Single-Center Experience of Fenestrated Endovascular Aortic Repair Using Physician-modified Endovascular Grafts Before Initiation of an Investigation Device Exemption Trial

Abstract

Fenestrated endovascular aneurysm repair (FEVAR) is an important option for complex abdominal aortic aneurysms (AAAs) and thoracoabdominal aneurysms in patients high-risk for open repair. Currently, the only US Food and Drug Administration (FDA)-approved fenestrated device is limited to juxtarenal AAAs. Custom-manufactured devices are only available at a handful of US centers. Physician-modified endografts (PMEGs) allow surgeons to build grafts for patients’ anatomy using standard stent grafts. Here, we present our single-center experience with PMEGs, submitted to the FDA with an Investigation Device Exemption trial application, which is now approved and enrolling (clinicaltrials.gov NCT04746677).