Medtronic Gains FDA Approval for Endurant II Aorto-Uni-Iliac Device, 510(k) Clearance for Sentrant Introducer Sheath

May 30, 2013—With the 2013 Vascular Annual Meeting underway in San Francisco, Medtronic Inc. (Minneapolis, MN) has announced the US Food and Drug Administration approval of its Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System and 510(k) clearance for its Sentrant Introducer Sheath.

After the landmark approval, Endurant II is indicated for primary endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms in patients whose anatomies do not allow for the use of a bifurcated device.

“The new Endurant II Aorto-Uni-Iliac Stent Graft extends the proven performance of the Endurant System to patients with difficult access,” said Michel Makaroun, MD, in the company's press release. Dr. Makaroun is Chief of Vascular Surgery at the University of Pittsburgh Medical Center and Co-Director of the UPMC Heart and Vascular Institute. “By maintaining the deliverability, conformability, and deployment accuracy of the bifurcated Endurant device, the AUI configuration offers aneurysm patients with challenging outflow anatomies a better option for a successful endovascular aortic repair.”

In its announcement, Medtronic cited a pair of studies by Ricotta et al showing that the current global usage of AUI stent graft configurations averages 5% (range, 0-26%) for intact abdominal aortic aneurysms (AAA) and 39% (range, 0-91%) for ruptured AAA.

Designed for use with Medtronic's Endurant II and Valiant Captivia Stent Graft Systems, the Sentrant Introducer Sheath is also compatible with competitive systems. Sentrant's cleared diameters range from 12 F to 26 F, with shaft lengths of 28 cm. Features of the Sentrant sheath include optimal seal, reinforced coil for kink resistance, a hydrophilic coating, flexibility, and a dilator locking mechanism for secure positioning. The introducer sheath received the CE Mark in April 2013.