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Review times and adverse events for cardiovascular devices

Shorter regulatory review times for high-risk cardiovascular devices correlate with the likelihood of reports of adverse events.

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Figure 1: Schematic of an implanted Sapien transcatheter aortic valve.


  1. Curfman, G. D. & Redberg, R. F. N. Engl. J. Med. 365, 975–977 (2011).

    CAS  Article  Google Scholar 

  2. Kaplan, A. V. & Williams, D. O. Circ. Cardiovasc. Interv. 5, 52–55 (2012).

    Article  Google Scholar 

  3. Kramer, D. B., Xu, S. & Kesselheim, A. S. N. Engl. J. Med. 366, 848–855 (2012).

    CAS  Article  Google Scholar 

  4. Citron, P. Issues Sci. Technol. 27, 23–28 (2011).

    Google Scholar 

  5. Rising, J. P. & Moscovitch, B. PLoS ONE 10, e0117235 (2015).

  6. Kesselheim, A. S. & Hwang, T. J. Act. Ann. Intern. Med. 164, 500–502 (2016).

    Article  Google Scholar 

  7. Olson, M. K. J. Health Econ. 27, 175–200 (2008).

    Article  Google Scholar 

  8. Carpenter, D., Zucker, E. J. & Avorn, J. N. Engl. J. Med. 358, 1354–1361 (2008).

    CAS  Article  Google Scholar 

  9. Wild, C., Erdös, J. & Zechmeister, I. BMC Cardiovasc. Disord. 14, 1–11 (2014).

    Article  Google Scholar 

  10. US Food and Drug Administration Premarket Approval (updated 15 June 2015).

  11. Zuckerman, D. M., Brown, P. & Nissen, S. E. Arch. Intern. Med. 171, 1006–1011 (2011).

    PubMed  Google Scholar 

  12. Hwang, T. J., Sokolov, E., Franklin, J. M. & Kesselheim, A. S. BMJ 353, i3323 (2016).

  13. Fraser, A. G. et al. Eur. Heart J. 32, 1673–1686 (2011).

    Article  Google Scholar 

  14. Eikermann, M. et al. BMJ 346, f2771 (2013).

  15. Department of Health and Human Services, Office of Inspector General Adverse Event Reporting for Medical Devices O EI-01-08-00110 (2009).

  16. Avorn, J. & Kesselheim, A. S. N. Engl. J. Med. 372, 2473–2475 (2015).

    CAS  Article  Google Scholar 

  17. Stern, A. D., Kramer, D. B., Ouellet, M. & Kesselheim, A. S. figshare (2017).

Download references


D.B.K. is supported by a Paul Beeson Career Development Award (NIH-NIA AG045963); A.S.K. is supported by a grant from the Laura and John Arnold Foundation and the Harvard Program in Therapeutic Science.

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Correspondence to Ariel Dora Stern or Aaron S. Kesselheim.

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The authors declare no competing financial interests.

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Stern, A., Kramer, D., Ouellet, M. et al. Review times and adverse events for cardiovascular devices. Nat Biomed Eng 1, 0013 (2017).

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