Endurant™ II/IIs
Stent Graft System
Instructions for Use
Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party trademarks (“TM*”) belong to their respective owners. The
following list includes trademarks or registered trademarks of a Medtronic entity in the United States and/or in other countries.
Aptus™, EndoAnchor™, Endurant IIs™, Endurant II™, Endurant™, Heli-FX™, Pacific™, Reliant™, Talent™
EXPLANATION OF SYMBOLS ON PRODUCT LABELING
Refer to the device labeling to see which symbols apply to this product.
Contents: One Device
Do not use if package is damaged
Nonpyrogenic
Peel here
MR Conditional
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Sterilized using irradiation
Catalog number
Serial number
Use-by date
Do not reuse
Manufacturer
Manufactured in
Consult instructions for use at this website
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Contents
1 Device description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.1 Stent graft . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.2 Delivery system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.3 Heli-FX EndoAnchor system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2 Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4 Warnings and Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.2 Patient selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.3 Before the implant procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.4 During the implant procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4.5 Treatment and follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
4.6 MRI safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
5 Adverse events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
5.1 Observed adverse events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
5.2 Potential adverse events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
5.3 Device-related adverse events reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
6 Summary of clinical studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
6.1 Endurant stent graft system US clinical study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
6.2 ENGAGE PAS cohort . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
6.3 ANCHOR Registry short neck cohort . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
7 Patient selection and treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
7.1 Individualization of treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
8 Patient counseling information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
9 How supplied . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
9.1 Sterility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
9.2 Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
9.3 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
10 Clinical use information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
10.1 Physician training requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
10.2 Recommended device sizing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
10.3 Device inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
10.4 Additional required equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
10.5 Additional recommended equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
10.6 MRI information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
11 Implant instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
11.1 Vascular access and device preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
11.2 Delivery procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
12 Bail-Out Techniques . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
12.1 Screw gear handle disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
12.2 Ballooning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
12.3 Back-end handle disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
12.4 Snare the tapered tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
13 Follow-up imaging recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
13.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
13.2 X-ray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
13.3 CT with contrast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
13.4 Noncontrast CT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
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13.5 Duplex ultrasound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
13.6 MRI or MRA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
13.7 Imaging tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
13.8 Supplemental imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
14 Additional Surveillance and Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
15 Device registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
16 Disclaimer of Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
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1 Device description
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The Endurant II/Endurant IIs stent graft system (hereinafter referred to as Endurant II/IIs stent graft system) is intended to treat
infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach. When placed within the aneurysm, the stent
graft provides an alternative conduit for blood flow within the patient’s vasculature.
The stent graft system is comprised of 2 main components: the implantable stent graft and the disposable delivery system. The stent
graft is preloaded into the delivery system and advanced to the aneurysm using fluoroscopic guidance. Upon deployment, the stent
graft self-expands to conform to the shape and size of the seal zones above and below the aneurysm.
The Endurant II/IIs stent graft can also be used with the Heli-FX EndoAnchor system (available separately). The Heli-FX EndoAnchor
system is designed to provide fixation and augment sealing between the Endurant II/IIs stent graft and the native artery. The system
consists of an EndoAnchor implant that is delivered using the Heli-FX applier through the steerable Heli-FX guide.
1.1 Stent graft
There are 2 main body stent graft configurations: a bifurcated main body stent graft and an aorto-uni-iliac (AUI) main body stent graft.
First, a bifurcated device is implanted into the patient’s aorta. If a bifurcated device cannot be implanted, an AUI device can be used.
After placement of the bifurcated or AUI device, limb stent graft configurations are introduced separately into the vessel and mated
with the implanted main body stent graft configuration. Depending on the patient’s anatomy, a limb configuration may not be required
in the AUI configuration. If additional distal or proximal coverage is needed, an iliac or aortic extension configuration is introduced
separately into the vessel and mated with the implanted main body stent graft configuration.
All Endurant II/IIs stent graft configurations are composed of nitinol stents sewn to a fabric graft with nonresorbable sutures.
Radiopaque markers are sewn onto the stent graft to aid in visualization and to facilitate accurate placement. The nitinol stents may
also be visible under fluoroscopy.
Stent grafts should be oversized to be larger than the measured vessel inner diameter (aortic components are oversized
approximately 10–20%; limb components are oversized approximately 10–25%). Recommended device sizing (Section 10.2)
contains detailed sizing information for all stent graft components, including available ranges of length and diameter. Table 1 contains
a summary of the stent graft materials.
Figure 1. Stent graft configurations and locations of RO markers
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1 Radiopaque marker
2 ‘e’ marker
3 Radiopaque gate marker
4 Endurant II aortic extension configuration
5 Endurant II bifurcated configuration
Note: This and all other product graphics appearing in this manual are not drawn to scale.
Table 1. Stent graft materials
Component Material
Stents Nickel-titanium (nitinol) alloy
Button radiopaque markers Platinum-iridium alloy
“e” radiopaque marker Platinum
Contralateral gate marker Platinum-iridium alloy
Graft material Polyester
Suture Polyester and polyethylene
The Endurant II/Endurant IIs stent graft system does not contain natural rubber latex. However, during the manufacturing/assembly
process, it may have incidental contact with latex-containing products.
1.1.1 Bifurcated configuration
The bifurcated stent graft is available in 2 configurations: the Endurant II bifurcated configuration and the Endurant IIs bifurcated
configuration. The Endurant II bifurcated configuration is an aortoiliac stent graft that is available in 3 lengths. The Endurant IIs
bifurcated configuration is an aortic configuration available in a single, shorter length (Figure 1). The proximal end of both bifurcated
configurations deploy into the proximal neck and upper section of the aneurysm. The proximal end of the bifurcated configuration is
composed of nitinol stents sewn to a fabric graft. The suprarenal portion of the proximal end is not covered with graft fabric (Figure 1).
The suprarenal stent also contains anchor pins to fix the stent graft in place inside the aorta above the renal arteries without obstructing
them with graft fabric. The diameters of the available proximal aortic section of the bifurcated stent graft configurations range from
23 mm to 36 mm, and the covered length of the bifurcated stent graft configurations range from 124 mm to 166 mm (Endurant II
bifurcated stent graft) or 103 mm (Endurant IIs bifurcated stent graft). The aortic sections of the bifurcated stent graft configurations
should be oversized 10% to 20% in relation to the actual measured innervessel diameter. The available sizes can be used in aortas
with diameters ranging from 19 mm to 32 mm.
The aortic section bifurcates distally into 2 smaller tubes: an ipsilateral leg and a shorter contralateral leg. In the Endurant II bifurcated
configuration, all stents on the ipsilateral leg are sewn to the outside of the fabric creating a smooth inner lumen. In the Endurant IIs
bifurcated configuration, the 4 distal stents are sewn to the inside of the ipsilateral leg graft fabric. For all sizes, the stents on the
contralateral leg are sewn to the inside of the graft fabric (Figure 1). The Endurant II bifurcated stent graft configurations have an
ipsilateral leg that range in diameters from 13 mm to 20 mm and may be used in iliac arteries with diameters ranging from 10 mm to
18 mm. The Endurant II bifurcated stent graft configurations have a contralateral leg that range in diameters from 12 mm to 14 mm.
The Endurant IIs bifurcated stent graft ipsilateral and contralateral legs are available in 14 mm diameter and are not intended to extend
to the iliac arteries.
Note: The bifurcated configurations are always used with the limb configuration (Section 1.1.3).
6 Endurant IIs bifurcated configuration
7 Endurant II iliac extension configuration
8 Endurant II limb configuration
9 Endurant II aorto-uni-iliac configuration
10 Overlap marker
1.1.2 Aorto-Uni-Iliac (AUI) configuration
The AUI device is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms only in patients
whose anatomy does not allow the use of a bifurcated device. The proximal end of the aorto-uni-iliac (AUI) configuration is deployed
into the proximal neck and upper section of the aneurysm. The proximal section of the AUI configuration is composed of nitinol stents
sewn to a fabric graft. The suprarenal portion of the proximal end is not covered with fabric (Figure 1). The suprarenal stent includes
anchor pins to fix the stent graft in place inside the aorta above the renal arteries without obstructing them with graft fabric. The AUI
configurations are available in proximal diameters ranging from 23 mm to 36 mm, with a 102 mm covered length. The aortic sections
of the AUI configurations should be oversized 10% to 20% in relation to the actual measured inner vessel diameter. The available sizes
can be used in aortas with diameters ranging from 19 mm to 32 mm. For additional sizing information, see Recommended device
sizing (Section 10.2). Distally, the aortic section tapers down to a smaller diameter tube. In the distal end of the tapered AUI device,
the stents are sewn to the inside of the graft fabric (Figure 1). The distal end has a diameter of 14 mm.
Note: Depending on the patient’s anatomy, a limb configuration may not be required for all AUI device implantations.
Note: A femoral-femoral artery bypass may be performed in conjunction with implantation of the AUI device to maintain perfusion to
the contralateral femoral artery. In order to prevent backflow into the aneurysm sac, most patients will require occlusion of the iliac
artery. This may be accomplished through methods selected by the physician. The Talent occluder system (available separately) is
an optional component that is often used in conjunction with the AUI configuration. It is closed at both ends to stop retrograde blood
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flow into the aneurysm sac. For details on the Talent occluder system, refer to the instructions for use. If complete atherosclerotic
obstruction of the vessel is already present, occluding the iliac artery may not be necessary.
1.1.3 Limb configuration
The proximal end of the limb configuration deploys within the legs of the bifurcated configuration, while the distal end deploys into the
iliac artery. For the AUI device, the proximal end of the limb configuration deploys within the distal end of the AUI configuration while
the distal end deploys into the iliac artery on the ipsilateral side. The proximal end of the limb configuration has an open web
configuration, which contains no graft material in its stent valleys (Figure 1). The distal diameter of limb configurations range from
10 mm to 28 mm with lengths ranging from 82 mm to 199 mm. The proximal diameter is 16 mm for all sizes of limb configuration, so
they can dock with all available bifurcated stent graft configurations. The limb configuration should be oversized 10% to 25% in relation
to the inner vessel diameter and can be used in iliac arteries ranging from 8 mm to 25 mm.
Note: A limb device is implanted on both the ipsilateral and contralateral legs of an Endurant IIs bifurcated configuration. See Deploy
Limb Stent Graft Into Ipsilateral Leg (Endurant IIs bifurcated configuration only) (Section 11.2.14).
1.1.4 Iliac extension configuration
An iliac extension configuration is available if additional distal stent graft length is needed. It has an open web configuration on the
proximal section (Figure 1). The diameters of iliac extension configurations range from 10 mm to 28 mm with a covered length of
82 mm. Similar to the limb configuration, the iliac extension configuration is designed for oversizing 10% to 25% and can be used in
iliac arteries ranging from 8 mm to 25 mm in diameter.
Note: An appropriately sized limb configuration can be used as an iliac extension configuration.
1.1.5 Aortic extension configuration
An aortic extension configuration is available if additional proximal stent graft length is needed. The aortic extension stent graft has
a bare proximal suprarenal stent with anchor pins (Figure 1). The diameters of available aortic extension configurations range from
23 mm to 36 mm with the aortic extension having a covered length from 49 mm to 70 mm. Similar to the bifurcated and AUI
configurations, the aortic extension configuration is designed for oversizing of 10% to 20% in relation to the actual measured inner
vessel diameter. The available sizes can be used in aortas with diameters ranging from 19 mm to 32 mm.
1.2 Delivery system
The Endurant II delivery system, which delivers all stent graft configurations, consists of a single-use, disposable catheter with an
integrated handle to provide controlled deployment. It is available in 14, 16, 18, and 20 Fr graft cover diameters and a working length
of 57 cm ± 2 cm. The catheter assembly is flexible and compatible with a 0.035 in (0.89 mm) guidewire. There are 2 types of delivery
systems: the aortic (Figure 2) and the iliac (Figure 3) delivery systems. The aortic delivery system delivers the bifurcated, aortic
extension, and AUI configurations. The iliac delivery system delivers the limb and iliac extension stent graft configurations. The aortic
delivery system features a tip capture mechanism, which is not present in the iliac delivery system.
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Figure 2. Aortic delivery system
1 Rear handle
2 Back-end wheel
3 Screw gear
4 External slider
5 Trigger
6 Front grip
7 Graft cover
8 Markerband
9 Spindle
10 Sleeve
11 Tapered tip
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Figure 3. Iliac delivery system
1 Rear handle
2 Screw gear
3 External slider
4 Trigger
5 Front grip
6 Graft cover
7 Markerband
8 Tapered tip
1.3 Heli-FX EndoAnchor system
The Endurant II/IIs stent graft can also be used with the Heli-FX EndoAnchor system (available separately). The system consists of
an EndoAnchor implant that is delivered using the Heli-FX applier through the steerable Heli-FX guide. The EndoAnchor implant is
designed to provide fixation and augment sealing between the Endurant II/IIs stent graft and the native artery. The EndoAnchor
implant may be implanted at the time of the initial stent graft implantation or during a secondary (for example, repair) procedure.
Note: For additional information about using this system with the Endurant II/IIs stent graft, refer to Section 11.2.17 . For additional
information about the Heli-FX EndoAnchor system, refer to the instructions for use provided with the system.
2 Indications for use
The Endurant II/IIs bifurcated stent graft is 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 (see Neck
length definition below). The Endurant II 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 vessel morphology 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 of ≥15 mm
• Iliac diameters with a range of 8 to 25 mm
• Morphology suitable for aneurysm repair
10
3 Contraindications
The Endurant II/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 listed in Table 1
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/IIs stent graft system, refer to the instructions for use
provided with each device.
4 Warnings and Precautions
Caution: Read all instructions carefully. Failure to properly follow the instructions, warnings, and precautions may lead to serious
consequences or injury to the patient.
4.1 General
• The Endurant II/IIs stent graft system should only be used by physicians and teams trained in vascular interventional techniques,
including training in the use of this device. Specific training expectations are described in Physician Training Requirements
(Section 10.1).
• When the Endurant II/IIs stent graft system is used with the Heli-FX EndoAnchor system, it should only be used by physicians and
teams who are also trained in the use of the EndoAnchor system.
• The Heli-FX EndoAnchor system should be used 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.
• Always have a vascular surgery team available during implantation or reintervention procedures in the event that conversion to
open surgical repair is necessary.
4.2 Patient selection
• Inappropriate patient selection may result in poor device performance or device performance not otherwise in accordance with
the specifications.
• Do not use the Endurant II/IIs stent graft system in patients unable to undergo, or who will not be compliant with, the necessary
preoperative and postoperative imaging and implantation procedures (Chapter 10 to Chapter 13).
• The Endurant II/IIs stent graft system is not recommended in patients who cannot tolerate contrast agents necessary for
intraoperative and postoperative follow-up imaging.
• The Endurant II/IIs stent graft system is not recommended in patients exceeding weight or size limits necessary to meet imaging
requirements.
• Key anatomic elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation (>60°);
short proximal aortic neck (<10 mm) without use of the Heli-FX EndoAnchor system; very short proximal aortic neck (<4 mm); and
thrombus and/or calcium formation at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery
interface. Irregular calcification and/or plaque may compromise the fixation and sealing of the implantation sites. Necks exhibiting
these key anatomic elements may be more conducive to graft migration.
• Methodologies for measurement of neck length vary. Where neck length is defined as the length over which the aortic diameter
remains within 10% of the infrarenal diameter, other definitions may result in an estimation of neck length that is longer than that
obtained using this definition.
• Deploying the stent graft in an area of vessel calcification may lead to abrasion of the stent graft on calcified plaque, potentially
causing development of holes or tears in the graft.
• For infrarenal EVAR procedures using the Heli-FX EndoAnchor system:
– The access vessel diameter and morphology should be compatible for use with the Heli-FX EndoAnchor system.
– The EndoAnchor implant should be implanted only into areas of aortic tissue that are free of or have insignificant calcified
plaque or thrombus, or where such pathology is diffuse and less than 2 mm in thickness.
– Refer to the Heli-FX EndoAnchor system instructions for use for additional information.
• Iliac conduits may be used to ensure the safe insertion of the delivery system if the patient’s access vessels, as determined by
treating physician, preclude safe insertion of the delivery system.
• The long-term safety and effectiveness of the Endurant II/IIs stent graft system has not been established.
• The safety and effectiveness of the Endurant II/IIs Stent Graft System with the Heli-FX EndoAnchor system has not been
evaluated in an appreciable number of patients in ASA Class I-II.
• The safety and effectiveness of the Endurant II AUI device with the Heli-FX EndoAnchor system has not been evaluated.
11
• The safety and effectiveness of the Endurant II/IIs stent graft system has not been evaluated in patients who:
– Are less than 18 years old
– Are pregnant or lactating
– Have an aneurysm that is:
Suprarenal
Juxtarenal or pararenal
Isolated iliofemoral
Mycotic
Inflammatory
Pseudoaneurysm
– Have a dominant patent inferior mesenteric artery and an occluded or stenotic celiac or superior mesenteric artery
– Have an untreated thoracic aneurysm >4.5 cm in diameter
– Require emergent aneurysm treatment, eg, trauma or rupture
– Have a history of bleeding diathesis or coagulopathy
– Have had a myocardial infarction (MI) or cerebrovascular accident (CVA) within 3 months prior to implantation
– Have a reversed conical neck, which is defined as a >4 mm distal increase over a 10 mm length
– Have a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to
pre-treatment
– Have significant (typically >25% of vessel circumference of aortic neck and iliac artery, or >50% of the length of the iliac artery)
aortic mural thrombus at either the proximal or distal attachment location that would compromise bilateral fixation and seal of
the device
– Have ectatic iliac arteries requiring bilateral exclusion of hypogastric blood flow
– Have arterial access site that is not expected to accommodate the diameter of the device (14 to 20 Fr) due to size or tortuosity
– Have active infection at the time of the index procedure documented by pain, fever, drainage, positive culture, or leukocytosis
(WBC >11,000/mm3) that is treated with antimicrobial agents (nonprophylactic)
– Have congenital degenerative collagen disease
– Have congenital degenerative collagen disease, eg, Marfan’s Syndrome
– Have a creatinine >2.0 mg/dL
– Are on dialysis
– Have connective tissue disorder
• The safety and effectiveness of the Endurant II/IIs stent graft system with the Heli-FX EndoAnchor system has additionally not
been evaluated in patients who:
– have an infrarenal aortic neck with significant thrombus or calcium that precludes adequate EndoAnchor implant penetration
of the aortic wall
• All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess their health and the
performance of their endovascular graft. Patients with specific clinical findings (eg, endoleaks, enlarging aneurysms, or changes
in the structure or position of the endovascular graft), or less than the recommended number of EndoAnchor implants when used
in short proximal necks (≥ 4 mm and < 10 mm), should receive enhanced follow-up. Specific follow-up guidelines are described in
Chapter 13.
• Patients experiencing reduced blood flow through the graft limb or leaks may be required to undergo secondary interventions or
surgical procedures.
• Intervention or conversion to standard open surgical repair following initial endovascular repair should be considered for patients
experiencing enlarging aneurysms or endoleak. An increase in aneurysm size or persistent endoleak may lead to aneurysm
rupture.
• The AUI device should be used in patients whose anatomy does not allow the use of a bifurcated device. To maintain perfusion
to the contralateral limb, a femoral-femoral artery bypass may be performed. Timing of the femoral-femoral artery bypass is up to
the discretion of the physician.
• Reduced blood flow through the AUI device may lead to impairment of blood perfusion to the lower half of the body. The physician
should emphasize to the patient that graft occlusion can have life threatening consequences. The patient should be counseled
to seek medical attention immediately if he/she experiences pain in one or both legs, or if one or both legs become pale in color
and/or cool to the touch.
4.3 Before the implant procedure
• Preoperative planning for access and placement should be performed before opening the device packaging.
12
• Carefully inspect the Endurant II/IIs stent graft system packaging and device for damage or defects prior to use. Do not use product
if any sign of damage or breach of the sterile barrier is observed. Do not attempt to resterilize the delivery system or stent graft.
• Do not bend, kink, or otherwise alter the delivery system prior to implantation because it may cause deployment difficulties.
• To reduce the risk of thrombotic complications, an additional bolus of IV heparin should be administered before inserting the
device.
4.4 During the implant procedure
• Exercise care in handling and delivery technique to help prevent vessel rupture.
• Studies indicate that the danger of micro-embolization increases with increased procedure duration.
• Renal complications may occur:
– from an excess use of contrast agents
– as a result of embolic or misplaced stent graft
• Exercise care and utilize suitable imaging techniques when deploying the aortic endograft into a short proximal neck, to ensure
accurate placement. Inaccurate placement could result in unsuccessful implantation of EndoAnchor implants, the need to place
a proximal extension, or unintentional artery coverage.
• Do not deploy the stent grafts in a location that will cause an endoleak or occlude arteries necessary to supply blood flow to organs
or extremities. This could necessitate surgical removal of the device.
• Use fluoroscopic guidance to advance the delivery system, detect kinking, or assess alignment problems with the stent graft
devices. Do not use excessive force to advance or withdraw the delivery system when resistance is encountered. If the delivery
system kinks during insertion, do not attempt to deploy the stent graft. Remove the delivery system and insert a new one.
• Do not continue to torque the delivery system if the tip is not rotating with the delivery system.
• Exercise particular care in difficult areas, such as areas of stenosis, intravascular thrombosis, or in calcified or tortuous vessels.
Balloon angioplasty at the site of a narrowed or stenotic vessel may be considered prior to attempting to gently reintroduce the
catheter delivery system.
• An inadequate seal zone may result in increased risk of leakage into the aneurysm or migration of the stent graft.
• Systemic anticoagulation should be used during the implantation procedure based on hospital/physician protocol. If heparin is
contraindicated, an alternative anticoagulant should be considered.
• Stent grafts cannot be replaced or drawn back into the delivery system, even if only partially deployed.
• If the graft cover is accidentally withdrawn, the device will prematurely deploy and may be incorrectly positioned.
• For the limb stent graft overlap criteria with Endurant IIs ipsilateral leg only, please refer to Table 70. As noted in Table 70, for the
limb stent graft configurations that have an overlap criteria of 3 stents only, do not overlap more than 3 stents.
• When deploying the stent graft, be sure to hold the front grip of the delivery system stationary.
• If a balloon catheter is used, do not over-inflate or inflate outside the graft material. Follow all manufacturer instructions regarding
catheter operation.
• Expansion of the balloon outside of the graft material can result in rupture of the aorta, vessel dissection, or graft tears. When
expanding a vascular prosthesis, there is an increased risk of vessel injury or rupture, and possible patient death, if the balloon’s
proximal and distal radiopaque markers are not completely within the covered (graft fabric) portion of the prosthesis.
• High-pressure injections of contrast media made at the edges of the stent graft immediately after implantation can cause
endoleaks.
• For infrarenal EVAR procedures using the Heli-FX EndoAnchor system:
– Always use fluoroscopy for guidance, delivery, and observation of any Heli-FX system components within the vasculature.
– Medtronic recommends that the implantation of EndoAnchor implants be done after the aortic endograft has been placed and
any balloon remodeling of the infrarenal seal zone of the stent graft system has been completed. Exercise care in balloon
remodeling of the stent graft system to avoid moving the main body endograft from its intended implant location.
– EndoAnchor implant locations should be based upon a detailed examination of the preoperative CT imaging in cases involving
irregular or eccentric plaque in the intended sealing zone(s). The EndoAnchor implant should be implanted only into areas of
aortic tissue that are free of or have insignificant calcified plaque or thrombus, or where such pathology is diffuse and less than
2 mm in thickness. Attempting to place EndoAnchor implants into more severe plaque or thrombus may be associated with
implantation difficulty and suboptimal endograft fixation and/or sealing.
– The recommended number of EndoAnchor implants for a bifurcated endograft is based on native vessel diameter and is
independent of the amount of endograft oversizing.
– Stability of the stent graft in short (≥ 4 mm and < 10 mm) infrarenal necks is augmented by the EndoAnchor implants. Ensure
successful deployment of the recommended minimum number of EndoAnchor implants. Where the number of successfully
deployed EndoAnchor implants is below the minimum recommended, there may be greater risk of postoperative Type 1a
endoleak or migration.
13
4.5 Treatment and follow-up
• Any endoleak left untreated during the implantation procedure must be carefully monitored after implantation.
• All patients with endovascular aneurysm repair should undergo periodic imaging to evaluate the stent graft, aneurysm size, and
occlusion of vessels in the treatment area. Significant aneurysm enlargement (>5 mm), the appearance of a new endoleak,
evidence of perigraft flow, change in aneurysm pulsatility, or migration resulting in an inadequate seal zone should prompt further
investigation and may indicate the need for additional intervention or surgical conversion.
• Additional treatment including endovascular treatment or surgical conversion should be strongly considered in the following
cases:
– aneurysm growth >5 mm, with or without endoleak, since last follow-up
– change in aneurysm pulsatility, with or without growth or endoleak
– persistent endoleak, with or without aneurysm growth
– stent graft migration resulting in an inadequate seal zone
– decrease in renal function due to renal artery occlusion (migration or poor placement)
• Following endovascular aneurysm repair (EVAR), spinal cord ischemia (SCI) may result in a rare complication of paraplegia or
paraparesis. Cerebrospinal fluid (CSF) drain is advised if spinal cord ischemia is suspected.
4.6 MRI safety information
Nonclinical testing has demonstrated that the Endurant II/IIs stent graft system is MR Conditional. It can be scanned safely in both
1.5 T and 3.0 T MR systems only, with using only the specific testing parameters (Section 10.6). Additional MRI safety information is
found in Section 10.6. For additional MRI safety information about the Heli-FX EndoAnchor system, refer to the instructions for use
provided with the system.
5 Adverse events
5.1 Observed adverse events
Major adverse events observed in the clinical study supporting approval of the bifurcated device are provided in Table 2, Table 3, and
Table 24 (Section 6.1.1 and Section 6.2.1.11). Major adverse events observed in the clinical study supporting approval of the AUI
device are provided in Table 6, Table 7, and Table 42 (Section 6.1.2 and Section 6.2.2.11). Major adverse events observed in the
clinical evidence supporting approval of the short infrarenal neck indication are provided in Table 58 (Section 6.3.6.1).
5.2 Potential adverse events
Adverse events that may occur or require intervention include, but are not limited to:
• Amputation
• Anesthetic complications and subsequent attendant problems (eg, aspiration)
• Aneurysm enlargement
• Aneurysm rupture and death
• Aortic damage, including perforation, dissection, bleeding, rupture, and death
• Arterial or venous thrombosis or pseudoaneurysm
• Arteriovenous fistula
• Bleeding, hematoma, or coagulopathy
• Bowel complications (for example, ileus, transient ischemia, infarction, necrosis)
• Cardiac complications and subsequent attendant problems (for example, arrhythmia, myocardial infarction, congestive heart
failure, hypotension, hypertension)
• Claudication (for example, buttock, lower limb)
• Death
• Edema
• Embolization (micro and macro) with transient or permanent ischemia or infarction
• EndoAnchor (for infrarenal EVAR procedures using the Heli-FX EndoAnchor system): partial implant deployment, inaccurate
implant deployment, implant fracture, implant dislodgement, implant embolization, stent graft damage, modeling balloon damage
• Endoleak
• Femoral-femoral artery bypass thrombosis
• Fever and localized inflammation
• Genitourinary complications and subsequent attendant problems (for example, ischemia, erosion, fistula, incontinence,
hematuria, infection)
• Hepatic failure
14
• Impotence
• Infection of the aneurysm, device access site, including abscess formation, transient fever, and pain
• Lymphatic complications and subsequent attendant problems (eg, lymph fistula)
• Neurologic local or systemic complications and subsequent attendant problems (eg, confusion, stroke, transient ischemic attack,
paraplegia, paraparesis, paralysis)
• Occlusion of device or native vessel
• Pulmonary complications and subsequent attendant problems
• Renal complications and subsequent attendant problems (for example, artery occlusion, contrast toxicity, insufficiency, failure)
• Stent graft: improper placement; incomplete deployment; migration; suture break; occlusion; infection; stent fracture; graft
twisting or kinking; insertion and removal difficulties; graft material wear; dilatation; erosion; puncture and perigraft flow
• Surgical conversion to open repair
• Vascular access site complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula, dissection
• Vascular spasm or vascular trauma (for example, iliofemoral vessel dissection, bleeding, rupture, death)
• Vessel damage
• Wound complications and subsequent attendant problems (eg, dehiscence, infection, hematoma, seroma, cellulitis)
5.3 Device-related adverse events reporting
Any adverse event or clinical incident involving the Endurant II/IIs stent graft system or Heli-FX EndoAnchor system should be
immediately reported to Medtronic. To report an incident in the US, call (800) 465-5533.
6 Summary of clinical studies
The clinical evidence supporting the indications and safety and effectiveness of the Endurant II and Endurant IIs stent graft system is
described below:
Study Objective
Endurant Stent Graft System US Clinical Study Demonstrate that Endurant Bifurcated and Aorto-Uni-Iliac (AUI)
stent graft systems are safe and effective for the endovascular
treatment of infrarenal abdominal aortic or aortoiliac aneurysms.
ENGAGE Post Approval Study (PAS) The objective of the Post Approval Study Evaluating the Long
Term Safety And Effectiveness of the Endurant Stent Graft System (ENGAGE PAS) was to evaluate safety and effectiveness of
Endurant at 5 years through freedom from Aneurysm-Related
Mortality (ARM).
ANCHOR Registry – Short Neck Cohort To evaluate the safety and effectiveness of the Endurant
II/Endurant IIs Stent Graft System used in conjunction with the
Heli-FX EndoAnchor System in the endovascular treatment of
subjects with abdominal aortic aneurysms having an infrarenal
neck length of ≥ 4 mm and < 10 mm.
The premarket Endurant stent graft system US Clinical Study (Endurant US IDE Study; Section 6.1) was conducted on the Endurant
stent graft system, which is the previous version of the currently marketed Endurant II stent graft system and Endurant IIs stent graft
system. The Endurant II stent graft system and Endurant IIs stent graft system were approved without the submission of additional
clinical study data after enrollment for both the Endurant bifurcated and AUI study arms were completed using the original Endurant
stent graft system devices.
As a condition of approval, Medtronic conducted a post-approval study called the ENGAGE Post-Approval Study (PAS) to evaluate
the long-term safety and effectiveness of the Endurant stent graft system (Section 6.2).
The Endurant II stent graft system is based on design modifications to the previously approved Endurant stent graft system.
Specifically, the following changes were made to the Endurant stent graft system as part of the Endurant II stent graft system:
1. Use of the 18 Fr aortic delivery system to deliver the 28 mm aortic stent grafts (previously delivered using a 20 Fr delivery system
for Endurant stent graft system)
2. Addition of longer contralateral limbs (156 mm and 199 mm) to the portfolio and thereby increasing the overall length of the iliac
delivery system
15
3. Radiopaque (RO) marker changes:
a. addition of a button marker between the 3rd and 4th stent of the contralateral limb and iliac extension configurations
b. change to the material of the contralateral gate marker (from gold wire to coiled Platinum-Iridium (90%–10%))
c. change to the position of the contralateral stub button marker to the true lateral position
4. Increase in the hydrophilic coating length from 33.0 cm to 50.8 cm for the aortic and iliac delivery systems.
The design modifications for Endurant II were based on feedback from Endurant users. The primary design attributes of the Endurant
stent graft system were retained in the Endurant II stent graft system. The design changes were qualified through in vitro testing. Based
on the similarities of the Endurant II stent graft system to the Endurant stent graft system and the non-clinical testing, the clinical data
obtained on the Endurant stent graft system (Endurant US IDE Study and ENGAGE PAS) is applicable to the Endurant II stent graft
system as well.
The Endurant IIs stent graft system is based on the following design modifications made to the previously approved Endurant II stent
graft system:
1. Shorten the ipsilateral leg for consistent 103 mm of covered length.
2. Have a consistent ipsilateral and contralateral leg diameter of 14 mm.
3. Radiopaque (RO) marker addition on distal end of the ipsilateral leg.
4. Four distal stents are sewn internally in the ipsilateral leg.
5. Additional limb configuration is required to mate with ipsilateral leg.
Additionally, the Endurant II contralateral limb stent graft configuration was renamed the Endurant II limb stent graft configuration.
Medtronic utilized real-world evidence from the ANCHOR registry (Section 6.3) to establish the safety and effectiveness of Endurant
II/IIs stent graft system used in conjunction with Heli-FX in the treatment of abdominal aortic aneurysms (AAAs) with short infrarenal
necks (≥ 4 mm and < 10 mm).
6.1 Endurant stent graft system US clinical study
The Endurant stent graft system US Clinical Study (Endurant US IDE Study) was a controlled, prospective, two-arm (Bifurcated IDE
and AUI), non-randomized, multi-center clinical study to evaluate the safety and effectiveness of the Endurant stent graft system in the
treatment of infrarenal abdominal aortic and aortoiliac aneurysms. The Bifurcated IDE arm (Section 6.1.1) enrolled 150 subjects
across 26 sites in the United States. The AUI arm (Section 6.1.2) enrolled 44 subjects across 15 sites in the United States and Canada.
Subjects enrolled in the Bifurcated IDE and AUI arms were implanted with the original Endurant stent graft system.
The primary safety endpoint for both arms was the proportion of subjects who had no Major Adverse Event (MAE) within 30 days of
the index procedure, where the Bifurcated IDE arm was compared to the dataset of Talent AAA pivotal study (also referred as Talent
control group) and the AUI arm was compared to a performance goal (PG).
The primary effectiveness endpoint analysis for both arms was a composite defined as the proportion of subjects who have a
successful aneurysm treatment as evaluated at the time of the initial index procedure and at 12 months. The successful aneurysm
treatment endpoint included successful delivery and deployment of the stent graft, and freedom from: aneurysm diameter increase,
type I & III endoleaks, aneurysm rupture through 12 months post-implant, stent graft occlusion, conversion to surgery, and migration.
Follow up evaluations were conducted at 1 month, 6 months, 12 months, and annually thereafter for a total of 5 years from the index
procedure. The 1-year clinical data for the Bifurcated IDE arm is provided in Section 6.1.1 and for AUI arm in Section 6.1.2.
Subsequent annual follow-up through 5 years post index procedure for both Bifurcated IDE arm and AUI arm is presented in
Section 6.2 as part of the ENGAGE PAS cohort.
6.1.1 Bifurcated IDE arm
For the Bifurcated IDE arm, the mean subject age was 73.1 years and 40.7% (61/150) of subjects were above age 75. The mean age
and sex/gender distribution were similar between the Bifurcated IDE arm and Talent control group. Subjects were classified based on
the Society for Vascular Surgery (SVS) score. 29.3% of subjects were classified as SVS 3, 54.7% as SVS 2, 16.0% as SVS 1, and 0%
as SVS 0 for the Bifurcated IDE arm. The baseline SVS risk classifications were similar between the Bifurcated IDE arm and Talent
control group, with over 80% of subjects with SVS 2 or above in both study groups. In addition, the baseline medical histories were also
similar with high prevalence of hypertension, chronic obstructive pulmonary disease, and tobacco use in the past 10 years in both
study groups.
Baseline aneurysm and anatomical measurements were similar between the study groups. On average, the maximum aneurysm
diameter was 55.9 mm for Bifurcated IDE arm and 55.0 mm for the Talent control group; mean measurement of proximal neck diameter
was 23.5 mm for Bifurcated IDE arm and 25.3 mm for Talent control group; the mean diameter of right and left iliac neck were 14.2 mm
and 13.9 mm for Bifurcated IDE arm and 14.5 mm and 14.3 mm for Talent control group; proximal neck length was 31.0 mm for
Bifurcated IDE arm and 22.9 mm for Talent control group; infra-renal neck angulation was 35.2° for Bifurcated IDE arm and 30.5° for
Talent control group. The primary safety endpoint is an analysis of the MAEs within 30 days. 96% of subjects in the Bifurcated IDE arm
were MAE-free as compared to 89.2% of subjects in the Talent control group as shown in Table 2 and Table 3.
16
Table 2. MAE free-rate within 30 days
MAE free rate within 30 days Bifurcated IDE arm (%m/n) Talent control group (%m/n)
MAEs free-rate within 30 days 96.0% (144/150) 89.2% (148/166)
Table 3. MAEs within 30 days
Major Adverse Event (MAE) within 30
days
a
Bifurcated IDE arm (%m/n) Talent control group (%m/n)
MAE at 30 days 4.0% (6/150) 10.8% (18/166)
All-cause death 0.0% (0/150) 1.8% (3/166)
Myocardial infarction 0.7% (1/150) 1.8% (3/166)
Renal failure 0.7% (1/150) 1.8% (3/166)
Respiratory failure 1.3% (2/150) 3.0% (5/166)
Paraplegia 0.0% (0/150) 0.0% (0/166)
Stroke 0.7% (1/150) 1.2% (2/166)
Bowel ischemia 1.3% (2/150) 0.6% (1/166)
Procedural blood loss ≥1000 cm
a
A subject may report multiple MAEs; hence, number of subjects with any MAE may not be the sum of those in each MAE category.
3
0.7% (1/150) 5.4% (9/166)
The primary effectiveness endpoint demonstrated 97.5% successful aneurysm treatment rate through 12 months for Bifurcated IDE
arm, while the Talent control group demonstrated a rate of 87.1% (Table 4). There were three (3) subjects in the Bifurcated IDE arm
that were considered treatment failures as described: During the index procedure, one subject in the Bifurcated IDE arm had the main
bifurcated body implanted but the physician was not able to cannulate the contralateral gate due to a pre-existing challenging
anatomy. The subject was ultimately converted to aorto-uni-iliac in-situ and a femoral to femoral bypass was performed. The second
subject experienced an aneurysm rupture at the index procedure. The third subject had a stent graft occlusion resulting in a femoral
to femoral bypass.
Table 4. Successful aneurysm treatment
Bifurcated IDE arm % (m/n)
Successful aneurysm treatment
a
Denominator is the number of subjects evaluable for this endpoint
b
Successful aneurysm treatment endpoint includes successful delivery and deployment, and no aneurysm growth, endoleaks, stent graft
occlusion, conversion to surgery, rupture, and migration.
b
97.5% (118/121) 87.1% (108/124)
a
Talent control group % (m/n)
a
During the index procedure, technical success was demonstrated by 99.3% successful delivery and deployment of the Endurant
bifurcated stent graft, compared to 97.6% of the Talent control group (Table 5).
Table 5. Technical success
Bifurcated IDE arm % (m/n) Talent control group % (m/n)
Technical success
a
Defined as the successful delivery and deployment of the stent graft.
a
99.3% (149/150) 97.6% (162/166)
6.1.2 AUI arm
For the AUI arm, the mean subject age was 73.8 years. 34.1% of subjects were classified as SVS 3, 50.0% as SVS 2, 15.9% as SVS
1, and 0% as SVS 0. Baseline medical histories demonstrated high prevalence of hyperlipidemia, hypertension and peripheral
vascular disease.
Baseline aneurysm and anatomical measurements included an average maximum aneurysm diameter was 52.3 mm; mean
measurement of proximal neck diameter was 22.3 mm; the mean diameter of ipsilateral and contralateral iliac diameter were both
11.5 mm; mean ipsilateral and contralateral iliac stenosis were 24.0 mm and 57.0 mm respectively; mean distal diameter of the aorta
or aneurysm above the aortic bifurcation was 22.7 mm; mean proximal neck length was 25.4 mm; mean infra-renal and suprarenal
angulations were 26.3° and 16.1° respectively. Details of the AUI arm demographic data are presented in Section 6.2.2.
The primary safety endpoint analysis demonstrated that 88.6% of subjects in the AUI arm were MAE-free within 30 days of index
procedure. Table 6 and Table 7 provide an analysis of the MAEs within 30 days.
Table 6. Freedom from Major Adverse Events within 30 days
Freedom from Major Adverse Events (MAE) within 30 days Endurant AUI % (m/n)
Freedom from MAEs within 30 days 88.6% (39/44)
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Table 7. Major Adverse Events within 30 days
Major Adverse Events (MAE) within 30 Days
a,b
Endurant AUI (% m/n)
MAEs within 30 days 11.4% (5/44)
All-cause mortality 2.3% (1/44)
Myocardial infarction 6.8% (3/44)
Renal failure 2.3% (1/44)
Respiratory failure 4.5% (2/44)
Paraplegia 0.0% (0/44)
Stroke 2.3% (1/44)
Bowel ischemia 0.0% (0/44)
Procedural blood loss ≥1000 cm
3
4.5% (2/44)
MAE w/o blood loss at 30 Days 11.4% (5/44)
a
A subject may report multiple MAEs; hence, number of subjects with any MAE may not be the sum of those in each MAE category.
b
The % MAE rate at 30 days is 100% - % Freedom from MAEs within 30 days.
The primary effectiveness endpoint was demonstrated by 99.7% successful delivery and deployment of the Endurant AUI stent graft.
Successful aneurysm treatment rate through 12 months in the Endurant AUI arm was 97.2%. One (1) subject in the AUI arm was
considered a treatment failure. This subject experienced a technical failure during the index procedure as the investigator had difficulty
recapturing the tip of the delivery system which engaged the suprarenal stents. While the investigator attempted to disengage the tip
from the suprarenal stent, the stent graft moved proximally, causing the left renal artery to be 50% obstructed by the stent graft fabric.
A left renal artery stent was placed to treat the unintentional coverage.
Table 8. Successful aneurysm treatment
Primary effectiveness endpoint Endurant AUI % (m/n)
Successful aneurysm treatment
a
Denominator is number of subjects evaluable for this endpoint.
b
Two-sided 95% confidence interval was based on a binomial distribution.
c
Successful aneurysm treatment endpoint includes successful delivery and deployment, and no aneurysm growth, endoleaks, stent graft
occlusion, conversion to surgery, rupture and migration.
c
97.2% (35/36) [ 85.5%, 99.9%]
a
95% Confidence interval
b
6.2 ENGAGE PAS cohort
The ENGAGE PAS was a multicenter, post-market, non-controlled, non-randomized, two-arm, prospective post-approval study
evaluating the long-term safety and effectiveness of the Endurant stent graft system. ENGAGE PAS cohort includes All Bifurcated
subjects arm and the AUI arm. The All Bifurcated subjects arm has a total of 328 subjects, of which 150 subjects were previously
enrolled in the Endurant US IDE study (Bifurcated IDE arm; refer Section 6.1.1 above) and 178 subjects were prospectively enrolled
as De Novo subjects in 24 participant sites in the US. The AUI arm consisted of 44 AUI subjects which were previously enrolled as a
separate arm of the Endurant US IDE study (refer Section 6.1.2 above). Clinical data was collected preoperatively to establish
eligibility at baseline, during implantation of the Endurant stent graft system, throughout the hospital stay, and postoperatively at 1
month, 12 months, and annually thereafter for a total of 5 years. In cases where follow-up data was not available for a specific visit,
subsequent follow-up data was used, e.g., when there is evidence of stent graft patency, endoleak, or freedom from migration at
12-months post index procedure. The clinical ethics committee (CEC) reviewed and adjudicated any data point pertaining to stent
graft occlusions, device migrations, type I and III endoleaks, and aneurysm sac enlargement that require further clarification. Events
were reviewed by CEC members and adjudicated as being device related, procedure related, and/or aneurysm related. ENGAGE
PAS primary endpoint was freedom from Aneurysm-Related Mortality Rate (ARM) at 5 years (1826 days), where ARM was defined
as death from rupture of the abdominal aortic aneurysm (AAA) or from any procedure intended to treat the AAA. For All Bifurcated
subjects, this primary endpoint was analyzed by comparing freedom from ARM rate observed in the study to a pre-defined
performance goal (PG) of 92%. For the AUI arm, this primary endpoint was analyzed descriptively by calculating the Kaplan Meir (KM)
estimate of 5-year freedom from ARM along with a 2-sided 95% confidence interval. In addition, technical success, MAE rates, and
other additional measures were collected at specific time intervals for both All Bifurcated subjects and AUI arm.
6.2.1 ENGAGE PAS - All bifurcated subjects
6.2.1.1 Subject accountability and follow-up
For All Bifurcated subjects (Bifurcated IDE arm + De Novo arm), 211 subjects of the total 328 subjects were eligible for 5-year
follow-up, of which 194 (92%) completed clinical followup within the visit window and 174 (82%) completed imaging follow-up.
Detailed subject accountability and follow-up are presented in Table 9.
18
Table 9. Subject and imaging accountabilitya – All Bifurcated subjects
Subjects
with imaging
Interval
(analysis
window)
Originally
performed
(site repor-
Subject follow-up
Clini-
Imagcal
fol-
Eligi-
ble
low-
up
ing
fol-
low-
up
b
CT
imag-
ing
ted)
KUB
imag-
ing
328 1
Subjects with adequate
imaging to assess the
parameter (site reported) Subject events occurring before next visit
Aneu
rysm
size
incre
ase
Endo
leak
Migra
tion
enrolled
Events
after
implant
but before
a 1 month
visit
1 month
(day 1-90)
326 323
(99%)
322
(99%)
320
(98%)
276
(85%)
311
(95%)
Events
after 1
month
visit but
before a
12 month
visit
12 month
(day
312 295
(95%)
288
(92%)
285
(91%)
270
(87%)
283
(91%)
278
(89%)
(92%)
305-548)
Events
between
12-month
and
2-year
visit
2 year
(day
293 285
(97%)
263
(90%)
259
(88%)
243
(83%)
265
(90%)
266
(91%)
(88%)
549-913)
Events
between
2-year
and
3-year
visit
3 year
(day
269 236
(88%)
208
(77%)
204
(76%)
187
(70%)
217
(81%)
208
(77%)
(76%)
914-1278
)
286
257
205
c
Tech-
nical
obser
vat-
d
ion
322
(99%)
289
(93%)
271
(92%)
221
(82%)
No
impla
nt
Con-
ver-
sion
to
sur-
gery
Deat
With-
draw
al/ear
ly termina-
h
tion
0 2 0 0
0 12 2 0
0 12 6 1
0 11 13 0
Lost
to fol-
low-
up
Not
due
for
next
visit
0
0
0
0
19
Table 9. Subject and imaging accountabilitya – All Bifurcated subjects (continued)
Subjects
with imaging
Interval
(analysis
window)
Events
Subject follow-up
Clini-
Imagcal
fol-
Eligi-
ble
low-
up
ing
fol-
low-
up
performed
(site repor-
CT
imag-
b
ing
ted)
KUB
imag-
ing
Subjects with adequate
imaging to assess the
parameter (site reported) Subject events occurring before next visit
Aneu
rysm
size
incre
ase
Endo
leak
Migra
tion
c
Tech-
nical
obser
vat-
d
ion
No
impla
nt
Con-
ver-
sion
to
sur-
gery
Deat
With-
draw
al/ear
ly termina-
h
tion
Lost
to fol-
low-
up
Not
due
for
next
visit
0 16 13 1 0
between
3-year
and
4-year
visit
4 year
(day
239 215
(90%)
192
(80%)
183
(77%)
173
(72%)
198
(83%)
189
(79%)
191
(80%)
201
(84%)
1279-164
4)
Events
0 18 6 4
0
between
4-year
and
5-year
visit
5 year
(day
211 194
(92%)
174
(82%)
164
(78%)
157
(78%)
173
(82%)
166
(79%)
167
(79%)
179
(85%)
1645-200
9)
a
Data analysis sample size varies for each of the time points above and in the following figures. This variability is due to subject availability for
follow-up, as well as, quantity and quality of images available from specific time points for evaluation. For example, the number and quality of
images available for evaluation of endoleak at 1 month is different than the number and quality of images available at 12 months due to variation
in the number of image exams performed and/or the number of images with acceptable evaluation quality.
b
Imaging Follow-up count includes CT with and without contrast, MRA with and without contrast, ultrasound and x-ray imaging.
c
Category has been expanded to include x-ray as an acceptable imaging method to evaluate migration.
d
Technical observations assessed by imaging include stent graft kinking, stent graft twisting, stent graft wireform fracture, suprarenal bare stent
fracture, anchoring pin fracture, stent graft stenosis, stent graft occlusion and other technical observations.
Note: The deaths of three (3) subjects are not counted above since two (2) occurred after the subjects’ 5-year cutoff dates, and one
(1) subject death is unknown as the site was unable to determine the exact date of death due to insufficient information on the event.
6.2.1.2 Subject demographics and baseline medical history
Baseline medical history for All Bifurcated subjects included high prevalence of hyperlipidemia, hypertension, and coronary artery
disease. Table 10 through Table 14 provide the subject demographics, baseline medical history, baseline aneurysm and anatomical
measurements, and SVS classification for All Bifurcated subjects.
Table 10. Subject demographics – All Bifurcated subjects
Parameter category/statistics All Bifurcated subjects
Age (years)
All
n 328
Mean ± SD 72.3 ± 8.1
Median 72.0
Min, Max 50, 88
Male
20
Table 10. Subject demographics – All Bifurcated subjects (continued)
Parameter category/statistics All Bifurcated subjects
n 283
Mean ± SD 72.1 ± 8.1
Median 72.0
Min, Max 50, 87
Female
n 45
Mean ± SD 73.6 ± 8.0
Median 73.0
Min, Max 58, 88
Gender % (m/n)
Male 86.3% (283/328)
Race % (m/n)
White/Caucasian 96.6% (317/328)
Black, non-Hispanic 2.1% (7/328)
Hispanic/Mexican 0.0% (0/328)
Asian/Pacific Islander 0.9% (3/328)
Native American 0.0% (0/328)
Other/Unknown 0.3% (1/328)
Table 11. Baseline medical history - All Bifurcated subjects
All Bifurcated subjects %
Body System / Condition
(m/n)
a
Cardiac
Angina 16.3% (53/326)
Arrhythmia 33.6% (110/327)
Congestive heart failure 12.5% (41/328)
Coronary artery bypass graft 28.4% (93/328)
Coronary artery disease 54.3% (178/328)
Myocardial infarction 30.2% (98/325)
Percutaneous transluminal coronary angioplasty 23.8% (78/328)
Valvular heart disease (VHD) 9.8% (32/328)
Other cardiac 15.2% (50/328)
Pulmonary
Chronic obstructive pulmonary disease 35.2% (115/327)
Renal
Abnormal renal function 19.5% (64/328)
Renal insufficiency 11.6% (38/328)
Cerebrovascular/Neurological
Cerebral vascular accident 8.8% (29/328)
Paraparesis 0.9% (3/328)
Paraplegia 0.0% (0/328)
Transient ischemic attack (TIA) 5.2% (17/327)
Other Cerebrovascular/Neurological 9.8% (32/328)
Vascular
Abdominal aortic aneurysm 3.0% (10/328)
Any thoracic aneurysm 1.5% (5/328)
Peripheral vascular disease 24.7% (81/328)
Thromboembolic event 3.4% (11/328)
Other vascular 11.0% (36/328)
Other conditions
21
Table 11. Baseline medical history - All Bifurcated subjects (continued)
All Bifurcated subjects %
Body System / Condition
(m/n)
a
Alcoholism 4.0% (13/328)
Bleeding disorder 0.9% (3/328)
Cancer 26.2% (86/328)
Carotid artery disease 19.6% (64/326)
Diabetes 22.9% (75/327)
Family history of aneurysm 15.9% (52/327)
GI complications 46.0% (151/328)
Hyperlipidemia 85.3% (278/326)
Hypertension 83.8% (275/328)
Liver disease 3.4% (11/328)
Tobacco use in the last 10 years 49.2% (161/327)
b
Other
a
Denominator reflects the number of subjects that selected “yes” or “no” to the corresponding condition. Subjects that selected “unknown” for
certain categories were not counted in the denominator.
b
”Other” was captured only for the Endurant IDE arm. As a result of this, the denominator reflects the total number of subjects enrolled in the
Endurant IDE arm.
87.3% (131/150)
Table 12. Baseline aneurysm and anatomical characteristics (site reported) – All Bifurcated subjects
Dimension All Bifurcated subjects
Maximum aneurysm
diameter (mm)
a
n
328
Mean ± SD 56.6 ± 8.2
Median 54.0
Min, Max 42, 98
Proximal neck diameter
(mm)
a
n
328
Mean ± SD 23.8 ± 3.2
Median 23.0
Min, Max 19, 40
Right iliac diameter
2
(mm)
a
n
327
Mean ± SD 14.1 ± 3.6
Median 13.0
Min, Max 8, 25
Left iliac diameter (mm)
2
a
n
328
Mean ± SD 13.8 ± 3.4
Median 13.0
Min, Max 8, 25
Proximal neck length
(mm)
a
n
328
Mean ± SD 27.0 ± 12.7
Median 24.0
Min, Max 5, 76
Infrarenal neck angle (°)
a
n
328
Mean ± SD 24.6 ± 15.8
Median 25.0
22
Table 12. Baseline aneurysm and anatomical characteristics (site reported) – All Bifurcated subjects (continued)
Dimension All Bifurcated subjects
Min, Max 0, 60
Suprarenal neck angle (°)
a
n
327
Mean ± SD 14.1 ± 11.5
Median 10.0
Min, Max 0, 60
a
n = number of subjects with readable scans.
Note: It was noted that four (4) subjects had baseline anatomical characteristics outside the Endurant stent graft system Instructions
for Use. The measurements were entered into the database by investigational sites after the subjects were enrolled into the study.
Medtronic had taken steps to ensure that the investigational sites enrolled and treated subjects following the guidelines of the
Instructions for Use for the Endurant stent graft system. Medtronic conducted retraining to the sites on the Instructions for Use, and
investigational sites were notified of these protocol deviations and they reported them to their IRBs.
Table 13. Baseline maximum aneurysm diameter (site reported) – All Bifurcated subjects
Statistics/category All Bifurcated subjects
Maximum aneurysm
diameter % (m/n)
a
< 40 mm 0.0% (0/328)
40 mm - < 50 mm 5.5% (18/328)
50 mm - < 60 mm 72.9% (239/328)
60 mm - < 70 mm 13.4% (44/328)
70 mm - < 80 mm 5.5% (18/328)
80 mm - < 90 mm 1.8% (6/328)
90 mm - < 100 mm 0.9% (3/328)
≥ 100 mm 0.0% (0/328)
a
n = number of subjects with readable scans.
Table 14. SVS classification – All Bifurcated subjects
SVS classification All Bifurcated subjects % (m/n)
SVS 0 0.3% (1/328)
SVS 1 18.3% (60/328)
SVS 2 51.8% (170/328)
SVS 3 29.6% (97/328)
6.2.1.3 Devices implanted
Table 15 provides the number of Endurant stent graft devices implanted (which includes the bifurcated stent graft as well as aortic and
iliac extensions) at the index procedure per subject. Table 16 shows the distribution of sizes of the bifurcated stent graft used and
Table 17 provide the devices implanted by type.
Table 15. Total number of devices implanted at index procedure – All Bifurcated subjects
Number of devices implanted All Bifurcated subjects % (m/n)
a
1 0.3% (1/327)
2 38.8% (127/327)
3 32.7% (107/327)
4 25.7% (84/327)
5 2.1% (7/327)
6 0.3% (1/327)
≥ 7 0.0% (0/327)
a
Denominator includes all subjects who were implanted with at least one test device.
23
Table 16. Devices implanted by size at index procedure – All Bifurcated subjects
Stent graft proximal diameter (main bifurcated, mm) All Bifurcated subjects % (m/n)
a
23 8.87% (29/327)
25 24.46% (80/327)
28 35.17% (115/327)
32 21.10% (69/327)
36 10.40% (34/327)
a
Denominator includes all subjects who received the main bifurcated test device.
Table 17. Devices implanted by type - All Bifurcated subjects
Device type All Bifurcated subjects % (m/n)
a
Main bifurcated 100.0% (327/327)
Contralateral limb 99.7% (326/327)
Extension - any type 31.2% (102/327)
Extension - iliac 28.4% (93/327)
Extension - aorta 3.1% (10/327)
a
Denominator includes all subjects who received the test device. A subject may receive multiple device types
6.2.1.4 Acute procedural data
Acute procedural data for All Bifurcated subjects is summarized in Table 18. The median procedure duration was 83 minutes and
84.8% (278/328) of the subjects received general anesthesia. The median blood loss reported for all subjects was 150 cm3.
Table 18. Acute procedural data – All Bifurcated subjects
Acute procedural data All Bifurcated subjects
Duration of procedure (min)
n 328
Mean ± SD 93.5 ± 45.2
Median 83.0
Min, Max 26, 318
Subjects receiving general anesthesia 84.8% (278/328)
Estimated blood loss (cm3)
n 327
Mean ± SD 170.4 ± 146.6
Median 150.0
Min, Max 0, 1450
Subjects requiring blood transfusion 1.2% (4/328)
Time in ICU (hour)
n 328
Mean ± SD 8.9 ± 24.0
Median 0.0
Min, Max 0, 216
Overall hospital stay (day)
n 328
Mean ± SD 2.2 ± 2.4
Median 1.0
Min, Max 1, 22
Note: Only available data were included in the calculation.
6.2.1.5 Technical success
During the index procedure, 99.1% of All Bifurcated subjects were recorded as having successful delivery and deployment of the
Endurant bifurcated stent graft as shown in Table 19. One (1) subject in the Bifurcated IDE arm and two (2) subjects in the De Novo
arm experienced a technical failure at the time of implant. The IDE subject experienced a deployment failure as there was difficulty
cannulating the gate due to challenging anatomy. There were no device malfunctions associated with the technical failure. This
subject was followed until expiration on day 721 post implant; the death was adjudicated as not related to the aneurysm, device, or
procedure. One (1) De Novo subject experienced unintentional coverage of both renal arteries that resulted in a right renal artery
24
occlusion. This was treated with renal stenting and blood flow was restored to the right renal artery. Blood flow was restored to the left
renal artery using a pull-down technique to the stent graft. This subject has reported no additional clinical sequelae. The other De Novo
subject did not receive an Endurant device due to unsuitable anatomy at the time of the index procedure and was enrolled as intent
to treat (ITT) subject based on the protocol definition of enrollment.
Table 19. Technical success – All Bifurcated Subjects
Outcome All Bifurcated subjects % (m/n)
Technical success
a
Technical success of the Endurant stent graft system (assessed intra operatively) is successful delivery and deployment of the Endurant stent graft
system in the planned location and with no unintentional coverage of both internal iliac arteries or any visceral aortic branches and with the removal
of the delivery system.
a
99.1% (325/328)
6.2.1.6 Aneurysm-Related Mortality (ARM)
ARM is defined as a death of any cause within 30 days of the initial procedure or a death adjudicated as caused by an aneurysm
rupture. Additionally, if a death occurred within 30 days of any procedure intended to treat the AAA, then it is presumed to be aneurysm
related unless there is evidence to the contrary. For All Bifurcated subjects, the overall freedom from ARM at 5 years was 99.0% and
is presented in the Kaplan-Meier estimates in Table 20 and Figure 4.
There have been three (3) reports of ARM. One (1) De Novo subject died 4 days post-procedure due to a GI bleed. The other De Novo
subject died 6 days post-procedure due to cardiopulmonary failure. One (1) IDE subject died between 1097-1461 days
post-procedure due to aneurysm expansion due to a Type I endoleak. All three (3) deaths were adjudicated as aneurysm-related by
the CEC. The lower bound of 1-sided 95% confidence limit (98%) is higher than the Performance Goal of 92%. As a result, at a
one-sided significance level of 0.05, the pre-specified Performance Goal was met.
Table 20. Kaplan-Meier estimates for Freedom from Aneurysm-Related Mortality – All Bifurcated subjects
No. at risk
732-1096
0-30 days 31-365 days 366-731 days
a
328 326 310 292 267 234
days
1097-1461
days
1462-1826
days
No. of events 2 0 0 0 1 0
No. censored
Kaplan-Meier estimate
Standard error
b
c
c
0 16 18 25 32 73
0.994 0.994 0.994 0.994 0.990 0.990
0.004 0.004 0.004 0.004 0.006 0.006
95% CI lower limit 0.985 0.985 0.985 0.985 0.979 0.979
95% CI upper limit 1.000 1.000 1.000 1.000 1.000 1.000
a
Number of subjects at risk at the beginning of the interval.
b
Subjects are censored because their last follow-up has not reached the end of the time interval or because they withdraw, are lost to follow-up or
die from non aneurysm-related death.
c
Estimate along with its standard error using Greenwood method were made at end of time interval.
25
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