Single-Center Experience of Fenestrated Endovascular Aortic Repair Using Physician-Modified Endovascular Grafts Prior to Initiation of an Investigation Device Exemption Trial

Abstract

Fenestrated endovascular aortic repair (FEVAR) is an important option for complex abdominal aortic aneurysms (AAAs) and thoracoabdominal AAAs in patients high-risk for open repair. While availability of custom-devices is limited, physician-modified endografts (PMEGs) allow surgeons to build grafts for patients’ specific anatomy. Here, we present our PMEG experience, submitted to the US Food and Drug Administration with an Investigation Device Exemption trial application, which is now enrolling (clinicaltrials.gov NCT04746677).