Ongoing FDA evaluation of approved endovascular grafts.

There have been numerous device integrity and clinical problems identified with endovascular grafts for aortic aneurysm repair, some during clinical investigations and others after marketing approval. When significant failures are identified during clinical studies, enrollment of patients is suspended. This limits the exposure of patients to the technology while failure analyses are conducted. Patient safety is further protected by increased follow-up surveillance for patients with identified device failures. After approval for marketing, the Food and Drug Administration (FDA) is less likely to stop the use of a device when new problems are identified, unless the new problem drastically alters the safety and effectiveness profile of the device. Rather, providing current, accurate information regarding commercially available devices is the primary method used by the FDA to protect the public health in these circumstances. There are now three endovascular grafts approved for marketing in the United States, all for the treatment of abdominal aortic aneurysms. To obtain marketing approval, a manufacturer must submit data from clinical studies conducted to demonstrate the safety and effectiveness of the device. These data undergo extensive review by FDA medical officers and statisticians prior to presentation of the information to the FDA advisory panel. In addition, the manufacturer and selected investigational sites are audited by the FDA Division of Bioresearch Monitoring to determine adherence to device regulations and the clinical protocol. Inspectors also compare patient data to the database for the study to evaluate the accuracy of the translation. The extensive clinical data reviewed by the FDA are summarized in the approved device label. These data are intended to help clinicians with patient selection and should provide an indication as to the anticipated performance of the device. The Office of Device Evaluation has implemented the following mechanism to provide current performance data to clinicians after the marketing of endovascular grafts. After approval, manufacturers of such devices are required to conduct postmarket studies that involve continued follow-up of patients enrolled in the clinical investigation. As data have been generated and reported from these studies, it has become clear that the information in the original labeling which reflects the clinical trial experience is not adequate to describe the device performance after marketing. Accordingly, the FDA now requires that updated clinical information be communicated to users of the devices on a yearly basis to ensure that clinicians have access to the most current data available on device performance. At a minimum, these updates will include for the pivotal study cohort a summary of the number of patients for whom data are available, with the rates of aneurysm rupture, conversion to surgical repair, aneurysm-related death, all-cause mortality, endoleak, aneurysm enlargement, prosthesis migration, and patency. Reports of losses of device integrity, reasons for conversion, and summaries of information obtained through analyses of explanted devices are to be described. Additional relevant information from commercial experience within and outside of the United States will also be included. As with the original labeling, the annual clinical updates will be summaries of the relatively extensive amount of data reviewed by the FDA. Through these clinical updates, the FDA facilitates the ability of clinicians to determine the treatment of choice for individual patients. This can only be done after a treatment option becomes available, that is, after FDA approval of the device. Acknowledgment of these slightly different roles in ensuring patient welfare clarifies the value of such regulatory requirements, and in particular the ongoing role of the FDA in device monitoring after initial approval. Other offices in the Center for Devices and Radiological Health have important responsibilities in the From the Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Md. Competition of interest: none. The views and opinions in this article are those of the author and do not necessarily reflect those of the US FDA, the US Department of Health and Human Services, or the Public Health Service. Reprint requests: Dorothy B. Abel, Center for Devices and Radiological Health, Food and Drug Administration, 9200 Corporate Blvd, Rockville, MD 20850 (e-mail: dba@cdrh.fda.gov). J Vasc Surg 2003;37:902-3. Copyright © 2003 by The Society for Vascular Surgery and The American Association for Vascular Surgery. 0741-5214/2003/$30.00 0 doi:10.1067/mva.2003.312