Directions For Use - COOK Medical Zenith TX2 Gebrauchsanweisung

9.5 Device Diameter Sizing Guidelines
The choice of diameter should be determined from the outer wall to outer wall vessel diameter and not
the lumen diameter. Undersizing or oversizing may result in incomplete sealing or compromised flow.
In order to ensure accurate diameter measurements for the purpose of graft sizing, particularly when in
curved segments of the aorta, measuring the aortic diameter using 3D reconstructed views perpendicu-
lar to the aortic centerline of flow may be important.
Table 9.1 Main Body Graft Diameter Sizing Guide*
Intended Aortic Graft Diameter
Vessel Diameter 1,2 (mm)
(mm)
20
21
22/23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
All dimensions are nominal.
*
Maximum diameter along the fixation site, measured outer wall to outer wall.
1
2 Round measured aortic diameter to nearest mm.
Additional considerations may affect choice of diameter.
3
Table 9.2 Proximal and Distal Extension Graft Diameter Sizing Guide*
Intended Aortic Vessel
Diameter (mm)
1,2
20
21
22/23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
*All dimensions are nominal.
Maximum diameter along the fixation site, measured outer wall to outer wall.
1
Round measured aortic diameter to nearest mm.
2
3 Additional considerations may affect choice of diameter.

10. DIRECTIONS FOR USE

Anatomical Requirements
• Iliofemoral access vessel size and morphology (minimal thrombus, calcium and/or tortuosity)
should be compatible with vascular access techniques and accessories. Arterial conduit technique
may be required.
• Proximal and distal aortic neck lengths should be a minimum of 20 mm.
• Aortic neck diameters measured outer wall to outer wall between 20-38 mm.
• Proximal neck diameter of at least 4 mm larger than the distal neck diameter requires the use of a
proximal tapered component.
• Measurements to be taken during the pre-treatment assessment are described in Fig. 5 and 6.
I-TX2-PRO-FORM-1002-361-02
Overall Length of
3
Proximal Component
(mm)
22 115
24 115
26 115
28 120/140/200
30 120/140/200
30 120/140/200
30 120/140/200
32 120/140/200
32 120/140/200
34 127/152/202
36 127/152/202
36 127/152/202
38 127/152/202
38 127/152/202
40 135/162/216
40 135/162/216
42 135/162/216
42 135/162/216
Graft Diameter (mm)
3
22
24
26
28
30
30
30
32
32
34
36
36
38
38
40
40
42
42
Overall Length of Overall length of
Distal Component Proximal Tapered
(mm) Component (mm)
NA
NA
NA
147/207
147/207
147/207
147/207
147/207
147/207
136/186
136/186
136/186
136/186
136/186
144/198
144/198
144/198
144/198
Overall Length of Component (mm)
80
80
80
80
80
80
80
80
80
77
77
77
77
77
81
81
81
81
Introducer Sheath
(Fr)
NA 20
NA 20
NA 20
N/A 20
N/A 20
N/A 20
N/A 20
160/200 20
160/200 20
157/197 20
157/197 22
157/197 22
152/202 22
152/202 22
158/208 22
158/208 22
158/208 22
158/208 22
Introducer Sheath (Fr)
20
20
20
20
20
20
20
20
20
20
22
22
22
22
22
22
22
22
Introducer Sheath
Outer Diameter
(OD) (mm)
7,7
7,7
7,7
7.7
7.7
7.7
7.7
7.7
7.7
7.7
8.6
8.6
8.6
8.6
8.6
8.6
8.6
8.6
Introducer Sheath
Outer Diameter
(OD) (mm)
7,7
7.7
7,7
7.7
7.7
7.7
7.7
7.7
7.7
7.7
8.6
8.6
8.6
8.6
8.6
8.6
8.6
8.6
ENGLISH 7