Medtronic Endurant Manual Del Usuario página 11

2011/DEC/22 at 7:46 p.m. Doc number: M716803B001 [multi23]
1.1.1. Bifurcated Stent Graft Component
The proximal section of the bifurcated stent graft component in use is deployed into the proximal neck and
upper section of the aneurysm. All stents on the proximal aortic section of the bifurcated component are
sewn to the outside of the graft fabric. The proximal stent (suprarenal) of the aortic section is not covered
with graft fabric. As such, this bare stent design allows the Endurant Stent Graft to be fixed above the renal
arteries without obstructing them with graft fabric. Refer to Figure 2 for a pictorial representation of the
proximal configuration. The suprarenal stent has anchoring pins to help fix the stent graft in place. The
suprarenal stent is joined to the proximal edge of the graft by ultra high molecular weight polyethylene
suture.
Figure 2. Endurant Bifurcated Stent Graft Component Aortic Proximal Configuration
Note: Graphic representation not to scale
Distally, the aortic section bifurcates into two smaller tubes: an ipsilateral single iliac limb and a
contralateral (stub) leg. In the ipsilateral limb of the bifurcated stent graft component, the stents are sewn
to the outside of the graft fabric providing a smooth inner lumen. In the contralateral stub leg of the
bifurcated stent graft component, the stents are sewn to the inside of the graft fabric providing additional
friction for higher disjunction (separation) forces with the contralateral limb component. Refer
to Figure 3 for a pictorial representation of the ipsilateral limb distal configuration of the Endurant Bifurcated
Stent Graft Component.
Figure 3. Endurant Bifurcated Stent Graft Limb Distal Configuration
Note: Graphic representation not to scale
The diameters of the available proximal aortic section of the bifurcated stent graft components range from
23 mm to 36 mm, and the covered length of the bifurcated stent graft components range from 120 mm to
170 mm. In use, all stent graft components are oversized to fix the stent graft components in place and to
provide sealing for the exclusion of the aneurysm. The aortic sections of the bifurcated stent graft
components should be oversized approximately 10% to 20% in relation to the actual measured vessel
inner diameter. The available aortic sections sizes are able to be used in aortas with diameters ranging
from 19 mm to 32 mm. The dimensions of the ipsilateral distal limb portion of the bifurcated stent graft
components range in diameter from 13 mm to 20 mm, which can be used in iliac arteries with diameters
ranging from 10 mm to 18 mm. If a larger range of limb sizes is necessary, refer to Section 1.1.3.
1.1.2. Contralateral Limb Component
The proximal end of the tube-like contralateral limb component is deployed within the contralateral stub
leg of the bifurcated stent graft component, while the contralateral limb component's distal end is deployed
in the contralateral iliac artery. The proximal section of the contralateral limb component uses an open
web configuration. The intent of the design is to reduce the risks of endoleaks. The distal diameter of
contralateral limb components available range from 10 mm to 28 mm with total lengths ranging from 80 mm
to 120 mm. The contralateral limb component should be oversized approximately 10% to 25% in relation
to the vessel inner diameter and can be used in iliac arteries ranging from 8 mm to 25 mm.
1.1.3. Iliac Extension Component
In cases in which additional distal length of the stent graft is needed, iliac extension components are
available. The iliac extension component has a proximal end open web configuration similar to
contralateral limb component. The diameters of available iliac extension components range from 10 mm
to 28 mm with a covered length of 80 mm. Similar to the contralateral limb component, the iliac extension
component is designed for oversizing of 10% to 25% and can be used in iliac arteries ranging from 8 mm
to 25 mm in diameter.
1.1.4. Aortic Extension Component
In cases in which additional proximal length of the stent graft is needed, aortic extension components are
available. The aortic extension components use the same proximal bare suprarenal stent with anchoring
pin design as the proximal stent of the aortic section of the bifurcated component. The diameters of
available aortic extension components range from 23 mm to 36 mm with the aortic extension having a
covered length of 45 mm. Similar to the bifurcated component, the aortic extension component is designed
for oversizing of 10% to 20% and can be used in aortic arteries ranging from 19 mm to 32 mm in diameter.
1.1.5. Abdominal Tube Component
In cases in which additional proximal length of the stent graft longer than provided by the Aortic Extension
Component is needed, abdominal tube components are available. They are identical to the Aortic
Extension Component except that they have a covered length of 70 mm.
1.1.6. Aorto-Uni-Iliac (AUI) Stent Graft Component
The proximal section of the aorto-uni-iliac stent graft component in use is deployed into the proximal neck
and upper section of the aneurysm. All stents on the proximal aortic section of the aorto-uni-iliac
component are sewn to the outside of the graft fabric. The proximal stent (suprarenal) of the aortic section
is not covered with graft fabric. As such, this bare stent design allows the aorto-uni-iliac stent graft
component to be fixed above the renal arteries without obstructing them with graft fabric. Refer
to Figure 2 for a pictorial representation of the proximal configuration. The suprarenal stent includes
anchoring pins to help fix the AUI stent graft component in place. The suprarenal stent is joined to the
proximal edge of the graft by ultra high molecular weight polyethylene suture.
Distally, the proximal aortic section tapers down to a smaller diameter tube. In the distal end of the tapered
aorto-uni-iliac component, the stents are sewn to the inside of the graft fabric.
The diameters of the available proximal aortic section of the aorto-uni-iliac stent graft components range
from 23 mm to 36 mm, and the covered length of the aorto-uni-iliac stent graft component is 105 mm. In
use, all stent graft components are oversized to fix the stent graft components in place and to provide
sealing for the exclusion of the aneurysm. The aortic sections of the aorto-uni-iliac stent graft components
should be oversized approximately 10% to 20% in relation to the actual measured vessel inner diameter.
The available aortic sections sizes are able to be used in aortas with diameters ranging from 19 mm to
32 mm. The diameter of the distal end of the aorto-uni-iliac stent graft component is 14 mm.
1.2. Talent Occluder System
The Talent Occluder System is available to be used with Endurant Stent Graft System. The Talent
Occluder System is typically used in conjunction with the aorto-uni-iliac component and a femoral-femoral
bypass in the event that:
•
It is not possible to place a bifurcated component due to patient's anatomy, tortuous anatomy, a
significant extension of aneurysmal disease, inability to access the contralateral iliac.
•
It is needed to stop retrograde blood flow into the aneurysm sac.
•
It is needed for repair.
The Talent Occluder System is a tubular stent graft segment sealed at both ends. The Talent Occluder
System ensures that the blood flowing through the contralateral iliac artery does not "backflow" into the
aneurysm sac, but instead flows from the femoral-femoral bypass into the patient's contralateral leg artery.
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