Manufacturer evaluations of endograft modifications.

The motivation to modify the design of a vascular device can arise from a number of sources. Clinical experience with the unmodified device could suggest new design modifications to improve device performance or clinical outcomes. Similarly, clinical success with a device often suggests modifications that could broaden the applicability of the device to enable treatment of different or more advanced disease states. As a specific example, both of these scenarios have arisen during the last decade in the evolution of endovascular grafts for the treatment of abdominal aortic aneurysms, with modifications enabling the treatment of patients with shorter infrarenal necks, more angulated anatomy, and smaller access vessels. These modifications have been made by manufacturers and additionally by physicians who create branched and fenestrated devices. The experience to date with the use of fenestrated devices and the development of chimney, snorkel, and periscope techniques suggests that modifications to off-the-shelf devices may provide some clinical benefit. This experience provides additional motivation for manufacturers to develop devices to address the clinical needs not met with their current product lines. For manufacturers, the device development process includes an assessment of the new device design to determine the appropriate evaluation strategy to support the safety and effectiveness of the modified device. This report provides a high-level overview of the process generally followed by device manufacturers to evaluate a proposed device modification before market release, in accordance with local country regulations and recognized international standards such as the International Organization of Standardization (ISO) standards for endovascular grafts (ISO 25539 Part 1).