Medtronic’s AUI device with Endurant II AAA stent graft system receives FDA approval

30 May 2013 (Last Updated May 30th, 2013 18:30)

US-based Medtronic is widening its portfolio of products for endovascular aortic repair in the US with two new medical devices following the FDA approval for the Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System and recent 510(k) clearance for the Sentrant Introducer Sheath.

US-based Medtronic is widening its portfolio of products for endovascular aortic repair in the US with the FDA approval of the Endurant II Aorto-Uni-Iliac (AUI) stent graft system and recent 510(k) clearance for the Sentrant introducer sheath.

Currently, the Endurant II AUI stent graft system is said to be the only FDA-approved AUI device in the country that is designed for the primary endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms in patients whose anatomy does not permit the use of a bifurcated device.

The system's bifurcated and AUI configurations offer a new pathway for blood flow through the iliac arteries in abdominal aortic aneurysms, thereby minimising the risk of aneurysm rupture.

Studies of endovascular abdominal aortic aneurysm (AAA) repair show that the present worldwide usage of AUI stent graft configurations averages 5% (range 0-26%) for intact AAA and 39% (range 0-91%) for ruptured AAA.

Distinguishing features of the Endurant II AUI stent graft comprise a low delivery profile, tip capture for easy and accurate deployment and compatibility with contralateral iliac limbs and aortic extensions for patient applicability.

"The Endurant II AUI system's bifurcated and AUI configurations offer a new pathway for blood flow through the iliac arteries in abdominal aortic aneurysms, thereby minimising the risk of aneurysm rupture."

University of Pittsburgh Medical Center chief of vascular surgery Dr Michel Makaroun said that the new AUI stent graft extends the proven performance of the Endurant system to patients with difficult access.

"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," Makaroun said.

The company's other device, Sentrant introducer sheath, complements the portfolio of stent grafts for endovascular aortic repair.

Designed for use with the Endurant II AAA and Valiant Captivia stent graft systems, it is also compatible with competor's systems.

The Sentrant introducer sheath is inserted at the access site in the patient's femoral artery and advanced upwards into the iliac arteries to facilitate the implant procedure, and allows smooth passage of the stent graft delivery system en-route to the treatment site in the aorta.

It can accommodate a range of anatomies, with diameters of 12-26 French and shaft lengths of 28cm.

The distinguishing features of this device comprise optimal seal for superior hemostasis, reinforced coil for kink resistance, hydrophilic coating and flexibility for easy tracking through tortuous and calcified iliacs and a dilator locking mechanism for secure positioning.

The Sentrant introducer sheath received the CE mark in April 2013.