Healthcare Professionals

Endurant II Stent Graft Systems

EVAR Procedures

Overview

Choose the AAA proven solution as varied as your patients. The Endurant™ II system family of products provides the standard of care with a legacy of clinical success for the treatment of abdominal aortic aneurysm (AAA). For the past 5 years, the Endurant II stent graft system has been used in 1 out of 2 EVAR cases.* Only the Endurant II stent graft has the deep clinical experience and favorable clinical outcomes designed to treat both straightforward and challenging anatomy.

Indications

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

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, AUI, and Endurant II product images on a white background

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 precase 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.
Illustration showing Endurant II stent graft features close up

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.

Endurant II Controlled Deployment

Deployment of the Endurant IIs Stent Graft

View an animation of the Endurant IIs stent graft deployment.
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Deployment of the Endurant II Stent Graft

View an animation of the Endurant II stent deployment.
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Manuals and Technical Guides

Instructions for Use
Find this technical manual in the Medtronic Manual Library, in the product labeling supplied with each device, or by calling 877-526-7890.

Model Specifications

pdf Sizing Sheet and Ordering Information (.pdf)

Use this tool to plan case specifics, such as sizing and placement. See model specs including stent graft lengths, diameters, and crossing profiles.

844KB

View Specifications
*

Data on file at Medtronic.

As of December 2017.

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).

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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.