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The FDA Perspective on Heart Failure Devices

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Device Therapy in Heart Failure

Part of the book series: Contemporary Cardiology ((CONCARD))

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Abstract

The Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) is charged with ensuring that manufacturers of new medical devices demonstrate a reasonable assurance that their devices are safe and effective prior to approval for commercial distribution in the United States. CDRH also monitors the performance of medical devices once approved for distribution and introduced into commerce to evaluate the ongoing risk–benefit profile in the interest of protecting the public health. This chapter reviews regulatory terminology, submission types, clinical trial design, product labeling, recalls, and other issues related to the regulation of heart failure devices.

This chapter represents the professional opinions of the authors and is not an official document, agency guidance, or policy of the US Government, the Department of Health and Human Services, or the Food and Drug Administration, nor should any official endorsement be inferred.

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References

  1. The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry. Available at: http:// www.fda.gov/ cdrh/ode/guidance/1332.pdf. Accessed November 29, 2007.

  2. US Food and Drug Administration – Center for Devices and Radiological Health. Available at: http://www.fda.gov/cdrh/. Accessed November 29, 2007.

  3. Design Control Guidance for Medical Device Manufacturers. Available at: http://www.fda.gov/ cdrh/comp/designgd.pdf. Accessed November 29, 2007.

  4. Office of Orphan Products Development. Available at: http://www.fda.gov/orphan/. Accessed November 29, 2007.

  5. Humanitarian Use Devices. Available at: http://www.fda.gov/cdrh/ode/hdeinfo.html. Accessed November 29, 2007.

  6. Guidance on IDE Policies and Procedures. Available at: http://www.fda.gov/cdrh/ode/idepolcy.pdf. Accessed November 29, 2007.

  7. Medical Device Recalls. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/medicaldevicesafety/recalls.cfm. Accessed November 29, 2007.

  8. Device Advice. Available at: http://www.fda.gov/cdrh/devadvice. Accessed November 29, 2007.

  9. Aaronson KD, Schwartz JS, Chen TM, Wong KL, Goin JE, Mancini DM. Development and prospective validation of a clinical index to predict survival in ambulatory patients referred for cardiac transplant evaluation. Circulation 1997 Jun; 95(12): 2597–9.

    Google Scholar 

  10. Levy WC, Mazaffarian D, Linker DT, Sutradhar SC, Anker SD, Cropp AB, et al. The Seattle Heart Failure Model: Prediction of survival in heart failure. Circulation 2006 Mar; 113(11): 1424–33.

    Article  PubMed  Google Scholar 

  11. Frankel DS, Piette JD, Jessup M, Craig K, Pickering F, Goldberg LR. Validation of prognostic models among patients with advanced heart failure. J Card Fail 2006 Aug; 12(6): 430–8.

    Article  PubMed  Google Scholar 

  12. Farrar DJ, Hill JD, Pennington DG, McBride LR, Holman WL, Kormos RL, et al. Preoperative and postoperative comparison of patients with univentricular and biventricular support with the Thoratec ventricular assist device as a bridge to cardiac transplantation. J Thorac Cardiovasc Surg 1997 Jan; 113(1): 202–9.

    Article  CAS  PubMed  Google Scholar 

  13. El-Banayosy A, Arusoglu L, Kizner L, Tenderich G, Minami K, Inoue K, et al. Novacor left ventricular assist system versus Heartmate vented electric left ventricular assist system as a long-term mechanical circulatory support device in bridging patients: a prospective study. J Thorac Cardiovasc Surg 2000 Mar; 119(3): 581–7.

    Article  CAS  PubMed  Google Scholar 

  14. Minami K, El-Banayosy A, Sezai A, Arusoglu L, Sarnowsky P, Fey O, et al. Morbidity and outcome after mechanical ventricular support using Thoratec, Novacor, and HeartMate for bridging to heart transplantation. Artif Organs 2000 Jun; 24(6): 421–6.

    Article  CAS  PubMed  Google Scholar 

  15. Di Bella I, Pagani F, Banfi C, Ardemagni E, Capo A, Klersy C, et al. Results with the Novacor assist system and evaluation of long-term assistance. Eur J Cardiothorac Surg 2000 Jul; 18(1): 112–6.

    Article  CAS  PubMed  Google Scholar 

  16. El-Banayosy A, Korfer R, Arusoglu L, Kizner L, Morshuis M, Milting H, et al. Device and patient management in a bridge-to-transplant setting. Ann Thorac Surg 2001 Mar; 71(3 Suppl): S98–102.

    Article  CAS  PubMed  Google Scholar 

  17. Frazier OH, Rose EA, Oz MC, Dembitsky W, McCarthy P, Radovancevic B, et al. Multicenter clinical evaluation of the HeartMate vented electric left ventricular assist system in patients awaiting heart transplantation. J Thorac Cardiovasc Surg 2001 Dec; 122(6): 1186–95.

    Article  CAS  PubMed  Google Scholar 

  18. Mancini DM, Eisen H, Kussmaul W, Mull R, Edmunds LH, Wilson JR. Value of peak exercise oxygen consumption for optimal timing of cardiac transplantation in ambulatory patients with heart failure. Circulation 1991 Mar; 83(3): 778–86.

    CAS  PubMed  Google Scholar 

  19. Stelken AM, Younis LT, Jennison SH, Miller DD, Miller LW, Shaw LJ, et al. Prognostic value of cardiopulmonary exercise testing using percent achieved of predicted peak oxygen uptake for patients with ischemic and dilated cardiomyopathy. J Am Coll Cardiol 1996 Feb; 27(2): 345–52.

    Article  CAS  PubMed  Google Scholar 

  20. Lund LH, Aaronson KD, Mancini DM. Validation of peak exercise oxygen consumption and the Heart Failure Survival Score for serial risk stratification in advanced heart failure. Am J Cardiol 2005 Mar; 95(6): 734–41.

    Article  PubMed  Google Scholar 

  21. Pina IL, Karalis DG. Comparison of four exercise protocols using anaerobic threshold measurement of functional capacity in congestive heart failure. Am J Cardiol 1990 May; 65(18): 1269–71.

    Article  CAS  PubMed  Google Scholar 

  22. Chua TP, Ponikowski P, Harrington D, Anker SD, Webb-Peploe K, Clark AL, et al. Clinical correlates and prognostic significance of the ventilatory response to exercise in chronic heart failure. J Am Coll Cardiol 1997 Jun; 29(7): 1585–90.

    Article  CAS  PubMed  Google Scholar 

  23. Whellan DJ, O’Connor CM, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, et al. Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale. Am Heart J 2007 Feb; 153(2): 201–11.

    Article  PubMed  Google Scholar 

  24. Lipkin DP, Scriven AJ, Crake T, Poole-Wilson PA. Six minute walking test for assessing exercise capacity in chronic heart failure. Br Med J (Clin Res Ed) 1986 Mar; 292(6521): 653–55.

    Article  CAS  Google Scholar 

  25. Lipkin DP, Canepa-Anson R, Stephens MR, Poole-Wilson PA. Factors determining symptoms in heart failure: comparison of fast and slow exercise tests. Br Heart J 1986 May; 55(5): 439–45.

    Article  CAS  PubMed  Google Scholar 

  26. Bittner V, Weiner DH, Yusuf S, Rogers WJ, McIntyer KM, Bangdiwala, SI, et al. Prediction of mortality and morbidity with a 6-minute walk test in patients with left ventricular dysfunction. SOLVD Investigators. JAMA 1993; 270(14): 1702–07.

    Article  CAS  PubMed  Google Scholar 

  27. ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS Statement: Guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002 Jul; 166(1): 111–7.

    Google Scholar 

  28. Normand SL, Rector TS, Neaton JD, Pina IL, Lazar RM, Proestel SE, et al. Clinical and analytical considerations in the study of health status in device trials for heart failure. J Card Fail 2005 Jun; 11(5): 396–403.

    Article  PubMed  Google Scholar 

  29. Guyatt GH, Kirshner B, Jaeschke R. Measuring health status: what are the necessary measurement properties? J Clin Epidemiol 1992 Dec; 45(12): 1341–5.

    Article  CAS  PubMed  Google Scholar 

  30. Rector TS, Cohn JN. Assessment of patient outcome with the Minnesota Living with Heart Failure questionnaire: reliability and validity during a randomized, double-blind, placebo-controlled trial of pimobendan. Pimobendan Multicenter Research Group. Am Heart J 1992 Oct; 124: 1017–25.

    Article  CAS  PubMed  Google Scholar 

  31. Rector TS, Kubo SH, Cohn JN. Validity of the Minnesota Living with Heart Failure questionnaire as a measure of therapeutic response to enalapril or placebo. Am J Cardiol 1993 May;71: 1106–10.

    Article  CAS  PubMed  Google Scholar 

  32. Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol 2000 Apr; 35: 1245–55.

    Article  CAS  PubMed  Google Scholar 

  33. Brooks, RG, Jendteg S, Lindgren B, Persson U, Bjork S. EuroQol: health-related quality of life measurement. Results of the Swedish questionnaire exercise. Health Policy 1991; 18(1): 37–48.

    Article  CAS  PubMed  Google Scholar 

  34. Brooks RG. EuroQol: the current state of play. Health Policy 1996; 37(1): 53–72.

    Article  CAS  PubMed  Google Scholar 

  35. Mosca L, Merz NB, Blumenthal RS, Cziraky MJ, Fabunmi RP, Sarawate C, et al. Opportunity for intervention to achieve American Heart Association guidelines for optimal lipid levels in high-risk women in a managed care setting. Circulation 2005 Feb; 111(4): 488–93.

    Article  PubMed  Google Scholar 

  36. Rosamond W, Flegal K, Friday G, Furie K, Go A, Greenlund K, et al. Heart disease and stroke statistics—2007 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 2007 Feb; 115(5): e69–171.

    Google Scholar 

  37. Faris O, Chen E, Berman M, Moynahan M, Zuckerman B. A US Food and Drug Administration perspective on cardiac resynchronization and ventricular assist device trials. Congest Heart Fail 2005 Jul–Aug; 11(4): 207–11.

    Google Scholar 

  38. Summary of safety and effectiveness. Medtronic InSync. Available at: http://www.fda.gov/cdrh/pdf/P010015b.pdf. Accessed November 29, 2007.

  39. Summary of safety and effectiveness. Medtronic InSync ICD. Available at: http://www.fda.gov/cdrh/pdf/P010031b.pdf. Accessed November 29, 2007.

  40. Summary of safety and effectiveness. Guidant CONTAK CD. Available at: http://www.fda.gov/cdrh/pdf/P010012b.pdf. Accessed November 29, 2007.

  41. Summary of safety and effectiveness. St. Jude Epic and Atlas CRT-D. Available at: http://www.fda.gov/cdrh/pdf/P010012b.pdf. Accessed November 29, 2007.

  42. Summary of safety and effectiveness. Biotronik Tupos and Kronos CRT-D. Available at: http://www.fda.gov/cdrh/pdf5/p050023b.pdf. Accessed November 29, 2007.

  43. Summary of safety and effectiveness. Guidant COMPANION Trial. Available at: http://www.fda.gov/cdrh/pdf/P010012S026b.pdf. Accessed November 29, 2007.

  44. Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure. Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. N Engl J Med 2005 Apr; 352(15): 1539–49.

    Article  CAS  PubMed  Google Scholar 

  45. Premarket Approval (PMA) Database. Thoratec Ventricular Assist Device (VAD) System. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/PMA.cfm?ID=13935. Accessed November 29, 2007.

  46. Summary of safety and effectiveness. Thoratec HeartMate VE VAD. Available at: http://www.fda.gov/cdrh/pdf/p920014s007b.pdf. Accessed November 29, 2007.

  47. Summary of safety and effectiveness. WorldHeart Novacor Left Ventricular Assist System. Available at http://www.fda.gov/cdrh/pdf/P980012b.pdf. Accessed November 29, 2007.

  48. Premarket Approval (PMA) Database. Thoratec HeartMate Left Ventricular Assist System (SNAP-VE LVAS). Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/PMA.cfm?ID=13924. Accessed November 29, 2007.

  49. Summary of safety and effectiveness. Syncardia temporary Total Artificial Heart (TAH-T). Available at http://www.fda.gov/cdrh/PDF3/p030011b.pdf. Accessed November 29, 2007.

  50. Summary of safety and probable benefit. Abiomed Abiocar Replacement Heart. Available at http://www.fda.gov/cdrh/pdf4/H040006b.pdf. Accessed November 29, 2007.

  51. Rose EA, Gelijns AC, Moskowitz AJ, Heitjan DF, Stevenson LW, Dembitsky W, et al. Long-term mechanical left ventricular assistance for end-stage heart failure. Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group. N Engl J Med 2001 Nov; 345(20): 1435–43.

    Article  CAS  PubMed  Google Scholar 

  52. CDRH Advisory Committees. Available at: http://www.fda.gov/cdrh/panel/. Accessed November 29, 2007.

  53. Thoratec REMATCH and Medtronic InSync ICD Advisory Meetings. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=281. Accessed November 29, 2007.

  54. Guidant COMPANION Advisory Meeting. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=514. Accessed November 29, 2007.

  55. Acorn CorCap Cardiac Support Device and Abiomed Abiocor Total Artificial Heart Advisory Meetings. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=596. Accessed November 29, 2007.

  56. Medtronic Chronicle Implantable Hemodynamic Monitoring System Advisory Meeting. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=677. Accessed November 29, 2007.

  57. Stent Thrombosis in Coronary Drug-Eluting Stents Advisory Meeting. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=672. Accessed November 29, 2007.

  58. ODE Site Visit Program. Available at: http://www.fda.gov/cdrh/ode/ode-sitevisit.html. Accessed November 29, 2007.

  59. Interagency Registry for Mechanically Assisted Circulatory Support. Available at: http://www.intermacs.org/. Accessed November 29, 2007.

  60. Baldwin JT, Borovetz HS, Duncan BW, Gartner MJ, Jarvik RK, Weiss WJ, et al. The national heart, lung, and blood institute pediatric circulatory support program. Circulation 2006 Jan; 113: 147–55.

    Article  PubMed  Google Scholar 

  61. FDA Workshop on Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices), January 20, 2006. Available at: http://www.fda.gov/cdrh/meetings/012006workshop/index.html. Accessed November 29, 2007.

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Authors and Affiliations

  1. Division of Cardiovascular Devices, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Rockville, MD, USA

    Matthew G. Hillebrenner MSE

  2. U.S. Food and Drug Administration, Rockville, MD, USA

    Eric A. Chen MSE, Owen P. Faris PhD & Kathryn M. O’Callaghan

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  1. Matthew G. Hillebrenner MSE
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  2. Eric A. Chen MSE
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  3. Owen P. Faris PhD
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  4. Kathryn M. O’Callaghan
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Editors and Affiliations

  1. Beth Israel Deaconess Medical Center, Harvard Medical School, Pilgrim Road 185, Boston, 02215, U.S.A.

    William H. Maisel

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Hillebrenner, M.G., Chen, E.A., Faris, O.P., O’Callaghan, K.M. (2010). The FDA Perspective on Heart Failure Devices. In: Maisel, W. (eds) Device Therapy in Heart Failure. Contemporary Cardiology. Humana Press. https://doi.org/10.1007/978-1-59745-424-7_4

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  • DOI: https://doi.org/10.1007/978-1-59745-424-7_4

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