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Merit
WRAPSODY
Endoprosthesis
DESCRIPTION
The Merit WRAPSODY™ Endoprosthesis is comprised of the WRAPSODY Endoprosthesis
and the WRAPSODY Delivery Catheter System. The WRAPSODY Endoprosthesis is a flexible,
self-expanding endoprosthesis designed for placement in the vasculature. The WRAPSODY
Endoprosthesis is made of nitinol that is encapsulated between layers of fluoropolymer.
Placement of the WRAPSODY Endoprosthesis is facilitated by radiopaque markers, three on each
end, that are located on both end rows of the WRAPSODY Endoprosthesis (see Figure 1). Both
ends of the WRAPSODY Endoprosthesis are trimmed in a scalloped manner.
The WRAPSODY Endoprosthesis is compressed and preloaded onto the WRAPSODY Delivery
Catheter System and is housed in the endoprosthesis Pod (Figure 2). The WRAPSODY Delivery
Catheter System is designed for single-handed deployment and consists of a deployment
handle (see Figure 2) that allows for controlled delivery of the WRAPSODY Endoprosthesis. The
working length (see Figure 2) of the WRAPSODY Delivery Catheter has a hydrophilic coating. The
WRAPSODY Delivery Catheter System has one port with a female luer connection for flushing
both the guide wire lumen and the endoprosthesis Pod. The WRAPSODY Delivery Catheter
shaft has radiopaque marker bands, corresponding to the proximal and distal ends of the
endoprosthesis Pod, to provide guidance during placement of the WRAPSODY Endoprosthesis.
HOW SUPPLIED
The Merit WRAPSODY Endoprosthesis System is supplied STERILE. Sterilization is done with
ethylene oxide.
INDICATIONS FOR USE
The Merit WRAPSODY Endoprosthesis System is a flexible self-expanding endoprosthesis
indicated for use in hemodialysis patients for the treatment of stenosis or occlusion within the
dialysis outflow circuit of an arteriovenous (AV) fistula or AV graft.
CONTRAINDICATIONS
•
Do not use if full expansion of a PTA balloon cannot be achieved during pre-dilation.
•
Do not use in patients who have a hypersensitivity to nickel.
WARNINGS
•
This device is intended for use by physicians who are familiar with the complications, side
effects, and dangers associated with intravascular endoprosthesis procedures.
•
Keep dry. Protect the packaged product from direct exposure to sunlight.
•
The sterile packaging and devices should be inspected prior to use. Verify that the
packaging and the devices are undamaged and that the sterile barrier is intact. If damaged,
do not use.
•
Do not use the WRAPSODY device after the expiration date.
•
Care should be used to avoid puncturing or cutting the WRAPSODY Endoprosthesis.
•
Do not use a kinked WRAPSODY Delivery Catheter or kinked valved introducer sheath as
this may result in difficulty or inability to deploy the WRAPSODY Endoprosthesis.
•
An appropriately stiff guide wire is required to be in place before introduction of the
WRAPSODY Delivery Catheter into the body. The guide wire must remain in place during
™
I N S T R U C T I O N S F O R U S E
Scalloped End Rows
PTFE/ePTFE
Radiopaque Markers
Deployment
Handle
Safety Clip
(Remove Before
Deploying Endoprosthesis)
Port for Flushing and
Guide Wire Insertion
Figure 1.
Nitinol Wires
Figure 2.
Hydrophilic Working Length
Marker Bands
Endoprosthesis Pod
24.4 cm
Extreme End
Distal Tip
Radiopaque
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