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Approval of High-Risk Medical Devices in the US: Implications for Clinical Cardiology

  • Public Health Policy (NK Choudhry, Section Editor)
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Abstract

Since 1976, the US Food and Drug Administration (FDA) has used the premarket approval (PMA) process to approve high-risk medical devices, including implantable cardioverter defibrillators (ICDs), coronary stents, and artificial heart valves. The PMA process is widely viewed as a rigorous evaluation of device safety and effectiveness, though recent recalls—most notably related to underperforming ICD leads—have raised concerns about whether physicians and patients should sometimes be more wary about devices approved via this pathway. The FDA must utilize a “least burdensome” approach to approve new medical devices, and many widely used device models have been approved as supplements to existing PMA-approved devices with limited clinical testing. A recent Supreme Court ruling has made it difficult for patients harmed by unsafe PMA-approved devices to seek damages in court. Cardiologists who utilize high-risk medical devices should be aware that FDA approval of new devices relies on variable levels of evidence and does not necessarily indicate improved effectiveness over existing models. Clinician and patient engagement in postmarket surveillance and comparative effectiveness research remains imperative.

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References

Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

  1. Kurtz SM, Ochoa JA, Lau E, Shkolnikov Y, Pavri BB, Frisch D, et al. Implantation trends and patient profiles for pacemakers and implantable cardioverter defibrillators in the United States: 1993-2006. Pacing Clin Electrophysiol. 2010;33:705–11. Available from: http://www.ncbi.nlm.nih.gov/pubmed/20059714.

    Article  PubMed  Google Scholar 

  2. Greenspon AJ, Patel JD, Lau E, Ochoa J. a, Frisch DR, Ho RT, et al. Trends in permanent pacemaker implantation in the United States from 1993 to 2009: increasing complexity of patients and procedures. J Am Coll Cardiol. 2012;60:1540–5. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22999727.

    Article  PubMed  Google Scholar 

  3. Supreme Court of the United States. Medtronic, Inc. v. Lohr. 1996.

  4. Supreme Court of the United States. Riegel v. Medtronic, Inc. 2008.

  5. Kramer DB, Xu S, Kesselheim AS. Regulation of medical devices in the United States and European Union. N Engl J Med. 2012;366:848–55. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22332952.

    Article  CAS  PubMed  Google Scholar 

  6. Dhruva SS, Bero LA, Redberg RF. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA. 2009;302:2679–85. Available from: http://www.ncbi.nlm.nih.gov/pubmed/20040556.

    Article  CAS  PubMed  Google Scholar 

  7. Chen CE, Dhruva SS, Redberg RF. Inclusion of comparative effectiveness data in high-risk cardiovascular device studies at the time of premarket approval. JAMA. 2012;308:1740–2. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23117769.

    Article  CAS  PubMed  Google Scholar 

  8. Kramer DB, Mallis E, Zuckerman BD, Zimmerman BA, Maisel WH. Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007. Am J Ther. 2010;17:2–7. Available from: http://www.ncbi.nlm.nih.gov/pubmed/20038828.

    Article  PubMed  Google Scholar 

  9. Rome BN, Kramer DB, Kesselheim AS. FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012. JAMA. 2014;311:385–91. doi:10.1001/jama.2013.284986. The authors studied cardiac implantable electronic devices approved from 1979-2012, finding that 77 original PMAs were the subject of 5,289 supplement PMAs. They found that nearly all devices used today were approved as PMA supplements to older models.

  10. Hauser RG, Abdelhadi R, McGriff D, Retel LK. Deaths caused by the failure of Riata and Riata ST implantable cardioverter-defibrillator leads. Heart Rhythm. Elsevier Inc.; 2012;9:1227–35. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22449741. The authors searched the FDA event database and found that failure of the recalled Riata ICD lead caused 22 deaths. Riata was approved via a PMA supplement application without any clinical data, and this study highlights the importance of ensuring adequate premarket testing to prevent unsafe devices from being used in patient care.

  11. Hauser RG, Almquist AK. Learning from our mistakes? Testing new ICD technology. N Engl J Med. 2008;359:2517–9. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19073974.

    Article  CAS  PubMed  Google Scholar 

  12. Maisel WH. Semper fidelis–consumer protection for patients with implanted medical devices. N Engl J Med. 2008;358:985–7. Available from: http://www.ncbi.nlm.nih.gov/pubmed/18322280.

    Article  CAS  PubMed  Google Scholar 

  13. Zuckerman DM, Brown P, Nissen SE. Medical device recalls and the FDA approval process. Arch Intern Med. 2011;171:1006–11. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21321283.

    PubMed  Google Scholar 

  14. US Food and Drug Adminstration. List of Device Recalls. 2014. Available from: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/default.htm

  15. Medical Device Amendments of 1976. US: Public Law 94-295; 1976. Available from: http://www.gpo.gov/fdsys/pkg/STATUTE-90/pdf/STATUTE-90-Pg539.pdf

  16. Institute of Medicine. Medical devices and the public’s health: The 510(k) clearance process at 35 Years. Washington, DC: The National Acadamies Press; 2011. Available from: http://www.iom.edu/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years.aspx.

    Google Scholar 

  17. Curfman GD, Morrissey S, Drazen JM. A pivotal medical-device case. N Engl J Med. 2008;358:76–7. Available from: http://www.ncbi.nlm.nih.gov/pubmed/18172178.

    Article  CAS  PubMed  Google Scholar 

  18. US Food and Drug Adminstration. Premarket Notification (510k) . 2010. Available from: http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/default.htm

  19. Ardaugh BM, Graves SE, Redberg RF. The 510(k) ancestry of a metal-on-metal hip implant. N Engl J Med. 2013;368:97–100. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23301729.

    Article  CAS  PubMed  Google Scholar 

  20. US Food and Drug Adminstration. Premarket Approval (PMA). 2012. Available from: http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/

  21. US Food and Drug Adminstration. 515 Program Initiative. 2013. Available from: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm240310.htm

  22. Safe Medical Devices Act of 1990. US: Public Law 101-629; 1990. Available from: http://www.gpo.gov/fdsys/pkg/STATUTE-104/pdf/STATUTE-104-Pg4511.pdf

  23. Food and Drug Administration Modernization Act of 1997. 2296 US: 111; 1997.

  24. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, Center for Biologics Evaluation and Research. The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry. 2002.

  25. Premarket Approval of Medical Devices. 21 CFR 814. 1986.

  26. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research. Guidance for Industry and FDA Staff: Modifications to Devices Subject to Premarket Approval ( PMA ) - The PMA Supplement Decision-Making Process. 2008. Available from: http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm089274.htm

  27. US Food and Drug Adminstration. Guidance for Industry and FDA Staff Real-Time Premarket Approval Application (PMA) Supplements. 2006. Available from: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089602.htm

  28. Medical Device User Fee and Modernization Act of 2002. US: Public Law 107-250; 2002. Available from: http://www.gpo.gov/fdsys/pkg/PLAW-107publ250/content-detail.html

  29. Kramer DB, Kesselheim AS. User fees and beyond–the FDA Safety and Innovation Act of 2012. N Engl J Med. 2012;367:1277–9. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23034017.

    Article  CAS  PubMed  Google Scholar 

  30. US Food and Drug Adminstration. PMA Review Fees. 2013. Available from: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm048161.htm

  31. Shein MJ, Schultz DG. Testing new ICD technology. N. Engl. J. Med. [Internet]. 2008 [cited 2013 Aug 29];359:2610. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19073982

  32. US Food and Drug Adminstration. Medical Devices 522 Postmarket Surveillance Studies – Frequently Asked Questions (FAQs). 2013. Available from: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/PostmarketSurveillance/ucm134497.htm

  33. Blake K. Postmarket surveillance of medical devices: current capabilities and future opportunities. J. Interv. Card. Electrophysiol. 2013;36:119–27. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23479089. This review article discusses the current systems for postmarket device surveillance and proposes ways to improve postmarket surveillance to better assure patient safety.

  34. Hauser RG, Mugglin AS, Friedman PA, Kramer DB, Kallinen L, McGriff D, et al. Early detection of an underperforming implantable cardiovascular device using an automated safety surveillance tool. Circ Cardiovasc Qual Outcomes. 2012;5:189–96. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22396584.

    Article  PubMed  Google Scholar 

  35. Normand S-LT, Hatfield L, Drozda J, Resnic FS. Postmarket surveillance for medical devices: America’s new strategy. BMJ. 2012;345:e6848. Available from: http://www.bmj.com.ezp-prod1.hul.harvard.edu/content/345/bmj.e6848.pdf+html.

    Article  PubMed  Google Scholar 

  36. Department US. of Health and Human Services Food and Drug Administration. Unique Device Identification System. Fed Regist. 2013;78:58786–828. Available from: https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-system.

    Google Scholar 

  37. US Food and Drug Adminstration. Premarket Approval (PMA) Database. 2012. Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm.

  38. US Food and Drug Adminstration. FDA Transparency Initiative. 2012. Available from: http://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/default.htm.

  39. US Food and Drug Adminstration. Premarket Approval (PMA) Clinical Trials Database. 2011. Available from: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm204243.htm.

  40. United States Court of Appeals for the Eighth Circuit. In re: Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation. 2010.

  41. Supreme Court of the United States. Wyeth v. Levine. 2009.

  42. Patsner B. Riegel v. Medtronic, Inc.: revisiting pre-emption for medical devices. J Law Med Ethics. 2009;37:305–17. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19493075.

    Article  PubMed  Google Scholar 

  43. Wartman GJ. Life after Riegel: a fresh look at medical device preemption one year after Riegel v. Medtronic, Inc. Food Drug Law J. 2009;64:291–311. Available from: http://www.ncbi.nlm.nih.gov/publimed/19999286.

    PubMed  Google Scholar 

  44. Feder BJ. Medical Device Ruling Redraws Lines on Lawsuits. New York Times. 2008. Available from: http://www.nytimes.com/2008/02/22/business/22device.html?pagewanted=all

  45. United States District Court of Arizona. Ramirez v. Medtronic, Inc. 2013.

  46. United States Court of Appeals for the Ninth Circuit. Stengel v. Medtronic, Inc. 2013.

  47. Curfman GD, Morrissey S, Drazen JM. The Medical Device Safety Act of 2009. N Engl J Med. 2009;360:1550–1. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19297562.

    Article  CAS  PubMed  Google Scholar 

  48. Redberg RF, Dhruva SS. Medical device recalls: get it right the first time: Comment on “Medical device recalls and the FDA approval process”. Arch Intern Med. 2011;171:1011–2. Available from: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3191575&tool=pmcentrez&rendertype=abstract.

    PubMed  Google Scholar 

  49. Lampert R, Wang Y, Curtis JP. Variation among hospitals in selection of higher-cost, “higher-tech,” implantable cardioverter-defibrillators: data from the National Cardiovascular Data Registry (NCDR) Implantable Cardioverter/Defibrillator (ICD) Registry. Am. Heart J. Mosby, Inc.; 2013;165:1015–1023.e2. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23708175.

  50. Kesselheim AS, Avorn J. The role of litigation in defining drug risks. JAMA. 2007;297:308–11. Available from: http://www.ncbi.nlm.nih.gov/pubmed/17227983.

    Article  CAS  PubMed  Google Scholar 

  51. Goodman SN, Redberg RF. Opening the FDA Black Box. JAMA. 2014;311:361–3. Available from: http://www.ncbi.nlm.nih.gov/pubmed/24449313

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Acknowledgments

Benjamin N. Rome has received support from a Harvard Medical School fellowship.

Daniel B. Kramer has received grant support from NIH/NIA (Paul B. Beeson career development award to Dr. Kramer [K23AG045963]).

Aaron S. Kesselheim has received the following in grant support: Supported by a Robert Wood Johnson Foundation Investigator Award in Health Policy Research; Supported by a career development award from the Agency for Healthcare Research and Quality (K08HS18465-01); Supported by a grant as a Greenwall Faculty Scholar in Bioethics from the Greenwall Foundation; and Received a contract (2011) from the US FDA Center for Devices and Radiological Health to conduct comparative study of device regulation in US and EU.

Compliance with Ethics Guidelines

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Conflict of Interest

Benjamin N. Rome, Daniel B. Kramer, and Aaron S. Kesselheim declare that they have no conflict of interest.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.

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Authors and Affiliations

  1. Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, 1620 Tremont St., Suite 3030, Boston, MA, 02120, USA

    Benjamin N. Rome, Daniel B. Kramer & Aaron S. Kesselheim

  2. Harvard Medical School, 25 Shattuck St., Boston, MA, 02215, USA

    Benjamin N. Rome, Daniel B. Kramer & Aaron S. Kesselheim

  3. Beth Israel Deaconess Medical Center, 185 Pilgrim Road, West Campus B4, Boston, MA, 02215, USA

    Daniel B. Kramer

  4. Hebrew SeniorLife Institute for Aging Research, Roslindale, MA, USA

    Daniel B. Kramer

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  1. Benjamin N. Rome
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Correspondence to Aaron S. Kesselheim.

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Rome, B.N., Kramer, D.B. & Kesselheim, A.S. Approval of High-Risk Medical Devices in the US: Implications for Clinical Cardiology. Curr Cardiol Rep 16, 489 (2014). https://doi.org/10.1007/s11886-014-0489-0

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