Medtronic, Inc. MDT is expanding its
market-leading portfolio of products for endovascular aortic repair in the
United States with two new medical devices: the company recently received
approval from the U.S. Food and Drug Administration (FDA) for the Endurant II
Aorto-Uni-Iliac (AUI) Stent Graft System and the FDA's 510(k) clearance for
the Sentrant Introducer Sheath; both devices will be on exhibit at the
Medtronic booth during the Society for Vascular Surgery's "Vascular Annual
Meeting," which runs May 30-June 2 in San Francisco.
Endurant II AUI Stent Graft System
The Endurant II AUI Stent Graft System is the only FDA-approved AUI device in
the United States indicated for the primary endovascular treatment of
infrarenal abdominal aortic or aorto-iliac aneurysms in patients whose anatomy
does not allow for the use of a bifurcated device. Both the bifurcated and AUI
configurations of the Endurant Stent Graft System provide a new pathway for
blood flow through the iliac arteries in abdominal aortic aneurysms, thereby
reducing risk of aneurysm rupture.
Whereas use of the bifurcated device requires access to both iliac arteries,
the AUI device requires access to only one iliac artery. In published studies
of endovascular abdominal aortic aneurysm (AAA) repair, current global usage
of AUI stent graft configurations averages 5 percent (range 0-26%) for intact
AAA and 39 percent (range 0-91%) for ruptured AAA.
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