29
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 .
•
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 .
Table 9 .5 .1 Main Body, ZIMB (Zenith Alpha Abdominal Main Body), Graft Diameter Sizing Guide*
Intended Aortic Vessel
Diameter
1,2
(mm)
Main Body
Diameter
3
(mm)
Overall Length to Contralateral Limb/
Overall Length to Ipsilateral Limb
(mm)
Introducer Sheath
French
Size
ID, OD
(mm)
18-19
22
70/94, 84/108, 98/122, 108/132, 118/142, 128/152
16
5 .3, 6 .0
20-21
24
70/94, 84/108, 98/122, 108/132, 118/142, 128/152
16
5 .3, 6 .0
22
26
70/94, 84/108, 98/122, 108/132, 118/142, 128/152
16
5 .3, 6 .0
23-24
28
70/94, 84/108, 98/122, 108/132, 118/142, 128/152
16
5 .3, 6 .0
25-26
30
70/94, 84/108, 98/122, 108/132, 118/142, 128/152
16
5 .3, 6 .0
27-28
32
70/94, 84/108, 98/122, 108/132, 118/142, 128/152
16
5 .3, 6 .0
28-32
36
70/94, 84/108, 98/122, 108/132, 118/142, 128/152
17
5 .6, 6 .5
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
Diameter
1,2
(mm)
Iliac Leg
Diameter
3
(mm)
Iliac Leg
Label Length
4
(mm)
Introducer Sheath
French
Size
ID, OD
(mm)
8
9
42, 59, 77, 93, 110, 125
12
4 .0, 4 .7
9-10
11
42, 59, 77, 93, 110, 125
12
4 .0, 4 .7
11-12
13
42, 59, 77, 93, 110, 125
12
4 .0, 4 .7
13-15
16
42, 59, 77, 93
12
4 .0, 4 .7
16-18
20
42, 59, 77, 93
14
4 .7, 5 .3
19-20
24
42, 59, 77, 93
14
4 .7, 5 .3
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 26 mm.
*AII dimensions are nominal.
Table 9 .5 .3 Main Body Extension, ZLBE (Zenith Low Profile Body Extension), Graft Diameter Sizing Guide*
Intended Aortic Vessel
Diameter
1,2
(mm)
Main Body Extension
Diameter
3
(mm)
Main Body Extension Length
(mm)
Introducer Sheath
French
Size
ID, OD
(mm)
18-19
22
45, 58
16
5 .5, 6 .0
20-21
24
45, 58
16
5 .5, 6 .0
22
26
45, 58
16
5 .5, 6 .0
23-24
28
45, 58
16
5 .5, 6 .0
25-26
30
45, 58
16
5 .5, 6 .0
27-28
32
45, 58
16
5 .5, 6 .0
29-32
36
45, 58
17
5 .6, 6 .5
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 Converter), Graft Diameter Sizing Guide*
Main Body
Diameter
(mm)
Converter
Diameter
1
(mm)
Converter Length
(mm)
Introducer Sheath
French
Size
ID, OD
(mm)
22 & 24
24
66
16
5 .5, 6 .0
26 & 28
28
66
16
5 .5, 6 .0
30 & 32
32
66
16
5 .5, 6 .0
36
36
66
17
5 .6, 6 .5
1
Additional considerations may affect choice of diameter.
*AII dimensions are nominal.
