Medtronic Endurant Manual Del Usuario página 12

2011/DEC/22 at 7:46 p.m. Doc number: M716803B001 [multi23]
The Talent Occluder Delivery System consists of a dilator used for delivery system insertion, a cartridge
preloaded with the Talent Occluder, a sheath for delivering the stent graft to the target location, and a
pushrod to advance and help deploy the stent graft. Additional details are available in the Talent Abdominal
Stent Graft System Instructions for Use.
1.3. Endurant Delivery System
The Endurant Stent Graft is delivered by the Endurant Delivery System, which facilitates the placement
of the various selected stent graft components via the arterial vasculature (e.g., femoral arteries). Using
fluoroscopic guidance, the Endurant Delivery System is properly positioned within the patient's vasculature
and a specific stent graft component is deployed.
The Endurant Delivery System is a general title for two specific types of Endurant Delivery Systems: (1)
Endurant Aortic Delivery System and (2) Endurant Iliac Delivery System. Each consists of a single use,
disposable catheter with an integrated handle to provide the user with accurate and controlled deployment.
The catheter assembly is flexible and compatible with a 0.035" (0.89 mm) guidewire. The Endurant Aortic
Delivery System is for delivering Endurant bifurcated, aortic extension/abdominal tube and aorto-uni-iliac
(AUI) stent graft components. The Endurant Iliac Delivery System is for delivering the Endurant
contralateral limb and iliac extension stent graft components.
1.3.1. Endurant Aortic Delivery System
The Endurant Aortic Delivery System (Figure 4 – Figure 6) is constructed of four concentric single lumen
shafts (an outer hydrophilic coated polymer graft cover, a stainless steel spindle-tube shaft, a middle
member polymer shaft, and a guidewire lumen containing nitinol inner member). A stent stop is attached
to the distal end of the middle member shaft.
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Figure 4. Endurant Aortic Delivery System
1. Back-end wheel
2. Back-end screw gear
3. Screw gear
4. Front grip
Note: Graphic representation not to scale
See Figure 5 for the taper tip detail of the Endurant Aortic Delivery System. An atraumatic tapered
polymeric tip is attached at the distal end of the inner member to facilitate tracking through tortuous and
calcified vessels. A metallic spindle is attached to the distal end of the spindle-tube shaft to prevent axial
movement of the suprarenal stent crowns before release. Attached to the proximal end of the polymeric
tip is a metallic sleeve that holds the suprarenal stent crowns and anchor pins constrained and on the
spindle. The polymeric taper tip, stent stop, and ring marker on the distal end of the graft cover are
radiopaque and aid in fluoroscopic visualization. Retraction of the graft cover while the suprarenal stent
crowns are held by the spindle and the metallic sleeve of the tapered tip is designed to allow for accurate
positioning and partial deployment of the body of the bifurcated stent graft component.
Figure 5. Endurant Aortic Delivery System – Taper Tip Detail
1. Taper Tip
2. Suprarenal Stent
3. Spindle
4. Markerband
5. Sleeve
6. Graft Cover
Note: Graphic representation not to scale
The back-end wheel can be rotated clockwise to advance the inner member attached to the taper tip,
thereby moving the metallic sleeve forward to release the suprarenal stent crowns and adjacent anchor
pins from the spindle. After release of the suprarenal stent crowns, the back-end wheel should be rotated
counter clockwise to reseat the tip of the delivery system before performing the step of retracting the taper
tip to the graft cover through the deployed stent graft component in the process of removing the delivery
system from the body.
Figure 6. Endurant Aortic Delivery System – Back End Detail
1. Rear Handle
2. Back-End Wheel
3. Back-End Screw Gear
Note: Graphic representation not to scale
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5. Tip capture
6. Rear handle
7. External slider
8. Graft cover
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