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incompatibility with accessory devices, insufficient endoprosthesis expansion, premature
deployment, endoprosthesis fracture, endoprosthesis kinking, endoprosthesis migration,
endoprosthesis misplacement, and occlusion.
NOTES
•
Before introduction into the patient, the hydrophilic coating on the WRAPSODY Delivery
Catheter must be wetted with sterile heparinized saline, and the guide wire lumen and
endoprosthesis Pod must be flushed with sterile heparinized saline.
•
Post-dilation of the implanted WRAPSODY Endoprosthesis is required with a balloon equal
in diameter to that of the selected WRAPSODY Endoprosthesis diameter.
•
Prescribed anticoagulation pre-, during and post- procedure should follow institutional
standards, including dual antiplatelet treatment if appropriate.
MRI SAFETY AND COMPATIBILTY INFORMATION
Non-clinical testing has demonstrated that the WRAPSODY Endoprosthesis is MR
Conditional. A patient with an implant from this family can be scanned safely in an MR
system under the following conditions:
•
Static magnetic field of 1.5-Tesla and 3-Tesla, only.
•
Maximum spatial gradient magnetic field of 4,000-gauss/cm (40-T/m).
•
Maximum MR system reported, whole body averaged specific absorption rate (SAR) of
2-W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating
Mode.
Under the scan conditions defined, the Merit WRAPSODY Endoprosthesis is expected to produce
a maximum temperature rise of 1.6 °C after 15 minutes of continuous scanning (i.e., per pulse
sequence).
In non-clinical testing, image artifact caused by the Merit WRAPSODY Endoprosthesis extends
approximately 3 mm from device when imaged with a gradient echo pulse sequence and a
3-Tesla MR system. The lumen of the Merit WRAPSODY Endoprosthesis can be visualized on T1-
weighted, spin echo and gradient echo pulse sequences.
CLINICAL BENEFITS
The intended clinical benefit of the WRAPSODY System is the restoration and maintenance of
blood flow through an occluded or stenosed venous dialysis outflow circuit.
MERIT WRAPSODY ENDOPROSTHESIS SIZING AND SELECTION
It is essential to ensure that the appropriate diameter and length are chosen for the WRAPSODY
Endoprosthesis prior to introduction. To ensure adequate fixation (or vessel wall apposition), it is
recommended to oversize the diameter of the WRAPSODY Endoprosthesis relative to the healthy
(non-diseased) portion of the vessel, see Table 1. The endoprosthesis selected should extend at
least 1 cm beyond the proximal and distal margins of the obstruction or dissection.
Reference
Merit
Vessel
endoprosthesis
Diameter
Diameter (mm)
1
(mm)
4.6-5.3
6
5.4-6.1
7
6.2-7.2
8
8
7.3-8.1
9
9
8.2-9.0
10
10
9.0-10.8
12
10.9-12.6
14
14
12.7-14.4
16
1 Recommended endoprosthesis compression within the vessel is approximately 10-25%
2 Labeled lengths are nominal and are measured from each extreme end of the endoprosthesis
REQUIRED SUPPLIES
•
Merit WRAPSODY Endoprosthesis System
•
Marker guide wire or catheter (for calibrated measurement reference)
•
Sterile heparinized saline and sterile saline
•
Sterile syringes
•
0.035" (0.889 mm) stiff guide wire at least twice as long as the length of the delivery
catheter system
•
Valved introducer sheath with appropriate inner diameter
•
Balloon angioplasty catheter and accessories for pre and/or post dilation
•
Guide catheters and accessories
•
Contrast medium
Delivery
Available
Catheter
endoprosthesis
Outer
Lengths
(mm)
2
Diameter
(Fr)
8
50, 75, 100, 125 0.035" (0.889
9
50, 75, 100, 125 0.035" (0.889
9
50, 75
10
100, 125
10
50, 75
11
100, 125
11
50, 75
12
100, 125
12
30, 40, 50, 60,
70, 80
12
30, 40, 50
14
60, 70, 80
14
30, 40, 50, 60,
70, 80
Table 1
Guide Wire
Delivery
Diameter
Catheter
Working
Length
(cm)
80, 120
mm)
80, 120
mm)
0.035" (0.889
80, 120
mm)
0.035" (0.889
80, 120
mm)
0.035" (0.889
80, 120
mm)
0.035" (0.889
80, 120
mm)
0.035" (0.889
120
mm)
0.035" (0.889
120
mm)
0.035" (0.889
120
mm)
0.035" (0.889
120
mm)
0.035" (0.889
120
mm)
0.035" (0.889
120
mm)
Recommended
Recommended
Balloon
Introducer
Diameter for
Sheath Size (Fr)
endoprosthesis
Touch-up (mm)
6
7
8
8
9
9
10
10
12
14
14
16
8
9
9
10
10
11
11
12
12
12
14
14
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