Directions For Use; Anatomical Requirements; Proximal And Distal Component Overlap - COOK Medical ZENITH ALPHA Mode D'emploi

Table 1 — Main Body (P, D, PT) Graft Diameter Sizing Guide
Intended aortic
Vessel Diameter Diameter
1,2
(mm)
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
*All dimensions are nominal. **Non stock items.
1 Maximum diameter along the fixation site, measured outer wall to outer wall.
2 Round measured aortic diameter to nearest mm.
3 Additional considerations may affect choice of diameter
Table 2 — Distal Extension (DE) Graft Diameter Sizing Guide
Intended aortic
Vessel Diameter (mm)
1,2
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
*All dimensions are nominal. **Non stock items.
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

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 15-42 mm.
18
Graft overall Length of
Proximal Component
3
(mm) (mm)
18 105/127**
18 105/127**
20 105/127**
22 105/127**
22 105/127**
24 105/127**
24 105/127**
26 105/149**
26 105/149**
28 109/132**/155/201
28 109/132**/155/201
30 109/132**/155/201
30 109/132**/155/201
32 109/132**/155/201
32 109/132**/155/201
34 113/137**/161/209
36 113/137**/161/209
36 113/137**/161/209
38 117/142**/167/217
38 117/142**/167/217
40 117/142**/167/217
40 117/142**/167/217
42 121/147**/173/225
42 121/147**/173/225
44 125/152**/179/233
46 125/152**/179/233
46 125/152**/179/233
46 125/152**/179/233
Graft Diameter
(mm)
18
18
20
22
22
24
24
26
26
28
28
30
30
32
32
34
36
36
38
38
40
40
42
42
44
46
46
46
*
overall Length of
Distal Component (mm)
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
160/229**
160/229**
160/229**
160/229**
160/229**
160/229**
142/190
142/190
142/190
147/197
147/197
147/197
147/197
152/204
152/204
157/211
157/211
157/211
157/211
*
3 overall Length of Component
(mm)
104/148**
104/148**
104/148**
104/148**
104/148**
104/148**
104/148**
104/148**
104/148**
108/154**
108/154**
108/154**
108/154**
108/154**
108/154**
112/160**
112/160**
112/160**
91/141**
91/141**
91/141**
91/141**
94/146**
94/146**
97/151**
97/151**
97/151**
97/151**
• Proximal neck diameter that is 4 mm or more larger than the distal neck
diameter requires the use of a proximal tapered component.
• Measurements to be taken during the pre-treatment assessment are shown
in fig. 3.

Proximal and Distal Component Overlap

A minimum overlap of three stents is recommended; however, the proximal
sealing stent of the proximal component or distal sealing stent of the distal
component should not be overlapped.
overall Length of
Tapered Proximal Introducer
Component (mm) Sheath (fr)
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
178/201
178/201
161/209
161/209
161/209
167/217
167/217
167/217
167/217
173/225
173/225
179/233
179/233
179/233
179/233
Introducer Sheath
(fr)
16
16
16
16
16
16
16
16
16
16
16
16
16
18
18
18
18
18
18
18
20
20
20
20
20
20
20
20
I-ALPHA-TAA-1306-436-01
16
16
16
16
16
16
16
16
16
16
16
16
16
18
18
18
18
18
18
18
20
20
20
20
20
20
20
20