Embedded Files
Recent enthusiasm to extend the application of aortic endografts has led to the development of new techniques that require modification of approved endografts to accommodate anatomic variations. For the purposes of this report, a modified aortic endograft is defined as a physical modification of an existing approved device (including the implant or deployment system) in such a way that its potential risks and benefits cannot be extrapolated from the United States Food and Drug Administration (FDA)-approved studies upon which the approval of the original unmodified commercial device was based. Examples of such modification include surgeon-constructed fenestrations and side branches. All aortic endografts are defined by federal law as significant-risk devices, and regulations for their use are enforced by the FDA. Accordingly, clinical studies using modified aortic endografts must comply with these regulations to ensure patient safety and accurate reporting of clinical outcomes. Currently, there are two mechanisms to conduct FDA-approved clinical studies of significant risk devices: manufacturer-sponsored or investigator-sponsored Investigational Device Exemptions (IDEs). To get FDA approval to market an endovascular graft, manufacturers must submit a Premarket Approval (PMA) application that provides a reasonable assurance of safety and effectiveness using valid scientific evidence. PMA approval usually includes requirements for training programs and postmarket follow-up programs to provide surveillance after introduction. Investigator-sponsored IDEs enable investigational device evaluation using the same criteria for scientific justification and study conduct but are generally not intended to support a device marketing application or to address training. As outlined in the Federal Food, Drug, and Cosmetic Act and interpreted in the Federal Register and the Code of Federal Regulations that codifies the rules published in the Federal Register, the medical device law and regulations apply equally to manufacturers and investigators conducting studies. These laws and regulations must be considered when new devices or modification of devices are studied. If significant-risk devices or modifications of significant-risk devices are used in clinical studies, Institutional Review Board (IRB) and IDE approval are required. For modified aortic endografts, IRB approval alone is not adequate because the FDA has determined that all aortic endovascular graft studies are significant-risk studies. This requirement has implications on the investigator and institutional responsibilities, the patient consent, conduct of the study, collection of data, reimbursement for procedures, and reporting to the IRB and the FDA. Scientific presentations and publications must clearly delineate the nature of the study, method of approval, and mechanism to assess outcomes of interventions. To date, the Center for
Report abuse