Difference between revisions of "Brio™ Rechargeable IPG"
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max_session_duration=0.05| | max_session_duration=0.05| | ||
max_session_duration_commentary=s<ref name="manual"/>| | max_session_duration_commentary=s<ref name="manual"/>| | ||
| − | scalp_location=subthalamic nucleus, globus pallidus internus| | + | scalp_location=subthalamic nucleus, globus pallidus internus, ventral intermediate nucleus| |
| − | scalp_location_commentary=<ref>OKUN, M. et al. Subthalamic deep brain stimulation with a constant-current device in Parkinson's disease: an open-label randomised controlled trial. The Lancet Neurology, 2012, 11(2), 140-149. Available online at: http://www.sciencedirect.com/science/article/pii/S1474442211703088 (Retrieved 6th April, 2017).</ref><ref name="switching">PREDA, F. et al. Switching from constant voltage to constant current in deep brain stimulation: a multicenter experience of mixed implants for movement disorders. European Journal of Neurology, 2016, 23(1), 190–195. Doi:10.1111/ene.12835 Available online at: http://onlinelibrary.wiley.com/doi/10.1111/ene.12835/full (Retrieved 6th April, 2017).</ref>| | + | scalp_location_commentary=<ref>OKUN, M. et al. Subthalamic deep brain stimulation with a constant-current device in Parkinson's disease: an open-label randomised controlled trial. The Lancet Neurology, 2012, 11(2), 140-149. Available online at: http://www.sciencedirect.com/science/article/pii/S1474442211703088 (Retrieved 6th April, 2017).</ref><ref name="switching">PREDA, F. et al. Switching from constant voltage to constant current in deep brain stimulation: a multicenter experience of mixed implants for movement disorders. European Journal of Neurology, 2016, 23(1), 190–195. Doi:10.1111/ene.12835 Available online at: http://onlinelibrary.wiley.com/doi/10.1111/ene.12835/full (Retrieved 6th April, 2017).</ref><ref name="programmer"/>| |
weight=29| | weight=29| | ||
weight_commentary=<ref name="Newswise">St. Jude Medical. St. Jude Medical Receives CE Mark Approval for World’s Smallest, Longest-Lasting Rechargeable Deep Brain Stimulator for Parkinson’s Disease. Newswise, Inc [online]. 2009, Sep 9. Available online at: http://www.newswise.com/articles/st-jude-medical-receives-ce-mark-approval-for-world-s-smallest-longest-lasting-rechargeable-deep-brain-stimulator-for-parkinson-s-disease-first-patient-implanted-with-brio-neurostimulator-at-university-of-cologne-germany32 (Retrieved 6th April, 2017).</ref>| | weight_commentary=<ref name="Newswise">St. Jude Medical. St. Jude Medical Receives CE Mark Approval for World’s Smallest, Longest-Lasting Rechargeable Deep Brain Stimulator for Parkinson’s Disease. Newswise, Inc [online]. 2009, Sep 9. Available online at: http://www.newswise.com/articles/st-jude-medical-receives-ce-mark-approval-for-world-s-smallest-longest-lasting-rechargeable-deep-brain-stimulator-for-parkinson-s-disease-first-patient-implanted-with-brio-neurostimulator-at-university-of-cologne-germany32 (Retrieved 6th April, 2017).</ref>| | ||
controls1=Brio™ Patient Programmer| | controls1=Brio™ Patient Programmer| | ||
| − | controls_commentary=<ref>St. Jude Medical. Brio™ Patient Programmer. U.S. Food and Drug Administration [online]. Available online at: www.accessdata.fda.gov/cdrh_docs/pdf14/P140009c.pdf (Retrieved 6th April, 2017).</ref>| | + | controls_commentary=<ref name="programmer">St. Jude Medical. Brio™ Patient Programmer. U.S. Food and Drug Administration [online]. Available online at: www.accessdata.fda.gov/cdrh_docs/pdf14/P140009c.pdf (Retrieved 6th April, 2017).</ref>| |
data_available=| | data_available=| | ||
risk_factor=| | risk_factor=| | ||
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== Main characteristics == | == Main characteristics == | ||
| − | + | Brio™ Rechargeable IPG was developed as a medical device which could provide treatment through [[Deep brain stimulation|deep brain stimulation]]. It is a standalone device and could be received only on prescription. It has to be implanted only on special clinics and the quality of surgery has a huge impact on the results of the device.<ref name="programmer"/> The device was approved by as a treatment of symptoms of Parkinson disease, essential tremor,<ref name="business"/> and Dystonia.<ref name="dystonia"/> | |
| − | |||
Hardware | Hardware | ||
| Line 56: | Line 55: | ||
== Important Dates == | == Important Dates == | ||
* 1976 - the company St. Jude Medical, Inc. was founded in St. Paul Minnesota.<ref name="history of comp.">St. Jude Medical, Inc. Our History: Investing in People and Ideas. St. Jude Medical, Inc. [online]. Available online at: https://www.sjmglobal.com/en-int/about/company-facts/history?clset=92f57278-460e-4300-b7fe-89e52a04194f%3acadddb93-fcc4-47f2-8ceb-fd88f01ca17f (Retrieved 6th April, 2017).</ref> | * 1976 - the company St. Jude Medical, Inc. was founded in St. Paul Minnesota.<ref name="history of comp.">St. Jude Medical, Inc. Our History: Investing in People and Ideas. St. Jude Medical, Inc. [online]. Available online at: https://www.sjmglobal.com/en-int/about/company-facts/history?clset=92f57278-460e-4300-b7fe-89e52a04194f%3acadddb93-fcc4-47f2-8ceb-fd88f01ca17f (Retrieved 6th April, 2017).</ref> | ||
| − | * 2009 - Brio™ Rechargeable IPG received CE (Conformité Européenne) mark of approval for treatment of Parkinson disease.<ref>BUSINESS WIRE. St. Jude Medical Receives CE Mark Approval for World’s Smallest, Longest-Lasting Rechargeable Deep Brain Stimulator for Parkinson’s Disease. BUSINESS WIRE [online]. 2009, Sep 9. Available online at: http://www.businesswire.com/news/home/20090909005095/en/St.-Jude-Medical-Receives-CE-Mark-Approval (Retrieved 6th April, 2017).</ref> | + | * 2009 - Brio™ Rechargeable IPG received CE (Conformité Européenne) mark of approval for treatment of Parkinson disease.<ref name="business">BUSINESS WIRE. St. Jude Medical Receives CE Mark Approval for World’s Smallest, Longest-Lasting Rechargeable Deep Brain Stimulator for Parkinson’s Disease. BUSINESS WIRE [online]. 2009, Sep 9. Available online at: http://www.businesswire.com/news/home/20090909005095/en/St.-Jude-Medical-Receives-CE-Mark-Approval (Retrieved 6th April, 2017).</ref> |
* 2010 - Brio™ Rechargeable IPG was approved by the Australian Therapeutic Goods Administration (TGA).<ref name="Australia">St. Jude Medical. St. Jude Medical's Brio DBS system for treating Parkinson’s disease receives Australian TGA approval. News-Medical.Net [online]. 2010, Mar 23. Available online at: http://www.news-medical.net/news/20100323/St-Jude-Medicals-Brio-DBS-system-for-treating-Parkinsone28099s-disease-receives-Australian-TGA-approval.aspx (Retrieved 6th April, 2017).</ref> | * 2010 - Brio™ Rechargeable IPG was approved by the Australian Therapeutic Goods Administration (TGA).<ref name="Australia">St. Jude Medical. St. Jude Medical's Brio DBS system for treating Parkinson’s disease receives Australian TGA approval. News-Medical.Net [online]. 2010, Mar 23. Available online at: http://www.news-medical.net/news/20100323/St-Jude-Medicals-Brio-DBS-system-for-treating-Parkinsone28099s-disease-receives-Australian-TGA-approval.aspx (Retrieved 6th April, 2017).</ref> | ||
| − | * 2013 - Brio™ Rechargeable IPG received CE (Conformité Européenne) mark of approval for treatment of Dystonia symptoms.<ref>GUILLIOTTI, Kimberly. St Jude Medical’s Deep Brain Stimulation Trifecta: New Treatment Options for Dystonia in EU. MD Buyline [online]. 2013, Apr 23. Available online at: http://www.mdbuyline.com/st-jude-medicals-deep-brain-stimulation-trifecta-new-treatment-options-for-dystonia-in-eu/ (Retrieved 6th April, 2017).</ref> | + | * 2013 - Brio™ Rechargeable IPG received CE (Conformité Européenne) mark of approval for treatment of Dystonia symptoms.<ref name="dystonia">GUILLIOTTI, Kimberly. St Jude Medical’s Deep Brain Stimulation Trifecta: New Treatment Options for Dystonia in EU. MD Buyline [online]. 2013, Apr 23. Available online at: http://www.mdbuyline.com/st-jude-medicals-deep-brain-stimulation-trifecta-new-treatment-options-for-dystonia-in-eu/ (Retrieved 6th April, 2017).</ref> |
* 2015 - Brio™ Rechargeable IPG approved by FDA.<ref name="approval"/> | * 2015 - Brio™ Rechargeable IPG approved by FDA.<ref name="approval"/> | ||
Revision as of 08:13, 7 April 2017
| Brio™ Rechargeable IPG | |
|---|---|
|
|
| Category | Deep brain stimulation |
| Developer | St. Jude Medical, Inc. [1] |
| Announced | 2009 [1] |
| Released | Developers:
Consumers: 2009 [1] |
| Price | 19 150 USD [2] |
| Max output | 12.512.5 T 12.5 mA 0.0125 A mA[3] |
| Session duration | 0.050.05 s 8.333334e-4 minute s[3] |
| Scalp location | subthalamic nucleus, globus pallidus internus, ventral intermediate nucleus [4][5][6] |
| Weight | 29 g [1] |
| Controls |
Brio™ Patient Programmer [6] |
| Data available | |
| Risk factor | |
| Medical prescription | yes |
| https://www.sjmglobal.com/en-int/professionals/featured-products/neuromodulation/deep-brain-stimulation/implantable-pulse-generators/brio-ipg | |
http://www.medicalnewstoday.com/articles/295376.php?trendmd-shared=0
Brio™ Rechargeable IPG (Implantable Pulse Generator) provides deep brain stimulation therapy for patients suffering by Parkinson disease and essential tremor. It does not cure the diseases but it helps to reduce their symptoms. It is used primarily in the cases when the medication of the disease is not successful.[7]
The device was developed by St. Jude Medical, Inc. the company which focus on the medical devices and is settled in St. Paul, Minnesota.[8]
Contents
Main characteristics
Brio™ Rechargeable IPG was developed as a medical device which could provide treatment through deep brain stimulation. It is a standalone device and could be received only on prescription. It has to be implanted only on special clinics and the quality of surgery has a huge impact on the results of the device.[6] The device was approved by as a treatment of symptoms of Parkinson disease, essential tremor,[9] and Dystonia.[10]
Hardware
Software
History
DBS systems operate open-loop[11]
Purpose
Company & People
Important Dates
- 1976 - the company St. Jude Medical, Inc. was founded in St. Paul Minnesota.[12]
- 2009 - Brio™ Rechargeable IPG received CE (Conformité Européenne) mark of approval for treatment of Parkinson disease.[9]
- 2010 - Brio™ Rechargeable IPG was approved by the Australian Therapeutic Goods Administration (TGA).[8]
- 2013 - Brio™ Rechargeable IPG received CE (Conformité Européenne) mark of approval for treatment of Dystonia symptoms.[10]
- 2015 - Brio™ Rechargeable IPG approved by FDA.[7]
Enhancement/Therapy/Treatment
Ethical & Health Issues
http://onlinelibrary.wiley.com/doi/10.1111/ner.12026/full
Public & Media Impact and Presentation
Public Policy
Related Technologies, Projects or Scientific Research
References
- ↑ 1.0 1.1 1.2 1.3 St. Jude Medical. St. Jude Medical Receives CE Mark Approval for World’s Smallest, Longest-Lasting Rechargeable Deep Brain Stimulator for Parkinson’s Disease. Newswise, Inc [online]. 2009, Sep 9. Available online at: http://www.newswise.com/articles/st-jude-medical-receives-ce-mark-approval-for-world-s-smallest-longest-lasting-rechargeable-deep-brain-stimulator-for-parkinson-s-disease-first-patient-implanted-with-brio-neurostimulator-at-university-of-cologne-germany32 (Retrieved 6th April, 2017).
- ↑ Australian Government. Private Health Insurance (Prostheses) Rules 2015 (No. 1). Federal Register of Legislation [online]. Available online at: https://www.legislation.gov.au/Details/F2015C00649/Html/Volume_2 (Retrieved 6th April, 2017).
- ↑ 3.0 3.1 Advanced Neuromodulation Systems, Inc. Brio™ Mozkový neurostimulátor: Manuál pro klinického lékaře. Cardion [online]. Available online at: http://www.cardion.cz/file/190/brio-klinicky-manual.pdf (Retrieved 6th April, 2017).
- ↑ OKUN, M. et al. Subthalamic deep brain stimulation with a constant-current device in Parkinson's disease: an open-label randomised controlled trial. The Lancet Neurology, 2012, 11(2), 140-149. Available online at: http://www.sciencedirect.com/science/article/pii/S1474442211703088 (Retrieved 6th April, 2017).
- ↑ PREDA, F. et al. Switching from constant voltage to constant current in deep brain stimulation: a multicenter experience of mixed implants for movement disorders. European Journal of Neurology, 2016, 23(1), 190–195. Doi:10.1111/ene.12835 Available online at: http://onlinelibrary.wiley.com/doi/10.1111/ene.12835/full (Retrieved 6th April, 2017).
- ↑ 6.0 6.1 6.2 St. Jude Medical. Brio™ Patient Programmer. U.S. Food and Drug Administration [online]. Available online at: www.accessdata.fda.gov/cdrh_docs/pdf14/P140009c.pdf (Retrieved 6th April, 2017).
- ↑ 7.0 7.1 U.S. Food and Drug Administration. FDA approves brain implant to help reduce Parkinson’s disease and essential tremor symptoms. U.S. Food and Drug Administration [online]. 2015, Jun 12. Available online at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm451152.htm (Retrieved 6th April, 2017).
- ↑ 8.0 8.1 St. Jude Medical. St. Jude Medical's Brio DBS system for treating Parkinson’s disease receives Australian TGA approval. News-Medical.Net [online]. 2010, Mar 23. Available online at: http://www.news-medical.net/news/20100323/St-Jude-Medicals-Brio-DBS-system-for-treating-Parkinsone28099s-disease-receives-Australian-TGA-approval.aspx (Retrieved 6th April, 2017).
- ↑ 9.0 9.1 BUSINESS WIRE. St. Jude Medical Receives CE Mark Approval for World’s Smallest, Longest-Lasting Rechargeable Deep Brain Stimulator for Parkinson’s Disease. BUSINESS WIRE [online]. 2009, Sep 9. Available online at: http://www.businesswire.com/news/home/20090909005095/en/St.-Jude-Medical-Receives-CE-Mark-Approval (Retrieved 6th April, 2017).
- ↑ 10.0 10.1 GUILLIOTTI, Kimberly. St Jude Medical’s Deep Brain Stimulation Trifecta: New Treatment Options for Dystonia in EU. MD Buyline [online]. 2013, Apr 23. Available online at: http://www.mdbuyline.com/st-jude-medicals-deep-brain-stimulation-trifecta-new-treatment-options-for-dystonia-in-eu/ (Retrieved 6th April, 2017).
- ↑ PICILLO, Marina, FASANO, Alfonso. Recent advances in Essential Tremor: Surgical treatment. Parkinsonism & Related Disorders, 2016, 22(1), S171–S175. DOI: 10.1016/j.parkreldis.2015.09.012 Available online at: http://www.sciencedirect.com/science/article/pii/S1353802015003879 (Retrieved 6th April, 2017).
- ↑ St. Jude Medical, Inc. Our History: Investing in People and Ideas. St. Jude Medical, Inc. [online]. Available online at: https://www.sjmglobal.com/en-int/about/company-facts/history?clset=92f57278-460e-4300-b7fe-89e52a04194f%3acadddb93-fcc4-47f2-8ceb-fd88f01ca17f (Retrieved 6th April, 2017).
