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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.

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 Stent Products

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.
Endurant II Stent Graft Features

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.
Maggiori informazioniLess information (see less)

Deployment of the Endurant II Stent Graft

View an animation of the Endurant II stent deployment.
Maggiori informazioniLess information (see less)

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.

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 Endurant II/IIs System Sizing Sheet (.pdf)

Use this tool to plan case specifics such as sizing and placement.

714KB

ORDERING INFORMATION: ENDURANT II bifurcated devices

  Proximal
Graft
Diameter
(mm)
Distal
Graft
Diameter
(mm)
Distal
Design
Total
Covered
Length
(mm)
Delivery
System
Catheter
Outer
Diameter
(F)
ETBF  23 13 C 124 EE 18
ETBF  23 13 C 145 EE 18
ETBF  23 13 C 166 EE 18
ETBF  23 16 C 124 EE 18
ETBF  23 16 C 145 EE 18
ETBF  23 16 C 166 EE 18
ETBF  25 13 C 124 EE 18
ETBF  25 13 C 145 EE 18
ETBF  25 13 C 166 EE 18
ETBF  25 16 C 124 EE 18
ETBF  25 16 C 145 EE 18
ETBF  25 16 C 166 EE 18
ETBF  28 13 C 124 EE 18
ETBF  28 13 C 145 EE 18
ETBF  28 13 C 166 EE 18
ETBF  28 16 C 124 EE 18
ETBF  28 16 C 145 EE 18
ETBF  28 16 C 166 EE 18
ETBF  28 20 C 124 EE 18
ETBF  28 20 C 145 EE 18
ETBF  28 20 C 166 EE 18
ETBF  32 16 C 124 EE 20
ETBF  32 16 C 145 EE 20
ETBF  32 16 C 166 EE 20
ETBF  32 20 C 124 EE 20
ETBF  32 20 C 145 EE 20
ETBF  32 20 C 166 EE 20
ETBF  36 16 C 145 EE 20
ETBF  36 16 C 166 EE 20
ETBF  36 20 C 145 EE 20
ETBF  36 20 C 166 EE 20

 

ORDERING INFORMATION: Endurant IIs bifurcated devices

  Proximal
Graft
Diameter
(mm)
Distal
Graft
Diameter
(mm)
Distal
Design
Total
Covered
Length
(mm)
Delivery
System
Catheter
Outer
Diameter
(F)
ESBF  23 14 C 103 EE 18
ESBF 25 14 C 103 EE 18
ESBF 28 14 C 103 EE 18
ESBF 32 14 C 103 EE 20
ESBF 36 14 C 103 EE 20

ORDERING INFORMATION: LIMBS*

 

Distal

Graft
Diameter
(mm)

Distal
Graft
Diameter
(mm)
Distal
Design
Total
Covered
Length
(mm)
Delivery
System
Catheter
Outer
Diameter
(F)
Total
Contralateral
Covered
Length with
EII/EIIs
Bifurcated
Total
Ipsilateral
Covered
Length with
EIIs
Bifurcated
ETLW 16 10 C 82 EE 14 136 155
ETLW 16 10 C 93 EE 14 147 166
ETLW 16 10 C 124 EE 14 178 177-197
ETLW 16 10 C 156 EE 16 210 209-229
ETLW 16 10 C 199 EE 16 253 252-272
ETLW 16 13 C 82 EE 14 136 155
ETLW 16 13 C 93 EE 14 147 166
ETLW 16 13 C 124 EE 14 178 177-197
ETLW 16 13 C 156 EE 16 210 209-229
ETLW 16 13 C 199 EE 16 253 252-272
ETLW 16 16 C 82 EE 14 136 135-155
ETLW 16 16 C 93 EE 14 147 146-166
ETLW 16 16 C 124 EE 14 178 177-197
ETLW 16 16 C 156 EE 16 210 209-229
ETLW 16 16 C 199 EE 16 253 252-272
ETLW 16 20 C 82 EE 16 136 155
ETLW 16 20 C 93 EE 16 147 166
ETLW 16 20 C 124 EE 16 178 177-197
ETLW 16 20 C 156 EE 16 210 209-229
ETLW 16 20 C 199 EE 16 253 252-272
ETLW 16 24 C 82 EE 16 136 155
ETLW 16 24 C 93 EE 16 147 166
ETLW 16 24 C 124 EE 16 178 177-197
ETLW 16 24 C 156 EE 16 210 209-229
ETLW 16 24 C 199 EE 16 253 252-272
ETLW 16 28 C 82 EE 16 136 155
ETLW 16 28 C 93 EE 16 147 166
ETLW 16 28 C 124 EE 16 178 177-197
ETLW 16 28 C 156 EE 16 210 209-229
ETLW 16 28 C 199 EE 16 253 252-272

* 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.

ORDERING INFORMATION: AORTIC EXTENSIONS

 

Proximal

Graft
Diameter
(mm)

Distal
Graft
Diameter
(mm)
Distal
Design
Total
Covered
Length
(mm)
Delivery
System
Catheter
Outer
Diameter
(F)
ETCF  23 23 C 49 EE 18
ETCF  25 25 C 49 EE 18
ETCF  28 28 C 49 EE 18
ETCF  32 32 C 49 EE 20
ETCF  36 36 C 49 EE 20

 

ORDERING INFORMATION: ABDOMINAL TUBES

  Proximal
Graft
Diameter
(mm)
Distal
Graft
Diameter
(mm)
Distal
Design
Total
Covered
Length
(mm)
Delivery
System
Catheter
Outer
Diameter
(F)
ETTF 23 23 C 70 EE 18
ETTF 25 25 C 70 EE 18
ETTF 28 28 C 70 EE 18
ETTF 32 32 C 70 EE 20
ETTF 36 36 C 70 EE 20

ORDERING INFORMATION: ENDURANT II AUI

  Proximal
Graft
Diameter
(mm)
Distal
Graft
Diameter
(mm)
Distal
Design
Total
Covered
Length
(mm)
Delivery
System
Catheter
Outer
Diameter
(F)
ETUF 23 14 C 102 EE 18
ETUF 25 14 C 102 EE 18
ETUF 28 14 C 102 EE 18
ETUF 32 14 C 102 EE 20
ETUF 36 14 C 102 EE 20

ORDERING INFORMATION: ILIAC EXTENSIONS

  Proximal
Graft
Diameter
(mm)
Distal
Graft
Diameter
(mm)
Distal
Design
Total
Covered
Length
(mm)
Delivery
System
Catheter
Outer
Diameter
(F)
ETEW  10 10 C 82 EE 14
ETEW  13 13 C 82 EE 14
ETEW  20 20 C 82 EE 16
ETEW  24 24 C 82 EE 16
ETEW  28 28 C 82 EE 18