Postmarket evaluation of breakthrough technologies
Cardiovascular procedures performed in the United States have more than tripled in the last decade, a trend that is expected to continue with the aging of the population, coupled with epidemics of obesity and diabetes mellitus. Helping to drive this increase are new medical devices that address conditions previously treated by medication alone. Many of these novel devices receive expedited reviews before Food and Drug Administration (FDA) approval and are rapidly adopted into clinical practice. However, recent high-profile cases involving potentially dangerous defects in widely used medical devices have increased concerns about the adequacy of premarket trials and postmarket surveillance in establishing the safety of these devices. In response to these concerns, the American College of Cardiology and the Duke Clinical Research Institute sponsored a “think tank” of experts representing the industry, regulatory authorities, academic medicine, and professional societies to examine these concerns and propose possible solutions. This group examined case studies including drug-eluting stents and implantable cardioverter-defibrillators. Challenges inherent in the current system, including the difficulty of establishing accurate event rates for medical devices and potential disincentives for the industry to conduct comprehensive monitoring, were discussed. Possible solutions to these problems included improving and enforcing current regulations, considering creative study design strategies that link pre- and postmarket data, declaring postmarket surveillance a public health issue, creating financial incentives for participation in postmarketing studies, using more relevant animal models, encouraging postmortem device retrieval, and aligning professional societies with the FDA to evaluate breakthrough technologies and communicate findings to patients and clinicians.
To access this article, please choose from the options below
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
© 2008 Mosby, Inc. All rights reserved.
