Results of Expert MeetingsPostmarket evaluation of breakthrough technologies
Section snippets
American College of Cardiology/Duke Clinical Research Institute postmarketing workshop
Given this background, a “think tank” of experts representing the industry, regulatory authorities, academic medicine, and professional societies was convened at the American College of Cardiology (ACC) Heart House in Bethesda, MD, in February of 2004 to discuss key issues and potential solutions for problems related to postmarket evaluation of breakthrough technology. This workshop, entitled “Postmarket evaluation of breakthrough technology: a summit on issues and approaches,” was jointly
Drug-eluting stents case study
As governor of the MDR and MedWatch systems, the FDA is challenged with interpretation of postmarket information, including more than 180,000 adverse event reports annually.17 Determining whether reports involving a breakthrough device represent a true safety signal or simply reflect increased reporting from users with heightened awareness of a novel technology is often difficult. A review of early postrelease experiences with DES crystallizes many key issues.
In April 2003, the FDA issued
Potential advances in postmarket surveillance
Premarket evaluation of breakthrough technologies defined by novelty and high clinical impact is characterized by demonstration of clinical superiority relative to established standard of care in randomized trials, with often dramatic treatment effects. The workshop discussion, thus, primarily focused on approaches to better capture safety data in the premarket arena, track product use patterns after approval, and accurately assess safety concerns as they arise.
Summary
As the pace of development in medical technology accelerates, breakthrough technologies will continue to pose unanticipated safety issues for patients and clinicians. Although there are specific pre- and postmarket approval processes establishing reasonable assurance of safety for devices, the existing system clearly has limitations. The FDA has tools at its disposal to deal with potential safety issues, but recent high-profile problems with devices help clarify areas where these tools might be
References (36)
- et al.
Demographics and cardiology, 1950-2050
J Am Coll Cardiol
(2000) - et al.
Trends in implantable cardioverter-defibrillator racial disparity: the importance of geography
J Am Coll Cardiol
(2005) - et al.
Part I: Identifying holes in the safety net
Am Heart J
(2004) - et al.
Part II: Sealing holes in the safety net
Am Heart J
(2004) - et al.
On- versus off-label use of drug-eluting coronary stents in clinical practice (report from the American College of Cardiology National Cardiovascular Data Registry [NCDR])
Am J Cardiol
(2006) - et al.
Surrogates, substudies, and real clinical end points in trials of drug-eluting stents
J Am Coll Cardiol
(2005) AHA statistical update. Heart disease and stroke statistics: 2006 update
Guidance for industry and FDA staff: expedited review of premarket submissions for devices
- et al.
Cost-effectiveness of sirolimus-eluting stents for treatment of complex coronary stenoses: results from the Sirolimus-Eluting Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SIRIUS) trial
Circulation
(2004) - et al.
Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents
JAMA
(2005)
Life-threatening malfunction of implantable cardiac devices
N Engl J Med
Introducing MEDWatch: a new approach to reporting medications and device adverse effects and product problems
JAMA
Designing a medical device surveillance network: report to congress.
Food and Drugs, Food and Drug Administration, Department of Health and Human Services, Medical Devices, Pre-market approval of medical devices (Title 21, Vol. 8)
Ensuring the safety of marketed medical devices: CDRH's Medical Device Postmarket Safety Program
Center for Devices and Radiological Health Condition of Approval Studies as a Postmarket tool for PMA approved cohorts 1998-2000
Committee on Postmarket Surveillance of Pediatric Medical Devices.
Medical device development: from prototype to regulatory approval
Circulation
Cited by (28)
Introduction to vaccine development
2021, Practical Aspects of Vaccine DevelopmentTechniques to Optimize the Use of Optical Coherence Tomography: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database
2019, Cardiovascular Revascularization MedicineCitation Excerpt :Recognition of optimal acquisition techniques can mitigate future events. Sufficient post-market data for interventional devices has been a concern for some time and is an important factor to help prevent future events [21]. The MAUDE database aids post-market surveillance; however, it is significantly limited by the voluntary and inconsistent nature of data input.
Recommendations for primary studies evaluating therapeutic medical devices were identified and systematically reported through reviewing existing guidance
2018, Journal of Clinical EpidemiologyCitation Excerpt :Multi-center trials can help to overcome sample size limitations (r1, r5) [8,11,20,33]. To assure the applicability of findings to clinical practice, studies should investigate the TMD in the same patients, the same clinical context, and with the indication as in practice (r13, r11) [9,44]. Broad patient eligibility criteria should be used to overcome variations in trials and to reach recruitment targets (r12) [20].
The Atlantic divide in coronary heart disease: Epidemiology and patient care in the US and Portugal
2017, Revista Portuguesa de CardiologiaCardiovascular drug development: Is it dead or just hibernating?
2015, Journal of the American College of Cardiology
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.