Endurant II Stent Graft

The Endurant II/Endurant IIs bifurcated stent grafts are indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. They may be utilized in conjunction with the Heli-FX EndoAnchor System when augmented radial fixation and/or sealing is required; in particular, in the treatment of abdominal aortic aneurysms with short (≥ 4 mm and < 10 mm) infrarenal necks. The Endurant II Stent Graft System aorto-uni-iliac (AUI) stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms in patients whose anatomy does not allow the use of a bifurcated stent graft. The Endurant II/IIs Stent Graft System is indicated for use in patients with the following characteristics:

• Adequate iliac or femoral access that is compatible with vascular access techniques, devices, or accessories
• Proximal neck length of
• ≥ 10 mm; or
• ≥ 4 mm and < 10 mm when used in conjunction with the Heli-FX EndoAnchor System (bifurcated stent graft only)

Note: Neck length is defined as the length over which the aortic diameter remains within 10% of the infrarenal diameter.

• Infrarenal neck angulation of ≤ 60°
• Aortic neck diameters with a range of 19 to 32 mm
• Distal fixation length(s) of ≥ 15 mm
• Iliac diameters with a range of 8 to 25 mm
• Morphology suitable for aneurysm repair

CONTRAINDICATIONS

The Endurant II/Endurant IIs stent graft system is contraindicated in:

• Patients who have a condition that threatens to infect the graft
• Patients with known sensitivities or allergies to the device materials

When used with the Heli-FX EndoAnchor system, the Endurant II/IIs stent graft system is also contraindicated in:

• Patients with known sensitivities to the EndoAnchor implant materials

For contraindications regarding ancillary devices used with the Endurant II/Endurant IIs stent graft system, refer to the Instructions for Use provided with the device.

ENDURANT II STENT GRAFT FEATURES

1. Flexibility and conformability. Designed to conform to the natural tortuosity of the vessel. Low-profile, hydrophilic delivery coating enhances access and trackability.
2. Accurate placement and controlled deployment. Flexible, kink-resistant delivery system facilitates stent graft delivery. Tip capture for precise positioning adjustments, including adjustment of placement proximally or distally.
3. Optimal seal and fixation. M-shaped proximal stents provide wall apposition and minimize in-folding. Suprarenal stent anchor pins provide secure fixation.
4. Durability and strength. High-density, multifilament polyester graft material provides lower porosity for resistance against aneurysm sac growth.

DELIVERY AND DEPLOYMENT

The Endurant II delivery system helps ensure precise control and accurate placement at every stage of deployment:

• 100% PEVAR delivery and deployment success
• 99.3% delivery and deployment success

Tip capture delivery allows precise adjustment of position, proximally or distally, even after deployment of three stent rings. Control the release of the suprarenal stent and anchor pins with the back-end thumb wheel.

Endurant II Delivery System Controlled Deployment
Deployment, capture, and release of the Endurant II stent.