Powerlink® System for AAA Visiflex SurePass Delivery ... - Endologix
Powerlink® System for AAA Visiflex SurePass Delivery ... - Endologix
Powerlink® System for AAA Visiflex SurePass Delivery ... - Endologix
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Powerlink ® <strong>System</strong> <strong>for</strong> <strong>AAA</strong><br />
<strong>Visiflex</strong> <strong>SurePass</strong> <strong>Delivery</strong> <strong>System</strong><br />
Deployment Technique
Powerlink ®<br />
<strong>Visiflex</strong> <strong>SurePass</strong><br />
<strong>Delivery</strong> <strong>System</strong> Components<br />
<strong>SurePass</strong> Wire - connects to the Contralateral<br />
Limb Cover. Pull it to deploy the contralateral limb.<br />
Ability to pass a guide<br />
wire through a hollow<br />
lumen to maintain<br />
contralateral access.<br />
Pusher Rod – connects to the<br />
Front Sheath. Advance it to<br />
deploy the main body.<br />
Front Sheath –<br />
covers the main<br />
body of the stent<br />
graft.<br />
White Hub – connects to the Outer<br />
Sheath. Pull it to release the limbs.<br />
1<br />
Red Hub – connects to the Radiopaque Front<br />
Stop on the Middle Core, and facilitates<br />
retraction of the Front Sheath.
Deployment Procedure<br />
First, per<strong>for</strong>m a cut-down on the access vessel using standard<br />
surgical technique.<br />
Insert a 12.5F tear-away sheath into the ipsi vessel, and a 9F<br />
sheath into the contra side.<br />
If necessary, insert a marker pigtail catheter and per<strong>for</strong>m an<br />
angiogram to measure vessel lengths and scout areas of potential<br />
troubleshooting.<br />
2
Insert a snare into the aorta through the ipsi tear-away sheath, and<br />
advance a floppy wire up the contra side.<br />
Snare and pull the wire through the ipsi side.<br />
3
Advance the Dual Lumen Catheter (DLC) up the contra and out the<br />
ipsi side.<br />
Advance a stiff wire through the DLC skives into the thoracic<br />
aorta.<br />
Position the DLC skive marker at the ipsi common iliac artery just<br />
over the bifurcation.<br />
4
Load the delivery system onto the stiff wire, and keep the side<br />
port medial.<br />
Remove the DLC from the contra side, and snap and peel away<br />
the ipsi sheath.<br />
Remove the floppy wire from the DLC, and advance the <strong>SurePass</strong><br />
wire up the ipsi DLC central lumen.<br />
5
Advance the delivery system into the aorta under fluoro, and<br />
position the stent graft distal end above the aortic bifurcation.<br />
Release the limbs:<br />
Loosen the White Hub, then stabilize the Red Hub while pulling<br />
White completely to Red.<br />
6
Re-advance the White Hub to recapture the ipsi limb, and tighten<br />
the White Hub.<br />
Gently pull out slack in the <strong>SurePass</strong> wire.<br />
While buttressing the White Hub with your thumb, pull the entire<br />
delivery system to bring the Front Stop below the lowest renal<br />
artery.<br />
Guide the contra limb into the contra iliac.<br />
7
Deploy the main body:<br />
Loosen the Red Hub, then stabilize it and advance the Pusher Rod<br />
completely. Tighten the Red Hub.<br />
Advance a .014” wire through the <strong>SurePass</strong> wire into the thoracic<br />
aorta to maintain contralateral wire access.<br />
Retract the Front Sheath:<br />
Stabilize the White Hub, and pull the Red Hub until the Front Stop<br />
is slightly above the aortic bifurcation.<br />
8
Deploy the ipsi limb in steps:<br />
Loosen the White Hub, then stabilize the Red Hub and pull White<br />
to deploy half of the ipsi limb.<br />
Repeat this maneuver to fully deploy the ipsi limb, then pull the<br />
Red Hub until both radiopaque markers are 1cm apart over the<br />
Front Stop.<br />
Pull the Red Hub to bring the Front Stop inside the limb.<br />
9
Pull the <strong>SurePass</strong> wire until the contra limb is fully deployed, and<br />
maintain .014” wire position while removing it.<br />
Exchange a pigtail catheter over the .014” wire, and per<strong>for</strong>m a<br />
completion angiogram.<br />
Remove the delivery system by pulling only on the Red Hub.<br />
10
The fully deployed Powerlink stent graft delivered with the <strong>Visiflex</strong><br />
<strong>SurePass</strong> <strong>Delivery</strong> <strong>System</strong>.<br />
11
Telephone: 949.595.7200<br />
Customer Service: 800.983.2284<br />
Fax: 949.830.4463<br />
customerservice@endologix.com<br />
www.endologix.com<br />
See product “Instructions <strong>for</strong> Use” <strong>for</strong> specific and<br />
complete prescribing in<strong>for</strong>mation.<br />
MM0001 REV. D