Intended Use / Indications; Contraindications - GORE VIABAHN Gebrauchsanweisung

INSTRUCTIONS FOR USE FOR
GORE® VIABAHN® Endoprosthesis
Carefully read all instructions prior to use. Observe all warnings and precautions noted throughout these instructions. Failure
to do so may result in complications.
DESCRIPTION
The GORE® VIABAHN® Endoprosthesis is a flexible, self-expanding endoluminal endoprosthesis consisting of an expanded
polytetrafluoroethylene (ePTFE) lining with an external nitinol (NiTi = Nickel:Titanium) support extending along its entire length
(Figure 1). 5-8 mm devices have four radiopaque markers on each end of the endoprosthesis to facilitate accurate placement and improve
visibility of the device post-deployment. The endoprosthesis is compressed and attached to a dual lumen delivery catheter (Figure 2). The
larger central catheter lumen is used for flushing and guidewire introduction. The smaller lumen contains elements of the deployment
mechanism. The delivery catheter hub assembly has one port for the deployment system and one port for flushing and guidewire
insertion. To facilitate accurate endoprosthesis placement, two radiopaque metallic bands are attached to the catheter shaft, marking the
ends of the compressed endoprosthesis.
The GORE® VIABAHN® Endoprosthesis is supplied STERILE.
The GORE® VIABAHN® Endoprosthesis should not be resterilized.
FIGURE 1A: GORE® VIABAHN® ENDOPROSTHESIS 5-8 MM DEVICES
External Nitinol Stent
Radiopaque
Markers
FIGURE 1B: GORE® VIABAHN® ENDOPROSTHESIS 9-13 MM DEVICES
External Nitinol Stent
ePTFE Lining
FIGURE 2A: GORE® VIABAHN® ENDOPROSTHESIS DELIVERY SYSTEM 5-8 MM DEVICES
Deployment
Knob
Hub Assembly
Guidewire / Flushing Port
FIGURE 2B: GORE® VIABAHN® ENDOPROSTHESIS DELIVERY SYSTEM 9-13 MM DEVICES
Deployment
Knob
Hub Assembly
Guidewire / Flushing Port

INTENDED USE / INDICATIONS

The GORE® VIABAHN® Endoprosthesis is a flexible, self-expanding endoluminal prosthesis for endovascular grafting of peripheral arteries.
The GORE® VIABAHN® Endoprosthesis is also indicated for improving blood flow in symptomatic obstructions of peripheral veins.

CONTRAINDICATIONS

• Non-compliant lesions where full expansion of an angioplasty balloon catheter was not achieved during pre-dilatation, or where lesions
cannot be dilated sufficiently to allow passage of the delivery system.
Radiopaque
Markers
ePTFE Lining
Catheter
Shaft
Catheter
Shaft
1
Endoprosthesis
Radiopaque
Markers
Constrained
Endoprosthesis
Catheter
Radiopaque
Markers
Constrained
Endoprosthesis
Catheter
Radiopaque
Markers