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OBJECTIVES The purpose of this study was to compare the eligibility of men and women with infrarenal abdominal aortic aneurysms (AAAs) for on-label endovascular aneurysm repair (EVAR) as part of the clinician-Food & Drug Administration (FDA) collaborative effort, the Characterization of Human Aortic Anatomy Project (CHAP). METHODS Computed tomography (CT)(More)
BACKGROUND During summer enteroviral meningitis is a common cause of febrile illness in children, who are typically hospitalized for 2 to 3 days if bacterial infection is suspected. It has been hypothesized that a sensitive polymerase chain reaction (PCR) assay could quickly confirm the diagnosis and subsequently decrease hospitalization costs. However, to(More)
THE feasibility of placing prosthetic grafts within the arterial tree by inserting them via a remote site, guiding them intraluminally to the appropriate location, and fixing them there with attachment systems, such as a variety of expandable stents, has been demonstrated in animals and human subjects (1–3). There is a potential for these transluminally(More)
The preclinical testing of endovascular grafts has evolved significantly since the creation and early testing of these devices; however, there are continued limitations in using preclinical testing to predict clinical performance. Early testing was conducted in the absence of standards and guidance specific to endovascular grafts, and references available(More)
Initial clinical studies of new medical technologies involve a complex balance of research participant benefits versus risks and costs of uncertainty when novel concepts are tested. The Food and Drug Administration Center for Devices and Radiological Health has recently introduced the Early Feasibility Study (EFS) Program for facilitating the conduct of(More)
The conduct of a clinical investigation of a medical device to determine the safety and effectiveness of the device is covered by the investigational device exemptions (IDE) regulation. The purpose of IDE regulation is "to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and(More)
OBJECTIVE United States Food and Drug Administration (FDA)-mandated postapproval studies have long been a mainstay of the continued evaluation of high-risk medical devices after initial marketing approval; however, these studies often present challenges related to patient/physician recruitment and retention. Retrospective single-center studies also do not(More)