Medtronic Launches Stent Graft System in U.S.

Minneapolis, Minn.-based Medtronic has launched its Endurant II AAA (abdominal aortic aneurysm) stent graft system in the United States, which recently received U.S. Food and Drug Administration (FDA) approval for the minimally invasive treatment of AAAs through endovascular repair (EVAR), an alternative to major surgery. The system received the CE Mark in December 2011, and was released in Europe shortly afterward.

An AAA is a condition in which the aorta bulges or weakens, often with no apparent symptoms. An untreated AAA can rupture unexpectedly, which often results in sudden death, making this condition known as a “silent killer” and the third leading cause of sudden death in men older than age 60.

The Endurant II is a second-generation version of the original Endurant system, which received FDA approval in December 2010. The new system adds the following features to its capabilities:

• A lower profile delivery system with an extended hydrophilic coating improves access. The 28 mm-diameter stent graft (the most commonly used size) now fits inside an 18-French outer diameter catheter (down from 20 French in the original device);
• Two new contralateral limb lengths (156 mm and 199 mm) provide more options in sizing and can reduce the number of pieces required for an EVAR case; and
• improved radiopacity of the contralateral gate on the distal end of the device aids with limb insertion, placement and deployment.

“The Endurant II Stent Graft is a very deliverable device that enhances the ability to treat more patients than previous devices and to traverse challenging anatomies, especially iliac arteries with tight access,” said William Jordan, M.D., professor and chief of vascular surgery and endovascular therapy at the University of Alabama and one of the principal investigators for the U.S. clinical study of the predicate device. “Considering the exceptional clinical performance of the original system, the Endurant II Stent Graft is even easier to use in both straightforward and challenging anatomies.”

FDA approval of the Endurant II AAA Stent Graft is based on the results of the U.S. clinical study of the predicate device, which—according to the company—continues to demonstrate strong clinical performance and efficacy in long-term follow-up. The outcomes at two years showed no Type I endoleaks, migration, conversion to surgery, or aneurysm-related mortality. Furthermore, aneurysm sac diameter decreased or remained stable in 98.3 percent of patients at two years, Medtronic reported.