About the technology. NeuroPace, Inc. [online]. © 2016. Available online at: http://www.neuropace.com/the-rns-system/ (Retrieved 4.11.2016)
- ↑ NeuroPace RNS® System Honored With Prestigious Award At The 22nd Annual Phoenix Conference. Business Wire: A Berkshire Hathaway Company [online]. 2015, Nov 4. Available online at: http://www.businesswire.com/news/home/20151104005381/en/NeuroPace-RNS%C2%AE-System-Honored-Prestigious-Award-22nd (Retrieved 4.11.2016)
- ↑ THOMAS, G.P., JOBST, B.C. Critical review of the responsive neurostimulator system for epilepsy. The National Center for Biotechnology Information [online]. 2015, Oct 1. Available online at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4598207/ (Retrieved 4.11.2016)
- ↑ SIRVEN, J.I. Responsive Neurostimulation. Epilepsy Foundation [online]. 2014, May. Available online at: http://www.epilepsy.com/learn/treating-seizures-and-epilepsy/devices/responsive-neurostimulation (Retrieved 4.11.2016)
