title: Postmarket evaluation of breakthrough technologies.
abstract: 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.
authors.affiliation: Duke Clinical Research Institute and Duke University Medical Center, Durham, NC 27705, USA. sunil.rao@duke.edu
authors.forename: Sunil V
authors.initials: SV
authors.lastname: Rao
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
authors.forename: Judith M
authors.initials: JM
authors.lastname: Kramer
authors.forename: Eric D
authors.initials: ED
authors.lastname: Peterson
authors.forename: Thomas P
authors.initials: TP
authors.lastname: Gross
authors.forename: Carl J
authors.initials: CJ
authors.lastname: Pepine
authors.forename: David O
authors.initials: DO
authors.lastname: Williams
authors.forename: Dennis
authors.initials: D
authors.lastname: Donohoe
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: Mitchell W
authors.initials: MW
authors.lastname: Krucoff
mesh_terms: D000818:Animals; D018795:Device Approval / Q000331:legislation & jurisprudence*; D054855:Drug-Eluting Stents / Q000009:adverse effects; D004868:Equipment Failure; D004869:Equipment Safety / Q000592:standards; D033161:Government Regulation; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence; D023421:Models, Animal; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration