American Heart Journal
Volume 156, Issue 2 , Pages 201-208, August 2008

Postmarket evaluation of breakthrough technologies

  • Sunil V. Rao, MD

      Affiliations

    • Duke Clinical Research Institute and Duke University Medical Center, Durham, NC
    • Division of Cardiology, Durham Veterans Affairs Medical Center, Durham, NC
    • Corresponding Author InformationReprint requests: Sunil V. Rao, MD, Durham VA Medical Center, 508 Fulton Street (111A) Durham, NC 27705.
    • ,
  • Robert M. Califf, MD

      Affiliations

    • Duke Clinical Research Institute and Duke University Medical Center, Durham, NC
    • Duke Translational Medicine Institute, Durham, NC
    • Duke Center for Education and Research on Therapeutics, Durham, NC
    • ,
  • Judith M. Kramer, MD, MS

      Affiliations

    • Duke Clinical Research Institute and Duke University Medical Center, Durham, NC
    • Duke Center for Education and Research on Therapeutics, Durham, NC
    • ,
  • Eric D. Peterson, MD, MPH

      Affiliations

    • Duke Clinical Research Institute and Duke University Medical Center, Durham, NC
    • Duke Center for Education and Research on Therapeutics, Durham, NC
    • ,
  • Thomas P. Gross, MD, MPH

      Affiliations

    • Center for Devices and Radiological Health, United States Food and Drug Administration, Rockville, MD
    • ,
  • Carl J. Pepine, MD

      Affiliations

    • Division of Cardiovascular Medicine, University of Florida, Gainesville, FL
    • ,
  • David O. Williams, MD

      Affiliations

    • Division of Cardiology, Rhode Island Hospital, Providence, RI
    • ,
  • Dennis Donohoe, MD

      Affiliations

    • Cordis Corporation, Warren, NJ
    • ,
  • Ron Waksman, MD

      Affiliations

    • Division of Cardiology, Washington Hospital Center, Washington, DC
    • ,
  • Roxana Mehran, MD

      Affiliations

    • Cardiovascular Research Foundation, Columbia University Medical Center, New York, NY
    • ,
  • Mitchell W. Krucoff, MD

      Affiliations

    • Duke Clinical Research Institute and Duke University Medical Center, Durham, NC

Received 24 January 2008; accepted 24 January 2008.

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 The opinions or assertions presented herein are the private views of the authors and are not to be construed as conveying either an official endorsement or criticism by the US Department of Health and Human Services, the Public Health Service, or the Food and Drug Administration.

 Funding for this manuscript was provided by the Duke Clinical Research Institute (DCRI). Additional funding for the DCRI/American College of Cardiology “think tank” meeting was provided by the following sponsors: Medtronic, Inc, Abbott Vascular Devices, Cordis Corporation, and Guidant Corporation.

 Sunil V. Rao, MD, has no relationships to disclose. Robert M. Califf, MD is the director of the Duke Translational Medicine Institute and the former director of the Duke Clinical Research Institute, which has relationships with Medtronic, Guidant, Cordis/Johnson & Johnson, and St Jude Medical; all funding is administered through Duke University programs. Judith M. Kramer, MD, has no relationships to disclose. Eric D. Peterson, MD, MPH, has no relationships to disclose. Thomas P. Gross, MD, MPH, has no relationships to disclose. Carl J. Pepine, MD, has no relationships to disclose. David O. Williams, MD, is a consultant for Cordis Corporation, a consultant for Guidant Corporation, and chairs a data safety monitoring board for Abbott Vascular. Dennis Donohoe, MD, is an employee of Cordis Corporation. Ron Waksman, MD, is a consultant for and receives grant support from Medtronic and Boston Scientific Corporation. Roxana Mehran, MD, receives speaker's bureaus from Boston Scientific Corporation, Cordis Corporation, and The Medicines Company, and receives research grants from Boston Scientific Corporation, Cordis Corporation, The Medicines Company, and Conor Medsystems. Mitchell W. Krucoff, MD, has research/scientific consulting relationships with Cordis Corporation/Johnson & Johnson, Boston Scientific Corporation, Medtronic, Abbott (Guidant), Conor Medsystems, Terumo, Biotronik, and St Jude.

PII: S0002-8703(08)00321-9

doi:10.1016/j.ahj.2008.01.036

American Heart Journal
Volume 156, Issue 2 , Pages 201-208, August 2008

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