Brio™ Rechargeable IPG

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Brio™ Rechargeable IPG
Brio.jpg
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 [4][5]
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

https://www.sjmglobal.com/en-int/professionals/featured-products/neuromodulation/deep-brain-stimulation/implantable-pulse-generators/brio-ipg?halert=show&clset=92f57278-460e-4300-b7fe-89e52a04194f%3acadddb93-fcc4-47f2-8ceb-fd88f01ca17f

http://www.medicalnewstoday.com/articles/295376.php?trendmd-shared=0

https://www.gov.uk/drug-device-alerts/medical-device-alert-implantable-pulse-generators-ipgs-neurostimulators-confirm-actions-from-field-safety-notice

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.

Main characteristics

DBS systems operate open-loop[8]

Purpose

Company & People

Important Dates

  • 1976 - the company St. Jude Medical, Inc. was founded in St. Paul Minnesota.[9]
  • 2009 - Brio™ Rechargeable IPG received CE (Conformité Européenne) mark of approval for treatment of Parkinson disease.[10]
  • 2010 - Brio™ Rechargeable IPG was approved by the Australian Therapeutic Goods Administration (TGA).[11]
  • 2013 - Brio™ Rechargeable IPG received CE (Conformité Européenne) mark of approval for treatment of Dystonia symptoms.[12]
  • 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. 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).
  2. 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. 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).
  4. 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).
  5. 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. 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. 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. 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).
  9. 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).
  10. 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).
  11. 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).
  12. 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).