Endovascular AAA System - Endologix
Endovascular AAA System - Endologix
Endovascular AAA System - Endologix
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<strong>Endovascular</strong> <strong>AAA</strong> <strong>System</strong>
full Range<br />
Treats necks up to 32 mm<br />
and iliacs up to 23 mm.<br />
Suprarenal Proximal Extension<br />
80 mm<br />
20 mm<br />
23-32 mm<br />
Vessel Diameter<br />
Simple Sizing<br />
Build from the one-piece<br />
main body.<br />
34 mm<br />
25 & 28 mm<br />
20 mm<br />
18-26 mm<br />
Vessel Diameter<br />
55 mm<br />
Limb Extension<br />
55 & 75 mm<br />
20 mm<br />
18-26 mm<br />
Vessel Diameter<br />
18-26 mm<br />
Vessel Diameter<br />
16 mm<br />
55 & 88 mm<br />
40 & 55 mm<br />
25 & 28 mm<br />
55 & 75 mm<br />
10 - 18 mm<br />
vessel diameter<br />
80 & 100 mm<br />
25 & 28 mm<br />
16 mm<br />
Infrarenal Bifurcated Stent Graft<br />
34 mm<br />
Flared Limb Extension<br />
65 mm<br />
20 mm<br />
80 mm<br />
25 mm<br />
20 mm<br />
Infrarenal Proximal Extension<br />
23-32 mm<br />
Vessel Diameter<br />
14-23 mm<br />
vessel Diameter<br />
25 mm<br />
65 mm<br />
Stepped Limb Extension
THE PERFECT PLACEMENT<br />
Anatomical Fixation<br />
Placement on the aortic<br />
bifurcation provides a firm<br />
foundation to inhibit migration.<br />
1<br />
SurePass<br />
Save time with a pre-cannulated<br />
contralateral limb.<br />
position proximal extension<br />
Deploy main body<br />
3<br />
2<br />
CONTROL & ACCURACY<br />
Partial deployment enables<br />
precise placement below renal<br />
arteries.<br />
Iliac Access<br />
Ipsilateral Introducer, 19F<br />
Contralateral Sheath, 9F
19F Integrated Introducer...<br />
One Sheath. Multiple Applications.<br />
main body<br />
Virtually eliminate sheath exchange<br />
and simplify your <strong>AAA</strong> procedure.<br />
Hemostasis valve<br />
Lowest profile to treat<br />
large neck <strong>AAA</strong>s.<br />
Complete control to minimize<br />
blood loss.<br />
Locking hub<br />
Connect extension system<br />
to introducer sheath for<br />
simplified deployment.<br />
hydrophilic coating<br />
Ease of access through tortuous<br />
vessels for smooth delivery.<br />
Full Range of extensions<br />
Treat necks up to 32 mm and<br />
iliacs up to 23 mm.<br />
Accurate placement of proximal<br />
and limb extensions.<br />
Versatility<br />
Perform balloon dilitation and<br />
angiogram without sheath<br />
exchanges.
Powerlink ® Six-year clinical results*<br />
IntuiTrak Profile Comparison (OD)*<br />
0% Rupture<br />
0% Stent Fracture or Graft Failure<br />
97.9% Freedom from <strong>AAA</strong>-Related Mortality<br />
83% with Significantly Reduced Sac Diameter<br />
Aortic Neck Diameter (mm)<br />
<strong>Endologix</strong> ® IntuiTrak <br />
18 19 20 21 22 23 24 25 26 27 28 29 30 31 32<br />
21F<br />
Medtronic ® Talent 22F 24F<br />
Pre-op<br />
One Year<br />
six Year<br />
Cook ® Zenith ® 21F 23F 24.5F<br />
Gore ® Excluder ® N/A 20.4F 23F N/A<br />
* All profile information per manufacturer’s IFU on FDA website http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm<br />
® and - All names are trademarks of their respective owners.<br />
Powerlink XL ® One-year clinical results<br />
0% Migration, Rupture or Conversion<br />
0% Stent Fracture or Graft Failure<br />
Procedural Characteristics<br />
Mean values shown<br />
94.9% Survival<br />
96% Significantly Reduced or Stable Aneurysm Sac Diameter<br />
IntuiTrak Powerlink ®<br />
Experience *† PMA<br />
Talent <br />
PMA<br />
Zenith ®<br />
PMA<br />
Excluder ®<br />
PMA<br />
Blood Loss, mL 209 341 * 335 * 299 * 310 *<br />
Contrast Used, mL 128 189 * 153 * nr nr<br />
Procedure Time, min 109 136 * 167 * 153 * 144 *<br />
Pre-op<br />
ONE Year<br />
Two Year<br />
† IntuiTrak clinical evaluation, N=112. Data on file. All other results obtained from the respective FDA summary of safety and effectiveness data.<br />
* P
The Powerlink ® <strong>System</strong><br />
Multiple Treatment Options to Accomodate Patient’s Anatomy<br />
Model Number<br />
Description<br />
Proximal Diameter<br />
Distal Diameter<br />
Bifurcated Body Length<br />
Bifurcated Limb Length<br />
Total Stent Length<br />
Covered Stent Length<br />
Open Stent Length<br />
Introducer Sheath Size<br />
Delivery <strong>System</strong> Outer Diameter<br />
Bifurcated<br />
Devices<br />
28-16-155BL Infrarenal Bifurcated Stent Graft 28 16 100 55 155 155 19 Fr 21 Fr<br />
28-16-140BL Infrarenal Bifurcated Stent Graft 28 16 100 40 140 140 19 Fr 21 Fr<br />
28-16-135BL Infrarenal Bifurcated Stent Graft 28 16 80 55 135 135 19 Fr 21 Fr<br />
28-16-120BL Infrarenal Bifurcated Stent Graft 28 16 80 40 120 120 19 Fr 21 Fr<br />
25-16-155BL Infrarenal Bifurcated Stent Graft 25 16 100 55 155 155 19 Fr 21 Fr<br />
25-16-140BL Infrarenal Bifurcated Stent Graft 25 16 100 40 140 140 19 Fr 21 Fr<br />
25-16-135BL Infrarenal Bifurcated Stent Graft 25 16 80 55 135 135 19 Fr 21 Fr<br />
25-16-120BL Infrarenal Bifurcated Stent Graft 25 16 80 40 120 120 19 Fr 21 Fr<br />
Suprarenal<br />
Extensions<br />
34-34-100RLE Suprarenal Extension 34 34 100 80 20<br />
34-34-100RL Suprarenal Extension 34 34 100 80 20 19 Fr 21 Fr<br />
28-28-95RL Suprarenal Extension 28 28 95 75 20 19 Fr<br />
28-28-75RL Suprarenal Extension 28 28 75 55 20 19 Fr<br />
25-25-95RL Suprarenal Extension 25 25 95 75 20 19 Fr<br />
25-25-75RL Suprarenal Extension 25 25 75 55 20 19 Fr<br />
Infrarenal<br />
Extensions<br />
34-34-80LE Infrarenal Extension 34 34 80 80<br />
34-34-80L Infrarenal Extension 34 34 80 80 19 Fr 21 Fr<br />
28-28-75L Infrarenal Extension 28 28 75 75 19 Fr<br />
28-28-55L Infrarenal Extension 28 28 55 55 19 Fr<br />
25-25-75L Infrarenal Extension 25 25 75 75 19 Fr<br />
25-25-55L Infrarenal Extension 25 25 55 55 19 Fr<br />
Limb<br />
Extensions<br />
20-25-65F Flared Limb Extension 20 25 65 65 19 Fr<br />
20-25-65S Stepped Limb Extension 20 25 65 65 19 Fr<br />
20-20-55L Limb Extension 20 20 55 55 17 Fr<br />
16-16-88L Limb Extension 16 16 88 88 17 Fr<br />
16-16-55L Limb Extension 16 16 55 55 17 Fr<br />
Ancillary<br />
Products<br />
DL-35-90<br />
HLS-1012.5<br />
Dual Lumen Catheter (90 cm total length)<br />
12.5 Fr Tear-Away Sheath (packaged and sold in boxes of 5 each)<br />
Telephone: 949.595.7200<br />
Customer Service: 800.983.2284<br />
Fax: 877.843.1500<br />
Email: customerservice@endologix.com<br />
www.endologix.com<br />
See Product “Instructions For Use” for complete warnings, cautions, contraindications, and specific prescribing information.<br />
© Copyright 2009, <strong>Endologix</strong>, Inc. All rights reserved. MM0107 Rev.C
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