Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Comment
  • Published:

Review times and adverse events for cardiovascular devices

Nature Biomedical Engineering volume 1, Article number: 0013 (2017) Cite this article

Subjects

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

This is a preview of subscription content, access via your institution

Relevant articles

Open Access articles citing this article.

Access options

Buy this article

  • Purchase on Springer Link
  • Instant access to full article PDF
Buy now

Prices may be subject to local taxes which are calculated during checkout

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

References

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

    Article  CAS  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).

    Article  CAS  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).

    Article  CAS  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 Approvalhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm (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).

    Article  CAS  Google Scholar 

  17. Stern, A. D., Kramer, D. B., Ouellet, M. & Kesselheim, A. S. figsharehttps://dx.doi.org/10.6084/m9.figshare.4244264 (2017).

Download references

Acknowledgements

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.

Author information

Authors and Affiliations

  1. Harvard Business School, Soldiers Field Road, Boston, Massachusetts, 02163, USA

    Ariel Dora Stern & Melissa Ouellet

  2. Ariadne Labs at Brigham and Women's Hospital and the Harvard T. H. Chan School of Public Health, Boston, Massachusetts, 02215, USA

    Ariel Dora Stern

  3. Harvard Medical School, 25 Shattuck Street, Boston, Massachusetts, 02115, USA

    Daniel B. Kramer & Aaron S. Kesselheim

  4. Division of Pharmacoepidemiology and Pharmacoeconomics, Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital, 75 Francis Street, Boston, Massachusetts, 02115, USA

    Daniel B. Kramer & Aaron S. Kesselheim

  5. Richard and Susan Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, USA

    Daniel B. Kramer

Authors
  1. Ariel Dora Stern
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Daniel B. Kramer
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Melissa Ouellet
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Aaron S. Kesselheim
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding authors

Correspondence to Ariel Dora Stern or Aaron S. Kesselheim.

Ethics declarations

Competing interests

The authors declare no competing financial interests.

Supplementary information

Supplementary Information

Regulatory review times and adverse-event reports for cardiovascular devices. (PDF 473 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Stern, A., Kramer, D., Ouellet, M. et al. Review times and adverse events for cardiovascular devices. Nat Biomed Eng 1, 0013 (2017). https://doi.org/10.1038/s41551-016-0013

Download citation

  • Published:

  • DOI: https://doi.org/10.1038/s41551-016-0013

This article is cited by

Search

Advanced search

Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing