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Intended Iliac Vessel
Diameter
1,2
(mm)
8
9
10 - 12
13 - 15
16 - 18
19 - 20
1
Maximum diameter along the distal fixation site .
Round measured aortic diameter to nearest mm .
2
3
Additional considerations may affect choice of diameter .
Approximate overall leg length = label length + 28 mm .
4
*All dimensions are nominal .
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 techniques may be required .
• 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) .
• For additional anatomical requirements, please refer to the appropriate
main body or Renu IFU from the Zenith AAA family of products . A copy is
available online at www .cookmedical .com .
Prior to use of the Zenith Alpha Spiral-Z Endovascular Leg, 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 Spiral-Z Endovascular Leg . The Zenith
Alpha Spiral-Z Endovascular Leg 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 delivery system (i .e .,
define respective contralateral and ipsilateral iliac arteries) .
2 . Angulation of aortic neck, aneurysm and iliac arteries .
3 . Diameters of infrarenal aortic neck and distal iliac arteries .
4 . Length from the aortic bifurcation of a previously placed main body or
Renu from the Zenith AAA Endovascular Graft family of products to the
internal iliac arteries/attachment site(s) .
5 . Aneurysm(s) extending into the iliac arteries may require special
consideration in selecting a suitable graft/artery interface site .
6 . Consider the degree of vascular calcification, stenosis and narrowing .
Patient Preparation
1 . Refer to institutional protocols relating to anesthesia, anticoagulation
and monitoring of vital signs .
2 . Position the patient on the imaging table allowing fluoroscopic
visualization from the aortic arch to the femoral bifurcations .
3 . Expose the selected common femoral artery using standard surgical
technique .
4 . Establish adequate proximal and distal vascular control of the selected
femoral vessel .
10.1 Zenith Alpha Spiral-Z Endovascular Leg System (Fig 2)
NOTE: For directions on how to place a main body or other Zenith devices
refer to the appropriate Instructions for Use included with that Zenith device .
10.1.1 Contralateral Iliac Leg Preparation/Flush
1 . Remove the Peel-Away sheath from the back of the hemostatic valve .
(Fig . 3) Elevate the distal tip of system and flush through the stopcock
on the hemostatic valve until fluid emerges from the flushing groove
near the tip of the introducer sheath . (Fig . 4) Continue to inject a full
20 cc of flushing solution through the device . Discontinue injection and
close the stopcock on the connecting tube .
NOTE: Graft flushing solution of heparinized saline is often used .
2 . Attach a syringe with heparinized saline to the black hub of the inner
cannula . Flush until fluid exits the distal dilator tip . (Fig . 5)
NOTE: When flushing the system, elevate the distal end of system to
facilitate removal of air .
3 . Soak sterile gauze pads in saline solution and use them to wipe the
Flexor introducer sheath to activate the hydrophilic coating . Hydrate
both the sheath and dilator liberally .
10.1.2 Ipsilateral Iliac Leg Preparation/Flush
Follow the instructions in the previous section, Contralateral Iliac Leg
Preparation/Flush, to ensure proper flushing of the ipsilateral iliac leg graft
and activation of the hydrophilic coating .
10.1.3 Vascular Access and Angiography
1 . Puncture the selected common femoral arteries using standard
technique with an 18 or 19 UT gage arterial needle . Upon vessel entry,
insert:
Table 9.5.1 Zenith Alpha Spiral-Z Endovascular Leg Graft Sizing Guide*
Iliac Leg Diameter
3
(mm)
9
11
13
16
20
24
Iliac Leg Label Length
4
(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
• Wire guides – standard .035 inch diameter, 145 cm long
• Appropriate size sheaths (e .g ., 6 or 8 Fr)
• Flush catheter (often radiopaque sizing catheters – e .g ., Centimeter
Sizing Catheter or straight flush catheter)
2 . Perform angiography to identify level(s) of aortic bifurcation and iliac
bifurcations .
NOTE: If fluoroscope angulation is used with an angulated neck, it may
be necessary to perform angiograms using various projections .
10.1.4 Contralateral Iliac Leg Placement and Deployment
CAUTION: Verify that the contralateral iliac leg is selected .
NOTE: When using a 42 or 59 mm ipsilateral leg graft, contralateral leg
overlap should be limited to 16 mm .
1 . Position the image intensifier to show both the contralateral internal
iliac artery and contralateral common iliac artery .
2 . Prior to introduction of the contralateral iliac leg delivery system,
inject contrast through the contralateral femoral sheath to locate the
contralateral internal iliac artery .
3 . Remove the femoral sheath and introduce the contralateral iliac leg
delivery system into the artery . Advance slowly until the zone between
the two proximal gold markers aligns with the gold radiopaque marker
at the bifurcation of the main body graft . This will allow between
16 mm and 32 mm of overlap between components . (Fig . 6) If there is
any tendency for the main body graft to move during this maneuver,
hold it in position by stabilizing the positioner on the ipsilateral side .
NOTE: If used in conjunction with a Zenith Flex main body, Zenith Renu,
Zenith Fenestrated distal body, or Zenith Universal Distal body, advance
the introduction system slowly until the proximal gold marker of the leg
graft aligns with the proximal edge of the first limb stent . This provides
the minimum one stent overlap . Advancing the proximal gold marker an
additional one-half stent length into the limb, provides the maximum
one and one-half stent overlap .
NOTE: On each iliac leg there are three gold markers, as explained below:
Proximal Marker 1
Proximal Marker 2
Distal Marker
NOTE: If difficulty is encountered advancing the iliac leg delivery
system, exchange to a more supportive wire guide . In tortuous vessels,
the anatomy may alter significantly with the introduction of the rigid
wires and sheath systems .
4 . Confirm position of the distal end of the contralateral iliac leg graft .
Reposition the contralateral iliac leg graft if necessary to ensure both
internal iliac patency and minimum overlap of 2 stents (16 mm) within
the main body endovascular graft .
5 . To deploy, hold the contralateral iliac leg graft in position with the gray
positioner while withdrawing the sheath approximately 10 mm .
(Figs . 8 and 9)
6 . Check the graft position and reposition if necessary .
7 . Continue to deploy the graft by withdrawing the sheath while
continuously checking the position of the graft .
8 . Stop withdrawing the sheath as soon as the distal end of the contralateral
iliac leg graft is released .
9 . Under fluoroscopy and after verification of iliac leg graft position,
loosen the pin vise and retract the inner cannula to dock the tapered
dilator to the positioner . Tighten the pin vise . Maintain sheath position
while withdrawing the gray positioner with secured inner cannula .
(Fig . 10)
10 . Re-check the position of the wire guide .
10.1.5 Ipsilateral Iliac Leg Placement and Deployment
NOTE: Ensure the Captor Hemostatic Valve on the introducer sheath is
turned to the open position . (Fig . 11)
1 . Position the image intensifier to show both the ipsilateral internal iliac
artery and ipsilateral common iliac artery .
2 . Prior to the introduction of the ipsilateral iliac leg delivery system, inject
contrast through the main body femoral sheath to locate the ipsilateral
internal iliac artery .
20
Introducer Sheath
French
Size
12
12
12
12
14
14
Location
Graft Overlap
Proximal edge
When marker is aligned
with the main body
bifurcation marker, there
is an overlap of 16 mm
on the contralateral side
(minimum recommended
overlap)
16 mm from
When this marker is
proximal edge
aligned with the main
body bifurcation marker,
there is an overlap of
32 mm on the
contralateral side
(maximum recommended
overlap)
Distal edge
ID, OD
(mm)
4 .0, 4 .7
4 .0, 4 .7
4 .0, 4 .7
4 .0, 4 .7
4 .7, 5 .3
4 .7, 5 .3
N/A
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