Medtronic, Inc. is showcasing its newly approved stent graft at this weekend’s Vascular Annual Meeting, taking place in San Francisco. The company has gained FDA approval for the Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System and the FDA 510(k) clearance for the Sentrant Introducer Sheath
The Endurant II AUI Stent Graft System is the only FDA-approved AUI device 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.
As with the bifurcated Endurant II Stent Graft, distinguishing features of the Endurant II AUI Stent Graft include a low delivery profile, tip capture for easy and accurate deployment and compatibility with contralateral iliac limbs and aortic extensions for ultimate patient applicability.
Whereas use of the bifurcated device requires access to both iliac arteries, the AUI device requires access to only one iliac artery.
“The new Endurant II Aorto-Uni-Iliac Stent Graft extends the proven performance of the Endurant System to patients with difficult access,” said Dr. Michel Makaroun, 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.”
The Sentrant Introducer Sheath
The second highlighted product, Medtronic’s Sentrant Introducer Sheath complements the company’s market-leading portfolio of stent grafts for endovascular aortic repair. It is specially designed for use with the Endurant II AAA and Valiant Captivia Stent Graft Systems and is also compatible with competitive 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 enable smooth passage of the stent graft delivery system en route to the treatment site in the aorta.
The Sentrant Introducer Sheath can accommodate a wide range of anatomies, with diameters of 12-26 French and shaft lengths of 28cm. Other distinguishing features of the accessory device include 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.