Reference List - Gore Medical

B e s t l e g si n t h e b u s i n e s s
OCCLUSION
KINKING
GORE ® EXCLUDER ®
AAA Endoprosthesis 0.65% 0.43%
Endologix PowerLink ® System 1.96%* 0.52%*
Medtronic Talent
Abdominal Stent Graft 3.12% 1.24%
BEFORE
Medtronic AneuRx
AAAdvantage ® Stent Graft 3.34% 2.42%
Cook Zenith ® AAA
Endovascular Graft 3.42% 2.97%
*Smallest limb = 16 mm
AFTER
P E R F O R M A N C E t h r o u g h d a t a
A PubMed ® search of all EVAR literature since 2001 generated 64 peer-reviewed publications 1 that
report on limb patency and / or limb kinking for EVAR devices and met basic criteria for inclusion in
this meta-analysis. The inclusion criteria for these publications was a minimum of 40 patients and
follow-up of greater than one year.
GORE ® EXCLUDER ® AAA Endoprosthesis limbs provide the flexibility and long-term conformability
that is needed to maintain patency. A unique combination of advanced sinusoidal stent design, ultra
smooth ePTFE graft material, and sutureless attachment between the two enables these limbs to flex
where others may kink.
Limbs crossed or uncrossed – with GORE ® EXCLUDER ® AAA Endoprosthesis you choose the best
option for your procedure and your patient.
1
For the complete list of references, please visit www.goremedical.com/AAAbestlegs.
INDICATIONS FOR USE: Trunk-Ipsilateral Leg Endoprosthesis and Contralateral Leg Endoprosthesis Components. The GORE EXCLUDER ®
AAA Endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic
aneurysm (AAA) disease and who have appropriate anatomy as described below: adequate iliac / femoral access, infrarenal aortic neck
treatment diameter range of 19 – 29 mm and a minimum aortic neck length of 15 mm, proximal aortic neck angulation < 60°, iliac artery
treatment diameter range of 8 – 18.5 mm and iliac distal vessel seal zone length of at least 10 mm. Aortic Extender Endoprosthesis and
Iliac Extender Endoprosthesis Components. The GORE EXCLUDER ® Extender Endoprostheses (Aortic and Iliac) are intended to be used
after deployment of the GORE EXCLUDER ® AAA Endoprosthesis. These extensions are intended to be used when additional length and
/ or sealing for aneurysmal exclusion is desired. Contraindications: There are no known contraindications for these devices. Refer to
Instructions for Use at goremedical.com for a complete description of all warnings, precautions and adverse events.
W. L. Gore & Associates, Inc. • Flagstaff, AZ 86004 • goremedical.com
Products listed may not be available in all markets. GORE ® , EXCLUDER ® , PERFORMANCE THROUGH DATA, and designs are trademarks
of W. L. Gore & Associates. AneuRx ® AAADAVANTAGE and Talent are trademarks of Medtronic, Inc. PowerLink ® is a trademark of
Endologix, Inc. PubMed ® is a registered trademark of the U.S. National Library of Medicine. Zenith ® is a trademark of Cook Medical, Inc.
©2010 W. L. Gore & Associates, Inc. AP0395-EN2 JUNE 2010

1. Carpenter JP; Endologix Investigators. Midterm results of the multicenter trial of the Powerlink bifurcated system for endovascular aortic aneurysm repair.
Journal of Vascular Surgery 2004;40(5):849-859.
2. Albertini JN, Lahlou Z, Magnan PE, Branchereau A; French Powerlink Multicenter Trial Investigators. Endovascular repair of abdominal aortic aneurysms
with a unibody stent-graft: 3-year results of the French Powerlink Multicenter Trial. Journal of Endovascular Therapy 2005;12(6):629-637.
3. Qu L, Raithel D. Experience with the Endologix Powerlink Endograft in endovascular repair of abdominal aortic aneurysms with short and angulated necks.
Perspectives in Vascular Surgery & Endovascular Therapy 2008;20(2):158-166.
4. Coppi G, Silingardi R, Tasselli S, Gennai S, Saitta G, Veraldi GF. Endovascular treatment of abdominal aortic aneurysms with the Powerlink Endograft
System: influence of placement on the bifurcation and use of a proximal extension on early and late outcomes. Journal of Vascular Surgery
2008;48(4):795-801.
5. Wang GJ, Carpenter JP; Endologix Investigators. The Powerlink system for endovascular abdominal aortic aneurysm repair: six-year results. Journal of
Vascular Surgery 2008;48(3):535-545.
6. Qu L, Raithel D. From clinical trials to clinical practice: 612 cases treated with the Powerlink stent-graft for endovascular repair of AAA. Journal of
Cardiovascular Surgery 2009;50(2):131-137.
7. Biebl M, Hakaim AG, Oldenburg WA, et al. Midterm results of a single-center experience with commercially available devices for endovascular aneurysm
repair. Mount Sinai Journal of Medicine 2005;72(2):127-135.
8. Parra JR, Crabtree T, McLafferty RB, et al. Anesthesia technique and outcomes of endovascular aneurysm repair. Annals of Vascular Surgery
2005;19(1):123-129.
9. van Marrewijk CJ, Leurs LJ, Vallabhaneni SR, Harris PL, Buth J, Laheij RJF; EUROSTAR collaborators. Risk-adjusted outcome analysis of endovascular
abdominal aortic aneurysm repair in a large population: how do stent-grafts compare? Journal of Endovascular Therapy 2005;12(4):417-429.
10. van Herwaarden JA, van de Pavoordt EDWM, Waasdorp EJ, et al. Long-term single-center results with AneuRx endografts for endovascular abdominal aortic
aneurysm repair. Journal of Endovascular Therapy 2007;14(3):307-317.
11. Smith S, Mountcastle S, Burridge A, et al. A single-institution experience with the AneuRx Stent Graft for endovascular repair of abdominal aortic
aneurysm. Annals of Vascular Surgery 2008;22(2):221-226.
12. Abbruzzese TA, Kwolek CJ, Brewster DC, et al. Outcomes following endovascular abdominal aortic aneurysm repair (EVAR): an anatomic and device-specific
analysis. Journal of Vascular Surgery 2008;48(1):19-28.
13. Noll RE Jr, Tonnessen BH, Kim J, Money SR, Sternbergh WC III. Long-term postplacement cost comparison of AneuRx and Zenith endografts. Annals of
Vascular Surgery 2008;22(6):710-715.
14. AbuRahma AF, Stone PA, Bates MC, Khan TN, Prigozen JM, Welch CA. Endovascular repair of abdominal aortic aneurysms using 3 commercially available
devices: midterm results. Journal of Endovascular Therapy 2004;11(6):641-648.
15. Peterson BG, Matsumura JS, Brewster DC, Makaroun MS. Five-year report of a multicenter controlled clinical trial of open versus endovascular treatment of
abdominal aortic aneurysms. Journal of Vascular Surgery 2007;45(5):885-890.
16. Haider SE, Najjar SF, Cho J-S, et al. Sac behavior after aneurysm treatment with the Gore Excluder low-permeability aortic endoprosthesis: 12-month
comparison to the original Excluder device. Journal of Vascular Surgery 2006;44(4):694-700.
17. Bos WT, Tielliu IF, Sondakh AO, Vourliotakis G, Bracale UM, Verhoeven EL. Hybrid endograft solution for complex iliac anatomy: zenith body and excluder
limbs. Vascular 2010;18(3):136-140.
18. Mendonça CT, de Carvalho CA, Weingärtner J, et al. Endovascular treatment of abdominal aortic aneurysms in high-surgical-risk patients using
commercially available stent-grafts. Journal of Endovascular Therapy 2010;17(1):89-94.
19. Maleux G, Koolen M, Heye S, Nevelsteen A. Limb occlusion after endovascular repair of abdominal aortic aneurysms with supported endografts. Journal of
Vascular & Interventional Radiology 2008;19(10):1409-1412.
20. Van Bindsbergen L, Dolmans DEJGJ, Greenen GPJ, et al. Endovascular aneurysm repair with Zenith ® graft. Complications caused by leg extensions. Journal
of Cardiovascular Surgery 2008;49(3):311-316.
21. Sivamurthy N, Schneider DB, Reilly LM, Rapp JH, Skovobogatvy H, Chuter TAM. Adjunctive primary stenting of Zenith endograft limbs during endovascular
abdominal aortic aneurysm repair: Implications for limb patency. Journal of Vascular Surgery 2006;43(4):662-670.
22. Cochennec F, Becquemin JP, Desgranges P, Allaire E, Kobeiter H, Roudot-Thorval F. Limb graft occlusion following EVAR: clinical pattern, outcomes and
predictive factors of occurrence. European Journal of Vascular & Endovascular Surgery 2007;34(1):59-65.
23. Becquemin JP, Aksoy M, Marzelle J, et al. Abdominal aortic aneurysm sac behavior following Cook Zenith graft implantation: a five-year follow-up
assessment of 212 cases. Journal of Cardiovascular Surgery 2008;49(2):199-206.
24. Hugl B, Hakaim AG, Biebl M, et al; Zenith Investigators. Impact of gender on the outcome of endovascular aortic aneurysm repair using the Zenith stentgraft:
midterm results. Journal of Endovascular Therapy 2007;14(2):115-121.
25. McDonnell CO, Semmens JB, Allen YB, Jansen SJ, Brooks DM, Lawrence-Brown MM. Large iliac arteries: a high-risk group for endovascular aortic aneurysm
repair. Journal of Endovascular Therapy 2007;14(5):625-629.
26. Lalka S, Dalsing M, Cikrit D, et al. Secondary interventions after endovascular abdominal aortic aneurysm repair. The American Journal of Surgery
2005;190(5):787-794.
27. Greenberg RK, Chuter TAM, Sternbergh WC III, Fearnot NE. Zenith AAA endovascular graft: intermediate-term results of the US multicenter trial. Journal of
Vascular Surgery 2004;39(6):1209-1218.
28. Bos WTGJ, Tielliu IFJ, van den Dungen JJAM, et al. Results of endovascular abdominal aortic aneurysm repair with selective use of the Gore Excluder. Journal
of Cardiovascular Surgery 2009;50(2):159-164.
29. Oshin OA, Fisher RK, Williams LA, et al. Adjunctive iliac stents reduce the risk of stent-graft limb occlusion following endovascular aneurysm repair with the
Zenith stent-graft. Journal of Endovascular Therapy 2010;17(1):108-114.
30. Jean-Baptiste E, Batt M, Azzaoui R, Koussa M, Hassen-Khodja R, Haulon S. A comparison of the mid-term results following the use of bifurcated and aortouni-iliac
devices in the treatment of abdominal aortic aneurysms. European Journal of Vascular & Endovascular Surgery 2009;38(3):298-304.
31. Hingorani AP, Ascher E, Marks N, et al. Iatrogenic injuries of the common femoral artery (CFA) and external iliac artery (EIA) during endograft placement: an
underdiagnosed entity. Journal of Vascular Surgery 2009;50(3):505-509.
32. Coppi G, Silingardi R, Saitta G, Gennai S. Single-center experience with the Talent LPS endograft in patients with at least 5 years of follow-up. Journal of
Endovascular Therapy 2008;15(1):23-32.
33. Seriki DM, Ashleigh RJ, Butterfield JS, et al. Midterm follow-up of a single-center experience of endovascular repair of abdominal aortic aneurysms with use
of the Talent stent-graft. Journal of Vascular & Interventional Radiology 2006;17(6):973-977.
34. Torsello G, Osada N, Florek H-J, et al. Long-term outcome after Talent endograft implantation for aneurysms of the abdominal aorta: a multicenter
retrospective study. Journal of Vascular Surgery 2006;43(2):277-284.
35. England A, Butterfield JS, McCollum CN, Ashleigh RJ. Endovascular aortic aneurysm repair with the talent stent-graft: outcomes in patients with large iliac
arteries. Cardiovascular & Interventional Radiology 2008;31(4):723-727.

36. Wales L, Dunckley M, Bohm N, et al. Device-specific outcomes following endovascular aortic aneurysm repair. European Journal of Vascular &
Endovascular Surgery 2008;36(6):661-667.
37. Saratzis N, Antonitsis P, Melas N, et al. Midterm results of endovascular abdominal aortic aneurysm repair with Talent stent graft in a single center.
International Angiology 2006;25(2):197-203.
38. Turnbull IC, Criado FJ, Sanchez L, et al. Five-year results for the Talent enhanced Low Profile System abdominal stent graft pivotal trial including early and
long-term safety and efficacy. Journal of Vascular Surgery 2010;51(3):537-544.
39. Pitton MB, Scheschkowski T, Ring M, et al. Ten-year follow-up of endovascular aneurysm treatment with Talent stent-grafts. Cardiovascular &
Interventional Radiology 2009;32(5):906-917.
40. Espinosa G, Ribeiro Alves M, Ferreira Caramalho M, Dzieciuchowicz L, Santos SR. A 10-year single-center prospective study of endovascular abdominal
aortic aneurysm repair with the Talent Stent-Graft. Journal of Endovascular Therapy 2008;16(2):125-135.
41. Cao P, De Rango P, Parlani G, Verzini F; Talent Unidoc Retrospective Italian Study (TAURIS) Group. Durability of abdominal aortic endograft with the Talent
Unidoc stent graft in common practice: core lab reanalysis from the TAURIS multicenter study. Journal of Vascular Surgery 2009;49(4):859-865.
42. Holst J, Resch T, Ivancev K, et al. Early and intermediate outcome of emergency endovascular aneurysm repair of ruptured infrarenal aortic aneurysm: a
single-centre experience of 90 consecutive patients. European Journal of Vascular & Endovascular Surgery 2009;37(4):413-419.
43. Brown LC, Greenhalgh RM, Kwong GP, Powell JT, Thompson SG, Wyatt MG ; EVAR Trial Participants. Secondary interventions and mortality following
endovascular aortic aneurysm repair: device-specific results from the UK EVAR Trials. European Journal of Vascular & Endovascular Surgery
2007;34(3):281-290.
44. Hiramoto JS, Reilly LM, Schneider DB, Sivamurthy N, Rapp JH, Chuter TA. Long-term outcome and reintervention after endovascular abdominal aortic
aneurysm repair using the Zenith stent graft. Journal of Vascular Surgery 2007;45(3):461-466.
45. Timaran CH, Lipsitz EC, Veith FJ, et al; Zenith Investigators. Endovascular aortic aneurysm repair with the Zenith endograft in patients with ectatic iliac
arteries. Annals of Vascular Surgery 2005;19(2):161-166.
46. Verhoeven ELG, Tielliu FJ, Prins TR, et al. Frequency and outcome of re-interventions after endovascular repair for abdominal aortic aneurysm: a prospective
cohort study. European Journal of Endovascular Surgery 2004;28(4):357-364.
47. Carroccio A, Faries PL, Morrissey NJ, et al. Predicting iliac limb occlusions after bifurcated aortic stent grafting: anatomic and device-related causes.
Journal of Vascular Surgery 2002;36(4):679-684.
48. F lora HS, Chaloner EJ, Sweeney A, Brookes J, Raphael MJ, Adiseshiah M. Secondary intervention following endovascular repair of abdominal aortic
aneurysm: a single centre experience. European Journal of Vascular & Endovascular Surgery 2003;26(3):287-292.
49. Dias NV, Ivancev K, Malina M, Resch T, Lindblad B, Sonesson B. Does the wide application of endovascular AAA repair affect the results of open surgery?
European Journal of Vascular & Endovascular Surgery 2005;26(2):188-194.
50. Abraham C, Chuter TAM, Reilly LM, et al. Abdominal aortic aneurysm repair with the Zenith stent graft: short to midterm results. Journal of Vascular
Surgery 2002;36(2):217-225.
51. Goodman M, Lawrence-Brown MM, Hartley D, Allen YB, Semmens JB. Treatment of infrarenal abdominal aortic aneurysms with oversized (36-mm) Zenith
endografts. Journal of Endovascular Therapy 2007;14(1):23-29.
52. Stanley BM, Semmens JB, Mai Q, et al. Evaluation of patient selection guidelines for endoluminal AAA repair with the Zenith Stent-Graft: the Australasian
experience. Journal of Endovascular Therapy 2001;8(5):457-464.
53. Alric P, Hinchliffe RJ, MacSweeney STR, Wenham PW, Whitaker SC, Hopkinson BR. The Zenith aortic stent-graft: a 5-year single-center experience. Journal
of Endovascular Therapy 2002;9(6):719-728.
54. Hugl B, Hakaim AG, Biebl M, et al; Zenith Investigators. Impact of gender on the outcome of endovascular aortic aneurysm repair using the Zenith stentgraft:
midterm results. Journal of Endovascular Therapy 2007;14(2):115-121.
55. Pfammatter T, Lachat ML, Künzli A, et al. Short-term results of endovascular AAA repair with the Excluder Bifurcated Stent-Graft. Journal of Endovascular
Therapy 2002;9(4):474-480.
56. Maynar M, Zander T, Qian Z, et al. Bifurcated endoprosthesis for treatment of aortoiliac occlusive lesions. Journal of Endovascular Therapy
2005;12(1):22-27.
57. Shames ML, Sanchez LA, Rubin BG, et al. Delayed complications after endovascular AAA repair in women. Journal of Endovascular Therapy
2003;10(1):10-15.
58. Arko FR, Hill BB, Olcott C, Harris EJ Jr, Fogarty TJ, Zarins CK. Endovascular repair reduces early and late morbidity compared to open surgery for abdominal
aortic aneurysm. Journal of Endovascular Therapy 2002;9(6):711-718.
59. Slovut DP, Ofstein LC, Bacharach JM. Endoluminal AAA repair using intravascular ultrasound for graft planning and deployment: a 2-year community-based
experience. Journal of Endovascular Therapy 2003;10(3):463-475.
60. Ramaiah VG, Westerband A, Thompson C, et al. The AneuRx stent-graft since FDA approval: single-center experience of 230 cases. Journal of Endovascular
Therapy 2002;9(4):464-469.
61. Tonnessen BH, Conners MS III, Sternbergh WC III, Carter G, Yoselevitz M, Money SR. Mid-term results of patients undergoing endovascular aortic aneurysm
repair. American Journal of Surgery 2002;184(6):561-567.
62. Nordness PJ, Carter G, Tonnessen B, Charles Sternbergh W III, Money SR. The effect of gender on early and intermediate results of endovascular aneurysm
repair. Annals of Vascular Surgery 2003;17(6):615-621.
63. Ayerdi J, McLafferty RB, Markwell SJ, et al. Indications and outcomes of AneuRx Phase III trial versus use of commercial AneuRx stent graft. Journal of
Vascular Surgery 2003;37(4):739-743.
64. Zarins CK, Shaver DM, Arko FR, Schubart PJ, Lengle SJ, Dixon SM. Introduction of endovascular aneurysm repair into community practice: initial results with
a new Food and Drug Administration-approved device. Journal of Vascular Surgery 2002;36(2):226-233.
W. L. Gore & Associates, Inc.
Flagstaff, AZ 86004
+65.67332882 (Asia Pacific)
00800.6334.4673 (Europe)
800.437.8181 (United States)
928.779.2771 (United States)
goremedical.com
Products listed may not be available in all markets.
GORE ® , EXCLUDER ® , and designs are trademarks of W. L. GORE & Associates.
© 2010 W. L. GORE & Associates, Inc. AP0692-EN1 AUGUST 2010