Medtronic announced on 12 November 2014 the launch in Europe and the United States of the Endurant IIs AAA stent graft, which recently received the CE mark and FDA approval to be used in the minimally invasive treatment of abdominal aortic aneurysms.
According to the company, the Endurant IIs stent graft is a new bifurcated component for the system that leverages the proven design of the predicate device and expands the system’s anatomical customisation 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, offers a shorter (50mm) ipsilateral leg for more flexible targeted limb placement, enables in situ sizing with select ipsilateral limbs, allowing a 3–5 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 an integral part of the product portfolio and already 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.
“Every abdominal aortic aneurysm patient has different anatomical features, which is why it is so important for a stent graft system to provide for a wide variety of anatomical customization options,” explained William Jordan Jr, professor of surgery and chief of vascular surgery and endovascular therapy at the University of Alabama Birmingham, USA. “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.”
“The new Endurant IIs stent graft gives a winning idea new legs,” added Hence Verhagen, chief of vascular surgery at the Erasmus Medical Center in Rotterdam, The Netherlands. “It stands to broaden the already broad appeal of the Endurant system, especially for physicians who prefer a three-piece configuration for EVAR.”
Both Verhagen and Jordan have played important roles in studying the Endurant AAA stent graft system––Verhagen as a principal investigator in the European study that supported the CE mark and Jordan as an investigator in the US study for FDA approval.