Medtronic Wins 501(K) Clearance for Sentrant Introducer Sheath

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.