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DIRECTIONS FOR USE
Initial Preparation
•
Select the appropriate vessel to access. Use the appropriate local anesthesia. A
percutaneous Seldinger technique is preferred. A cutdown may be performed when
necessary.
•
Once vascular access is gained, insert an appropriately sized, valved introducer sheath for
insertion of the WRAPSODY Delivery Catheter.
•
Prepare an appropriate guide wire per its Instructions For Use and advance the guide wire
under fluoroscopy across the lesion.
•
Prior to placement of the Merit WRAPSODY Endoprosthesis, pre-dilate the lesion with
percutaneous transluminal angioplasty (PTA) in accordance with the manufacturer's
Instructions For Use. Ensure full expansion of the balloon within the lesion.
•
Following deflation of the angioplasty balloon, evaluate the results angiographically.
Sizing and Selection of the WRAPSODY Endoprosthesis
•
Assess the vessel to determine the diameter and length of the WRAPSODY Endoprosthesis
needed. It is recommended to use the healthy vessel diameter immediately adjacent
to the lesion to determine the endoprosthesis diameter. Use Table 1 to select the most
appropriate WRAPSODY Endoprosthesis. Undersizing of the WRAPSODY Endoprosthesis
diameter may result in device migration.
•
The WRAPSODY Endoprosthesis lengths listed in Table 1 are nominal. When determining
the length of the endoprosthesis, please note that the endoprosthesis should overlap the
healthy vessel at least 1 cm beyond the proximal and distal margins of the lesion.
•
If multiple devices are to be overlapped, the recommended tips should be followed:
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The diameter of devices being overlapped should not differ by more than 2 mm.
If unequal device diameters are used, the smaller device should be placed first and
•
then the larger device should be placed inside the smaller device.
•
To ensure that all overlapped WRAPSODY Endoprosthesiss are in good apposition to
each other, it is recommended that the overlap distance be a minimum of 1 cm across
devices being used.
•
Post-dilation of the first WRAPSODY Endoprosthesis should be performed prior to
placing the second device. Then post-dilation of the second device is performed.
•
Check expiration date on product package. If product is expired, do not use. Make sure
there is no damage to the package or the sterile barrier – if there is damage or the sterile
barrier has been compromised do not use. Remove the outer pouch and place the inner
pouch (which is sterile) onto the sterile field. Carefully remove contents of the inner pouch
and inspect for damage such as kinks, bends, or other damage. If any damage is found,
do not use.
•
Prior to inserting the WRAPSODY Delivery Catheter into the valved introducer sheath,
check that the diameter and length of the endoprosthesis as well as the delivery catheter
length are correct for the lesion being treated.
Introduction and Positioning of the Merit WRAPSODY Endoprosthesis System
•
When pre-deployment PTA has been successfully completed, be sure to remove the
deflated balloon catheter while maintaining position of the guide wire beyond the target
lesion.
•
Ensure that the stiff guide wire is 0.035" (0.889 mm).
•
Before inserting the WRAPSODY Delivery Catheter into the patient, prepare the delivery
catheter. First, flush the endoprosthesis Pod. This is done by placing a finger to occlude the
distal end of the delivery catheter (see Figure 3) followed by injecting sterile heparinized
saline through the flushing port (see Figure 2). Watch for drops of saline to emerge at the
junction of the endoprosthesis Pod and the tip, as this will indicate that the endoprosthesis
Pod has been successfully flushed (see Figure 3). Second, flush the guide wire lumen.
This is done by removing the finger followed by injecting sterile heparinized saline
through the flushing port (see Figure 3). Watch for saline to emerge from the end of the
delivery catheter. Finally, wet the hydrophilic coating of the delivery catheter using sterile
heparinized saline to ensure smooth introduction through the valved introducer sheath.
•
With the WRAPSODY Delivery Catheter as straight as possible, insert the "back end" of
guide wire into the tip of the delivery catheter (see Figure 2) making sure to maintain
guide wire position. Carefully advance the WRAPSODY Delivery Catheter through the
valved introducer sheath continuing to wet the hydrophilic coating as needed, and into
the access vessel. Note: If excessive resistance is felt as the delivery catheter is introduced
through the haemostasis valve, remove and inspect the delivery catheter for damage. Do
not reuse if damaged. Ensure the valved introducer sheath diameter is compatible with
the given delivery catheter outer diameter (see Table 1), and that the valved introducer
sheath is free of kinks.
Figure 3.
Junction of
Endoprosthesis
Pod and Tip
Cover Distal Tip to
Flush Endoprosthesis
Pod.
Remove Finger to Flush
Guide Wire Lumen
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