“Off-IFU” Results of the Zenith Fenestrated Platform Are Comparable to Clinical Trial Outcomes

Abstract

The Zenith fenestrated device (ZFEN; Cook Medical, Bloomington, Ind) has been proved safe and effective in the treatment of short-neck abdominal aortic aneurysms. The indications for use (IFU) anatomic criteria include a neck length >4 mm, neck diameter <31 mm, aortic neck angle <45°, and nonaneurysmal common iliac arteries (<21 mm). The present study compared the safety of “off-IFU” use of the ZFEN compared with the original USFT (U.S. fenestrated trial) data and identified risk factors for failure.