Medtronic Bifurcated Endurant IIs AAA Stent Graft Launched in Europe and United States

November 12, 2014—Medtronic, Inc. announced the launch in Europe and the United States of the Endurant IIs abdominal aortic aneurysm (AAA) stent graft, which recently received European CE Mark approval and US Food and Drug Administration (FDA) approval for the minimally invasive treatment of AAAs.

According to the company, the Endurant IIs stent graft is a new bifurcated component for Medtronic’s Endurant stent graft system that leverages the design of the predicate device and expands the system's anatomical customization options. The new device is designed to be used as part of a three-piece configuration.

The Endurant IIs stent graft features equal leg diameters to allow limbs to be used on either side. Additionally, the device offers a shorter (50 mm) ipsilateral leg for more flexible targeted limb placement; enables in situ sizing with select ipsilateral limbs, allowing a three- to five-stent overlap for adjustment during the implant procedure; provides up to a 20% reduction in distal diameter compared to select Endurant II stent grafts; and allows easier pre-case planning by simplifying sizing decisions.

The new device complements the existing Endurant II stent graft, which remains a part of the product portfolio and accommodates a wide range of anatomies. The Endurant II and Endurant IIs stent grafts use the same delivery system, which allows for accurate placement and controlled deployment of the device within the aorta.

In the company’s announcement, William Jordan Jr, MD, commented, “Every AAA patient has different anatomical features, which is why it's so important for a stent graft system to provide for a wide variety of anatomical customization options. The Endurant stent graft system sets the standard for configuration possibilities, and the addition of the Endurant IIs stent graft expands the possibilities even further.” Dr. Jordan is professor of surgery and chief of vascular surgery and endovascular therapy at the University of Alabama Birmingham. Dr. Jordan served as an investigator in the United States study of the Endurant IIs that supported FDA approval.

Prof. Hence Verhagen, MD, added, “The new Endurant IIs stent graft gives a winning idea new legs. It stands to broaden the already broad appeal of the Endurant system, especially for physicians who prefer a three-piece configuration for EVAR.” Prof Verhagen is chief of vascular surgery at the Erasmus Medical Center in Rotterdam, the Netherlands. Prof. Verhagen served as a principal investigator in the European study that supported CE Mark approval of the Endurant IIs.