Graft Diameter Sizing Guide; Directions For Use; Anatomical Requirements; General Use Information - COOK Medical Zenith Alpha Mode D'emploi

Table 9 .5 .1 Main Body, ZIMB (Zenith Alpha Abdominal Main Body), Graft Diameter Sizing Guide*
Intended Aortic Vessel
1,2
Diameter
(mm)
18-19
20-21
22
23-24
25-26
27-28
29-32
1
Maximum diameter along the proximal fixation site.
2
Round measured aortic diameter to nearest mm.
3
Additional considerations may affect choice of diameter.
* All dimensions are nominal.
Table 9 .5 .2 Iliac Leg, ZISL (Zenith Alpha Spiral-Z Endovascular Leg), Graft Diameter Sizing Guide*
Intended Iliac Vessel
1,2
Diameter
(mm)
8
9
10-12
13-15
16-18
19-20
1
Maximum diameter along the distal fixation site.
2
Round measured iliac diameter to nearest mm.
3
Additional considerations may affect choice of diameter.
4
Approximate overall leg length = label length + 28 mm.
*AII dimensions are nominal.
Table 9 .5 .3 Main Body Extension, ZLBE (Zenith Low Profile/Zenith Alpha Abdominal Body Extension), Graft Diameter Sizing Guide*
Intended Aortic Vessel
1,2
Diameter
(mm)
18-19
20-21
22
23-24
25-26
27-28
29-32
1
Maximum diameter along the proximal fixation site.
2
Round measured aortic diameter to nearest mm.
3
Additional considerations may affect choice of diameter.
*AII dimensions are nominal.
Table 9 .5 .4 Converter, ZLC (Zenith Low Profile/Zenith Alpha Abdominal Converter), Graft Diameter Sizing Guide*
Main Body
Diameter
(mm)
22 & 24
26 & 28
30 & 32
36
1
Additional considerations may affect choice of diameter.
*AII dimensions are nominal.

10 DIRECTIONS FOR USE

Anatomical Requirements

• Iliofemoral access vessel size and morphology (minimal thrombus,
calcification and/or tortuosity) should be compatible with vascular access
techniques and accessories . Arterial conduit techniques may be required .
• Proximal aortic neck lengths should be a minimum of 15 mm with a
diameter measured outer wall to outer wall of 18 to 32 mm .
• Iliac artery distal fixation site should be greater than 10 mm in length
and 8 to 20 mm in diameter (measured outer wall to outer wall) .
Prior to use of the Zenith Alpha Abdominal Endovascular Graft, review this
Suggested Instructions for Use booklet . The following instructions embody a
guideline for device placement . Variations in the following procedures may
be necessary . These instructions are intended to help guide the physician
and do not take the place of physician judgment .

General Use Information

• Standard techniques for placement of arterial access sheaths, guiding
catheters, angiographic catheters and wire guides should be employed
during use of the Zenith Alpha Abdominal Endovascular Graft . The
Zenith Alpha Abdominal Endovascular Graft is compatible with .035 inch
diameter wire guides .
Main Body
3
Diameter
(mm)
22
24
26
28
30
32
36
Iliac Leg
3
Diameter
(mm)
9
11
13
16
20
24
Main Body Extension
3
Diameter
(mm)
22
24
26
28
30
32
36
Converter
1
Diameter
(mm)
24
28
32
36
Overall Length to Contralateral Limb/
Overall Length to Ipsilateral Limb
(mm)
70/94, 84/108, 98/122, 108/132, 118/142, 128/152
70/94, 84/108, 98/122, 108/132, 118/142, 128/152
70/94, 84/108, 98/122, 108/132, 118/142, 128/152
70/94, 84/108, 98/122, 108/132, 118/142, 128/152
70/94, 84/108, 98/122, 108/132, 118/142, 128/152
70/94, 84/108, 98/122, 108/132, 118/142, 128/152
70/94, 84/108, 98/122, 108/132, 118/142, 128/152
Iliac Leg
Label Length
(mm)
42, 59, 77, 93, 110, 125
42, 59, 77, 93, 110, 125
42, 59, 77, 93, 110, 125
42, 59, 77, 93
42, 59, 77, 93
42, 59, 77, 93
Main Body Extension Length
(mm)
45, 58
45, 58
45, 58
45, 58
45, 58
45, 58
45, 58
Converter Length
(mm)
66
66
66
66
• Endovascular stent grafting is a surgical procedure, and blood loss from
various causes may occur, infrequently requiring intervention (including
transfusion) to prevent adverse outcomes . It is important to monitor
blood loss from the hemostatic valve throughout the procedure, but is
specifically relevant during and after manipulation of the gray positioner .
After the gray positioner has been removed, if blood loss is excessive,
consider placing an uninflated molding balloon or an introduction
system dilator within the valve, restricting flow .

Pre-Implant Determinants

Verify from pre-implant planning that the correct device has been selected .
Determinants include:
1 . Femoral artery selection for introduction of the main body system (i .e .,
define respective contralateral and ipsilateral iliac arteries) .
2 . Angulation of the aortic neck, aneurysm and iliac arteries .
3 . Quality of the aortic neck .
4 . Diameters of the infrarenal aortic neck and distal iliac arteries .
5 . Distance from the renal arteries to the aortic bifurcation .
6 . Length from the aortic bifurcation to the internal iliac arteries/
attachment site(s) .
7 . Aneurysm(s) extending into the iliac arteries may require special
consideration in selecting a suitable graft/artery interface site .
8 . Consider the degree of vascular calcification, stenosis and narrowing .
30
4
Introducer Sheath
French ID, OD
Size (mm)
16 5 .3, 6 .0
16 5 .3, 6 .0
16 5 .3, 6 .0
16 5 .3, 6 .0
16 5 .3, 6 .0
16 5 .3, 6 .0
17 5 .6, 6 .5
Introducer Sheath
French ID, OD
Size (mm)
12 4 .0, 4 .7
12 4 .0, 4 .7
12 4 .0, 4 .7
12 4 .0, 4 .7
14 4 .7, 5 .3
14 4 .7, 5 .3
Introducer Sheath
French ID, OD
Size (mm)
16 5 .3, 6 .0
16 5 .3, 6 .0
16 5 .3, 6 .0
16 5 .3, 6 .0
16 5 .3, 6 .0
16 5 .3, 6 .0
17 5 .6, 6 .5
Introducer Sheath
French ID, OD
Size (mm)
16 5 .3, 6 .0
16 5 .3, 6 .0
16 5 .3, 6 .0
17 5 .6, 6 .5