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2011/DEC/22 at 7:46 p.m. Doc number: M716803B001 [multi23]
Endurant
Stent Graft System
1.
Device Description .................................................................................. 8
2.
Indications for Use ................................................................................ 11
3.
Contraindications .................................................................................. 11
4.
Warnings and Precautions .................................................................... 11
5.
Adverse Events ..................................................................................... 12
6.
Patient Selection and Treatment ........................................................... 13
7.
Patient Counseling Information ............................................................. 13
8.
How Supplied ........................................................................................ 14
9.
Clinician Use Information ...................................................................... 14
Important!
•
Do not attempt to use the Endurant Stent Graft System before completely reading and
understanding the information contained in this booklet.
•
Carefully inspect all product packaging for damage or defects prior to use. Do not use
product if any sign of damage or breach of the sterile barrier is observed.
•
These devices are supplied STERILE for single use only. After use, dispose of the
delivery catheters in accordance with hospital, administrative, and/or government policy.
Do not resterilize.
1. Device Description
The Endurant Stent Graft System is designed to treat infrarenal abdominal aortic or aorto-iliac aneurysms
using an endovascular approach. When placed within the aneurysm, the Endurant Stent Graft provides a
permanent, alternative conduit for blood flow within the patient's vasculature by excluding the aneurysmal
sac from blood flow and pressure.
The Endurant Stent Graft System is comprised of two key components: the Endurant Stent Graft and the
Endurant Delivery System. An Endurant Stent Graft is the final in situ configuration of one or more
physician selected modular Endurant stent graft components. Some stent graft components include a
suprarenal stent with anchoring pins. The Endurant Delivery System delivers the Endurant Stent Graft.
Each stent graft component is compressed and held constrained by the delivery system as it is advanced
to the aneurysm location over a guidewire. As deployment occurs, the stent graft components including
the suprarenal stents and anchor pins self-expand due to the superelastic properties of the nitinol stents.
Upon deployment, the proximal and distal ends of the Endurant Stent Graft conform to the shape and size
of the proximal and distal seal zones due to the radial force of the stents.
1.1. Stent Graft Components
The particular configuration of an Endurant Stent Graft (Figure 1) is assembled by selecting from a number
of modular stent graft components including in one configuration a bifurcated modular device comprised
of two primary components: an aortic-iliac bifurcated component and a contralateral limb component.
Additional components which may be used at the discretion of the treating physician include aortic
extensions, abdominal tubes, iliac extensions, and aorto-uni-iliac (AUI) stent grafts. After the placement
of the bifurcated component, each subsequent component is introduced separately into the vasculature
and is mated in vivo to the components already in situ.
All components are composed of metal stents coupled to a fabric graft. The suprarenal stents with
anchoring pins adjacent to the crowns are initially formed by laser cutting nitinol tubing. The bifurcated
body component includes seal, body, contour, and limb stents formed of nitinol wire. The wire stents are
each formed in a ring with opposing ends being joined together in a crimp sleeve. The suprarenal stents
are sewn to the multifilament polyester (PET) graft fabric using ultra high molecular weight polyethylene
(UHMWPE) suture. The wire formed stents are sewn to the graft fabric using polyester suture.
Radiopaque markers are sewn onto each component of the stent graft to aid in visualization and to facilitate
accurate placement of each component. Radiopaque markers are located at the proximal and distal ends
of the graft material of each stent graft component, as well as at the location of the bifurcation and
contralateral gate of the bifurcated stent graft component to help visualize the edges and locations of the
stent grafts. The nitinol stents may also be visualized under fluoroscopy.
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Figure 1. Endurant Stent Graft Configurations (Bifurcated, Contralateral Limb, Aortic Extension,
3. Radiopaque Gate Marker
4. Radiopaque Overlap Marker
5. Aortic Extension / Abdominal Tube
Note: Graphic representation not to scale
8
English
20071610
printspec:a6
Instructions for Use
TABLE OF CONTENTS
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lliac Extension, and AUI)
6. Bifurcated
7. Iliac Extension
8. Contralateral Limb
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