Endurant II Stent Graft Systems

U.S. INDICATIONS

All indications related to Endurant II/IIs Stent Graft System are not approved globally.  Please check your local regulatory approval status.  Refer to the complete Instructions for Use manual of the Endurant II/IIs stent graft system for the indications approved in your geography.

The Endurant II/IIs stent graft system is indicated for the endovascular treatment of infrarenal or juxtarenal abdominal aortic or aortoiliac aneurysms in patients with the following characteristics:

• adequate iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices, or accessories
• iliac distal fixation length of ≥15 mm
• iliac diameters with a range of 8 to 25 mm
• morphology suitable for aneurysm repair 
• one of the following:
  • aneurysm diameter >5 cm
  • aneurysm diameter of 4 to 5 cm, which has also increased in size by 0.5 cm in the last 6 months
  • aneurysm that is at least 1.5 times the diameter of the normal infrarenal aorta

In addition, for treatment of infrarenal abdominal aortic or aortoiliac aneurysms, the following patient characteristics apply:

• aortic neck diameters with a range of 19 to 32 mm
• proximal neck length of ≥10 mm or ≥4 mm and <10 mm when used in conjunction with the Heli-FX EndoAnchor system, with insignificant calcification, or insignificant thrombus with ≤60° infrarenal and ≤45° suprarenal angulation and a vessel diameter approximately 10% to 20% smaller than the labeled Endurant II/Endurant IIs stent graft diameter
• proximal neck length of ≥15 mm with insignificant calcification, or insignificant thrombus with ≤75° infrarenal and ≤60° suprarenal angulation and a vessel diameter approximately 10% to 20% smaller than the labeled Endurant II/Endurant IIs stent graft diameter

In addition, for treatment of juxtarenal abdominal aortic or aortoiliac aneurysms with the parallel graft technique, the following patient characteristics apply:

• aortic neck diameters with a range of 19 mm to 30 mm
• infrarenal proximal neck length of ≥2 mm and total available proximal seal length >15 mm with a balloon expandable covered stent deployed in a parallel graft technique in one or two renal arteries and with insignificant calcification, or insignificant thrombus with ≤60° infrarenal, ≤45° suprarenal, and ≤45° suprasuperior mesenteric artery angulation (supraSMA angulation) and an aortic diameter approximately 20% to 30% smaller than the labeled Endurant II/Endurant IIs stent graft diameter 
• adequate brachial or axillary access that is compatible with vascular access techniques, devices, or accessories
• sufficient renal fixation length
• renal take off angulation <90° relative to the aortic centerline

Note: The angle between the aortic and renal artery blood lumen centerlines is the renal take-off angulation. An angle of <90° is associated with a downward-pointed renal artery relative to the trajectory of the aortic centerline.

Endurant II/IIs Stent Graft Product Features

Endurant II Family of Products

The Endurant II family:

• Includes Endurant II, Endurant II AUI and Endurant IIs stent grafts
  
• Designed to meet a wide range of patient anatomies
• Utilizes the Endurant II delivery system, which allows for accurate placement and controlled deployment

Endurant IIs stent graft is a three-piece system that:

• Leverages the proven design of the leading Endurant II abdominal stent graft
• Expands anatomical customization options
• Offers a shorter ipsilateral leg for more flexible, targeted limb placement
• Features equal leg diameters to allow limbs to be used on either side
• Utilizes the existing delivery system allowing accurate placement and controlled deployment

The Endurant IIs stent graft:

• Provides up to a 20% reduction in distal diameter compared to select Endurant II bifurs
• Enables in situ sizing with select ipsilateral limbs, allowing a 3-5 stent overlap for adjustment during case
• Allows easier pre-case planning to simplify sizing

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.

^* Data on file at Medtronic.

^† Bench test data on file at Medtronic. Bench test data may not be indicative of clinical performance.

^‡ Data on file from the 178 de novo patients from the ENGAGE Post-Approval Study (PAS).

^§ Delivery success = successful vascular access and delivery of the device to the intended anatomical treatment site. Deployment success = successful deployment of the device in the intended site and the successful removal of the delivery system. Endurant™ US IDE trial: Makaroun M. One-year outcomes of the US regulatory trial of the Endurant™ stent graft system. J Vasc Surg. 2011; 54:601–608.

Model Specifications

^* The limb mates with the AUI stent graft on the ipsilateral side.

^† These calculations assume the minimum 30 mm overlap between the bifurcated stent graft and the contralateral iliac limb per the Endurant II Stent Graft System Instructions For Use. When using the 124 mm length bifurcated stent graft, subtract 10 mm from Total Contralateral Covered Length with Bifurcated.

^‡ The 3-5 stent overlap is available only with select limbs. Please refer to the Instructions For Use for more information.