Worldwide experience with the Endurant Stent-graft System: Review of the literature

Abstract

The Endurant Stent-graft System (Medtronic Vascular, Santa Rosa, CA, USA) is a next-generation device intended to expand the applicability of endovascular aortic repair (EVAR). To date, the Endurant has been evaluated in 9 short- and intermediate-term studies, several in patients presenting with challenging aneurysm anatomies. Consistently, the device in these studies has been shown to be safe and effective, with an excellent rate of deployment success and with very low rates of type I/III endoleaks and reinterventions. Single-center experience with the Endurant in high-risk patients with challenging anatomies, such as short kinked necks and calcified angulated iliac arteries, shows promising early results with no differences in mortality, morbidity, and reintervention rates compared to those of low-risk patients. But caution is warranted for application of the Endurant outside of the instructions for use. The Endurant StentGraft Natural Selection Global Postmarket Registry (ENGAGE) is a long-term 1266-patient 80-site worldwide prospective postmarket study initiated to augment the knowledge base (poolable and comparable) about EVAR in a real-world population implanted with the Endurant. Technical and clinical data for ENGAGE patients will be reported through the expected completion of 5-year follow-up for all ENGAGE registry patients in 2018. We discuss the evolving challenges for EVAR that the Endurant and other next-generation stent-grafts are designed to address and review outcomes published with the Endurant since the CE marking of the device in July 2008.