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•
Using fluoroscopic guidance, advance the WRAPSODY Delivery Catheter. Advance
cautiously, especially if resistance is felt. If excessive resistance is felt, reassess procedure.
•
Continue to advance delivery system until the leading edge of the endoprosthesis is past
the lesion. Then, maintaining tip position, pull slightly to straighten the delivery system.
•
Using fluoroscopy, verify that delivery catheter is optimally positioned for deployment
and that the selected endoprosthesis length covers the entire lesion and both ends of the
endoprosthesis extend at least 1 cm into a non-diseased vessel segment.
Deploying the Merit WRAPSODY Endoprosthesis : Standard Deployment
Distal marker
band
Proximal marker
band
•
Advance the Merit WRAPSODY Endoprosthesis Delivery Catheter until the distal marker
band (see Figure 4a) is just past the desired endoprosthesis landing zone.
•
Deployment of the WRAPSODY Endoprosthesis requires a priming step prior to full
deployment of the endoprosthesis. Prime the system by performing several micro-clicks
(partial depression of the handle) until the catheter outer sheath begins to retract and the
distal marker band aligns with the WRAPSODY Endoprosthesis marker bands (see Figure
4b).
•
Confirm desired deployment location and adjust by pulling or advancing the catheter.
•
Continue performing micro-clicks of the delivery handle to further retract the outer
sheath of the delivery catheter, uncovering the leading edge of the unconstrained
WRAPSODY Endoprosthesis. A short segment of the WRAPSODY Endoprosthesis will begin
to expand or flare from the end of the catheter. Continue to deploy until the first row of the
endoprosthesis has deployed and contacts the vessel wall (see Figure 4c). At this point,
the endoprosthesis may be pulled back to the target deployment location (see Figure 4d).
Note: The WRAPSODY Delivery System should not be advanced forward once any portion
of the endoprosthesis is apposing the vessel wall.
•
Continue depressing the WRAPSODY Endoprosthesis handle, while applying light tension
to the catheter during endoprosthesis deployment until the endoprosthesis is completely
released from delivery system (see Figure 4e).
•
Note: The proximal marker band on the WRAPSODY Delivery Catheter should be
visualized and remain in stable position during deployment.
•
Once the WRAPSODY Endoprosthesis is fully deployed and no longer constrained by the
delivery catheter, carefully withdraw the delivery system under fluoroscopic imaging,
to ensure delivery catheter tip does not catch on the WRAPSODY Endoprosthesis, which
could cause endoprosthesis dislodgement. Maintain position of the guide wire through
the WRAPSODY Endoprosthesis.
•
Excessive force during delivery catheter removal may damage the delivery catheter or
the valved introducer sheath. If resistance is encountered when removing the delivery
catheter, it is recommended to remove the delivery catheter and valved introducer
sheath as a unit, maintaining guide wire position through the deployed WRAPSODY
Endoprosthesis. Then, insert a new valved introducer sheath of identical size as the one
that was removed.
•
Select an appropriately sized PTA balloon (Table 1), no greater in diameter than the
WRAPSODY Endoprosthesis, to perform post deployment dilation. Inflate the PTA balloon
along the entire length of the WRAPSODY Endoprosthesis. Multiple inflations may be
required if the WRAPSODY Endoprosthesis length is longer than the PTA balloon. Avoid
balloon dilation beyond the ends of the WRAPSODY Endoprosthesis.
•
After completion of the touch-up procedure, deflate PTA balloon and carefully remove it.
•
Use contrast angiography to evaluate the treated vessel segment and distal flow circuit
prior to completing the procedure (see Figure 4f).
Figure 4 a-f
a
b
c
d
e
f
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