FDA paves way for stent graft system, sheath

The FDA approved Medtronic’s Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System and gave 510(k) clearance for the Sentrant Introducer Sheath.

The stent graft system is 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. According to Minneapolis-based Medtronic, it features a low delivery profile, tip capture and compatibility with contralateral iliac limbs and aortic extensions.

The sheath is used with the Endurant II AAA and Valiant Captivia Stent Graft Systems and is compatible with other systems. It is designed to facilitate the implant procedure and enable passage of the stent graft delivery system from an access site in the patient’s femoral artery to the treatment site in the aorta. It can accommodate a range of anatomies.