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List of implantable VAD devices

[edit]

This is a partial list and may never be complete.
Referenced additions are welcome.

Device Manufacturer Type Approval Status as of 2016
Thoratec PVAD (Paracorporeal Ventricular Assist Device)[1] Thoratec First-generation paracorporeal pulsatile biventricular VAD[2][3] Approved for use in Canada in 1994.[4] FDA approval for use in USA for bridge to transplantation in 1995 and for post-cardiotomy recovery in 1998.[4] CE Mark approval for use in Europe in 1998.[4]
Excor Pediatric[5] Berlin Heart Extracorporeal, pulsatile, pneumatically driven, right or left ventricular assist device for children[6] CE Mark approved for use in Europe in 1996.[6] FDA approval for use in USA for bridge to transplantation in 2011.[5]
MicroMed DeBakey VAD MicroMed Second-generation, continuous-flow axial-pump LVAD[3] Approved for use for bridge to transplantation in Europe in 2001.[7] In 2004 the child version was approved by the FDA for use in children in USA as a Humanitarian Device Exemption.[8] The MicroMed DeBakey VAD has been replaced by the ReliantHeart HeartAssist5.[9]
Incor[10][11] Berlin Heart Third-generation, continuous-flow magnetically suspended, axial-pump LVAD[12] CE Mark approved for use in Europe for bridge to transplantation in 2003.[13][12]
HeartMate II[14][15] Thoratec Second-generation continuous-flow axial-pump LVAD[2][3] CE Mark approved for bridge to transplantation and for destination therapy in Europe in 2005.[16] Received FDA approval for bridge-to-transplantation use in 2008, and for destination therapy in 2010.[17][18][19][20]
Jarvik 2000[21][22] Jarvik Heart Second-generation, continuous flow, axial-pump LVAD[2][3] CE Mark approved for use in Europe for both bridge-to-transplant and lifetime use in 2005.[23] Awaiting FDA approval for marketing in USA as a bridge to transplant.[24] Is undergoing FDA clinical trials for destination therapy.[25]
DuraHeart[26] Terumo Third-generation, continuous-flow, magnetically levitated, centrifugal-pump LVAD[2][3] CE Mark approved for marketing in Europe for bridge-to-transplantation in 2007.[26] FDA trials for bridge to transplant terminated due to insufficient enrollment.[27]
HeartWare Ventricular Assist System (with HeartWare HVAD)[28] HeartWare[29] Third-generation, continuous-flow, magnetically levitated, centrifugal-pump LVAD[2][3] CE Mark approval for use in Europe for bridge to transplantation in 2009, and for destination therapy in 2012.[30] FDA approval for use in bridge to transplantation in the U.S. in 2012.[31] In clinical trials for destination therapy.[32]
HeartAssist5[33] ReliantHeart Second-generation, continuous-flow axial-pump LVAD[2][3] CE Mark approved for use in Europe for bridge-to-transplantation and destination therapy in 2013.[34][35][9] Undergoing clinical trials in USA for FDA approval.[36] The pediatric version is approved by the FDA for use in children in USA for bridge to transplantation.[37]
HeartMate 3[38][39] Thoratec Third-generation, continuous-flow, magnetically levitated, axial-pump LVAD[3] CE Mark approved in 2015.[40] USA trials ongoing.[41][42]

Discontinued VAD devices

[edit]
Device Manufacturer Type Notes
Thoratec IVAD (Implantable Ventricular Assist Device)[43][44] Thoratec First-generation implantable pulsatile biventricular VAD[2][3] CE Mark approved for use in Europe in 2003.[4][43] FDA approved for use in USA for bridge to transplantation and for post-cardiotomy recovery in 2004.[4] Approved for use in Canada in 2004.[4] Discontinued in 2015.[45]
Novacor World Heart Pulsatile-flow LVAD[2] Was approved for use in North America, Europe, and Japan. Discontinued in 2007.[46]
HeartMate XVE Thoratec First-generation, pulsatile-flow LVAD[3] FDA approval for bridge to transplantation in 2001 and destination therapy in 2003. CE Mark approved. Discontinued in 2011 after HeartMate II received FDA approval.[47]
VentrAssist Ventracor Third-generation, continuous-flow, centrifugal-pump LVAD[3] Approved for use in Europe and Australia. In 2009 the VentrAssist was discontinued and the company Ventracor was dissolved.[48][49][50]

References

[edit]
  1. ^ Thoratec PVAD. Thoratec.com. Retrieved 23 June 2016.
  2. ^ a b c d e f g h Otto, Catherine M. The Practice of Clinical Echocardiography. Elsevier Health Sciences, 2012. p. 598.
  3. ^ a b c d e f g h i j k Ezon, David. VAD Review. PedsCards.com. Retrieved 23 June 2016.
  4. ^ a b c d e f Thoratec Corp. SEC Filings: 10-K filed February 23, 2011. p. 3.
  5. ^ a b Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD) - H100004. U.S. Food and Drug Administration. Retrieved June 20, 2016.
  6. ^ a b Berlin Heart. EXCOR Pediatric VAD. March 2012.
  7. ^ MicroMed Technology, Inc. "MicroMed Technology, Inc. Receives European 'CE Mark Certification' To Market The MicroMed DeBakey VAD(R) System". PR Newswire. May 1, 2001.
  8. ^ DeBakey VAD® Child - H030003. FDA.gov. Retrieved 23 June 2016.
  9. ^ a b Asian News International. "World's first new DeBakey heart assist device implanted successfully". Al Bawaba. 18 August 2009.
  10. ^ Berlin Heart. INCOR. May 2013.
  11. ^ Berlin Heart Incor. MyLVAD.com. Retrieved 23 June 2016.
  12. ^ a b Buja, L. Maximilian; Butany, Jagdish. Cardiovascular Pathology. Academic Press, 2015. p. 313.
  13. ^ "Berlin Heart INCOR Implanted Blood Pump with Carmeda Coating Receives CE Mark". Business Wire. May 8, 2003.
  14. ^ HeartMate II Left Ventricular Assist System. HeartMateII.com. Retrieved 23 June 2016.
  15. ^ St. Jude HeartMate II LVAD. MyLVAD.com. Retrieved 23 June 2016.
  16. ^ HeartMate II Left Ventricular Assist System: Clinical Operation and Patient Management. Thoratec Corporation, May 25, 2011. p. 3.
  17. ^ HeartMate II Left Ventricular Assist Device (LVAD) Fact Sheet. Thoratec.com. Retrieved April 8, 2015.
  18. ^ Mechcatie, Elizabeth. "HeartMate II approved as destination therapy". Internal Medicine News. March 1, 2010.
  19. ^ "FDA Approves Left Ventricular Assist System for Severe Heart Failure Patients". Food and Drug Administration. January 20, 2010. Retrieved April 8, 2015.
  20. ^ "FDA approves Heartmate II for patients with severe heart failure". The Medical News. 2010-01-20.
  21. ^ The Jarvik 2000 Ventricular Assist Device. JarvikHeart.com. Retrieved 23 June 2016.
  22. ^ Jarvik 2000 FlowMaker LVAD. MyLVAD.com. Retrieved 23 June 2016.
  23. ^ Jarvik Heart, Inc. "Jarvik 2000 FlowMaker CE Mark Approved in Europe". PR Newswire. May 10, 2005.
  24. ^ Jarvik 2000 Heart as a Bridge to Cardiac Transplantation - Pivotal Trial. ClinicalTrials.gov. Retrieved 23 June 2016.
  25. ^ Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study. ClinicalTrials.gov. Retrieved 23 June 2016.
  26. ^ a b Morshuis, M; Schoenbrodt, M; Nojiri, C; Roefe, D; et al. "DuraHeart magnetically levitated centrifugal left ventricular assist system for advanced heart failure patients". Expert Rev. Med. Devices 7(2), 173–183 (2010).
  27. ^ Evaluation of the Safety and Effectiveness of the DuraHeart LVAS. ClinicalTrials.gov. Retrieved 23 June 2016.
  28. ^ HeartWare, Inc. HeartWare Ventricular Assist System: Instructions for Use. HeartWare.com. November 2012.
  29. ^ HeartWare. HeartWare.com. Retrieved 23 June 2016.
  30. ^ HeartWare, Inc. "HeartWare International Receives CE Mark Addendum, Expanding Label to Include All Patients at Risk of Death From Refractory, End-Stage Heart Failure". IR.HeartWare.com. May 23, 2012.
  31. ^ HeartWare, Inc. "HeartWare Receives FDA Approval for HeartWare® Ventricular Assist System as a Bridge to Heart Transplantation for Patients with Advanced Heart Failure". IR.HeartWare.com. November 20, 2012.
  32. ^ A Clinical Trial to Evaluate the HeartWare Ventricular Assist System (ENDURANCE). U.S. National Institutes of Health. ClinicalTrials.gov. Retrieved June 18, 2016.
  33. ^ HeartAssist5. ReliantHeart.com. Retrieved 23 June 2016.
  34. ^ ReliantHeart. "ReliantHeart HeartAssist5 VAD achieves CE Mark for European distribution" (press release). ReliantHeart.com. November 10, 2013.
  35. ^ Heidelberg University Hospital. "Heidelberg cardiac surgeons implant world's first new DeBakey Heart Assist Device". EurekAlert!. 17 August 2009.
  36. ^ Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation. ClinicalTrials.gov. Retrieved 26 June 2016.
  37. ^ Altman, Lawrence K. "A New Pumping Device Brings Hope for Cheney". New York Times. July 19, 2010.
  38. ^ St. Jude HeartMate 3 LVAD. MyLVAD.com. Retrieved 23 June 2016.
  39. ^ St. Jude Medical, Inc. HeartMate 3 Left Ventricular Assist System (LVAS): Fact Sheet. Thoratec.com. Retrieved 23 June 2016.
  40. ^ St. Jude Medical. "St. Jude Medical Announces CE Mark Approval for the HeartMate 3 Left Ventricular Assist System" (press release). Media.SJM.com. October 12, 2015.
  41. ^ MOMENTUM 3 IDE Clinical Study Protocol (HM3). U.S. National Institutes of Health. ClinicalTrials.gov. Retrieved September 16, 2015.
  42. ^ Thoratec Corporation HeartMate III CE Mark Clinical Investigation Plan (HM III CE Mark). U.S. National Institutes of Health. ClinicalTrials.gov. Retrieved April 8, 2015.
  43. ^ a b Thoratec Corporation. Thoratec Implantable Ventricular Assist Device (IVAD): Instructions for Use. October 2010.
  44. ^ Thoratec PVAD & Thoratec IVAD Fact Sheet Thoratec Corporation. Retrieved April 20, 2015.
  45. ^ No longer listed on the company's product line page as of mid 2015.
  46. ^ Mann, Douglas L.; Felker, G. Michael. Heart Failure: A Companion to Braunwald's Heart Disease. Elsevier Health Sciences, 2014. p. 679.
  47. ^ Thoratec on the Forbes America's Best Small Company's List. Forbes. 2012.
  48. ^ "Australia: Ventracor device banned after three deaths worldwide". The Australian. March 3, 2009.
  49. ^ Boyd, Tony (13 July 2009). "No Heart". Business Spectator.
  50. ^ Carson, Vanda. "Directors flick switch at Ventracor - administrator called in". BusinessDay. March 20, 2009.
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