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GORE ® VIABAHN ® Device for Arteriovenous Access (Revision) Speaker Slideset GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates.

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Presentation on theme: "GORE ® VIABAHN ® Device for Arteriovenous Access (Revision) Speaker Slideset GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates."— Presentation transcript:

1 GORE ® VIABAHN ® Device for Arteriovenous Access (Revision) Speaker Slideset GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.

2 Product Overview Approved in June 2005, the GORE ® VIABAHN ® Endoprosthesis is the only stent-graft available in the US with an SFA, Iliac, and AV Access indication. GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc. The GORE ® VIABAHN ® Endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery de novo and restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 7.5 mm, in superficial femoral artery in-stent restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 6.5 mm, and in iliac artery lesions up to 80 mm in length with reference vessel diameters ranging from 4.0 – 12 mm. The GORE ® VIABAHN ® Endoprosthesis is also indicated for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts. Refer to Instructions for Use at goremedical.com for a complete description of all contraindications, warnings, precautions and adverse events.

3 Restenosis can Occur within Minutes or Hours After a Successful Angioplasty Severe stenosis of cephalic vein Good result immediately after balloon angioplasty Restenosis 30 minutes later due to elastic recoil A C B This study is a representative case. Individual results may vary. GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.

4 Total Endoluminal Bypass: Preventing In-Stent Stenosis The GORE ® VIABAHN ® Endoprosthesis covers and seals off the diseased and irregular tissue of the arterial wall. In contrast, a bare nitinol stent covers only a small portion of the diseased arterial lumen. Individual results may vary. GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.

5 Diffuse In-stent Stenosis is the Common Failure Mode of Bare Metal Stents These studies are representative cases. Individual results may vary. 1 GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.

6 Bare Metal Stent Outcomes Similar to PTA BARD ® and FLAIR ® are trademarks of C. R. Bard, Inc. GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.

7 Flexibility to Conform with the Anatomy These studies are representative cases. Individual results may vary. BARD ® and FLAIR ® are trademarks of C. R. Bard, Inc. GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.

8 These studies are representative cases. Individual results may vary. Flexibility to Conform with the Anatomy BARD ® and FLAIR ® are trademarks of C. R. Bard, Inc. 12. Semin Intervent Radiol. 2011;28(1): GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc. 11. The Gore REVISE Clinical Study Courtesy of William DaVanzo, MD

9 Durability to Last Under Mechanical Strain No reported fractures in the 24-month study period in Gore REVISE Clinical Study. GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc. These studies are representative cases. Individual results may vary.

10 Durability to Last Under Mechanical Strain No reported fractures in the 24-month study period in Gore REVISE Clinical Study. GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc. These studies are representative cases. Individual results may vary.

11 The Gore REVISE Clinical Study The Gore REVISE Clinical Study was a multicenter, randomized-controlled trial evaluating the safety and effectiveness of the GORE ® VIABAHN ® Endoprosthesis in treating stenosis or thrombotic occlusions of a synthetic arteriovenous (AV) access graft at the venous anastomosis. GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc. GORE ® VIABAHN ® Endoprosthesis versus Angioplasty

12 Definitions Target Lesion Primary Patency: The time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion. Circuit Primary Patency: The time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit. Access Secondary Patency: The time interval from initial study treatment to abandonment of the vascular access circuit. The Gore REVISE Clinical Study GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.

13 The Gore REVISE Clinical Study GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.

14 The Gore REVISE Clinical Study GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.

15 The Gore REVISE Clinical Study Primary Safety Endpoint Freedom from major device, procedure, and treatment site-related adverse events through 30 days post-procedure (was met p < ). GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.

16 Primary Effectiveness Endpoint: The GORE ® VIABAHN ® Device group demonstrated statistical superiority over the PTA group in target lesion primary patency as determined by Kaplan-Meier estimates (p = 0.008). The Gore REVISE Clinical Study GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.

17 Greater patency for both thrombotic and non-thrombotic patients The Gore REVISE Clinical Study Despite the reduced patency outcomes for thrombotic patients, no statistical difference was detected in terms of treatment effect of the GORE ® VIABAHN ® Device relative to PTA (p = 0.792). GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.

18 Exceeded KDOQI Expectations in Thrombosis Patients KDOQI Guideline 6.8.2: Circuit Primary Patency > 40% at three months The Gore REVISE Clinical Study GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.

19 The Gore REVISE Clinical Study GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.

20 The Gore REVISE Clinical Study GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc. Stents / stent-grafts were necessary to produce the secondary patency outcomes of the PTA group.

21 Mean Cumulative Interventions per Subject over 24 Months The Gore REVISE Clinical Study Reduced interventions per subject GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.

22 Prior interventions did not affect outcomes for GORE ® VIABAHN ® Device group, but did for the PTA group. The Gore REVISE Clinical Study GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.

23 Flaring not necessary for quality outcomes The Gore REVISE Clinical Study GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.

24 Comparison of the Gore REVISE Clinical Study to the Bard FLAIR Pivotal Study Gore REVISE Clinical Study included, but the Bard FLAIR Pivotal Study excluded: Stenosis > 7 cm from anastomosis Thrombosis patients (43% of subjects) Crossing the elbow and angles > 90 o Conclusions from comparisons of different clinical studies should be made with caution as the poolability of the different subject cohorts was not determined statistically GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc.

25 References 1. Yoon YC, Shin BS, Ahn M, Park MH, Ohm JY, Kim HJ. Comparison of a nitinol stent versus balloon angioplasty for treatment of a dysfunctional arteriovenous graft. Journal of the Korean Society of Radiology 2012;66(6): Vogel PM, Parise C. SMART stent for salvage of hemodialysis access grafts. Journal of Vascular & Interventional Radiology 2004;15(10): Vogel PM, Parise C. Comparison of SMART stent placement for arteriovenous graft salvage versus successful graft PTA. Journal of Vascular & Interventional Radiology 2005;16(12): Liang HL, Pan HB, Lin YH, et al. Metallic stent placement in hemodialysis graft patients after insufficient balloon dilation. Korean Journal of Radiology 2006;7(2): Maya ID, Allon M. Outcomes of thrombosed arteriovenous grafts: comparison of stents vs angioplasty. Kidney International 2006;69(5): Chan MR, Bedi RJ, et al. Stent placement versus angioplasty improves patency of arteriovenous grafts and blood flow of arteriovenous fistulae. Clinical Journal of the American Society of Nephrology 2008;3(3): Hatakeyama S, Toikawa T, Okamoto A, et al. Efficacy of SMART stent placement for salvage antioplasty in hemodialysis patients with recurrent vascular access stenosis. International Journal of Nephrology 2011;2011: Kim CY, Tandberg DJ, Rosenberg MD, Miller MJ, Suhocki PV, Smith TP. Outcomes of prosthetic hemodialysis grafts after deployment of bare metal versus covered stents at the venous anastomosis. Cardiovascular & Interventional Radiology 2012;35(4): Vesely TM, Siegel JB. Use of the peripheral cutting balloon to treat hemodialysis-related stenoses. Journal of Vascular & Interventional Radiology 2005;16(12): Haskal ZJ, Trerotola S, Dolmatch B, et al. Stent graft versus balloon angioplasty for failing dialysis-access grafts. New England Journal of Medicine 2010;362(6): W. L. Gore & Associates, Inc. GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis (REVISE). ClinicalTrials.gov. Bethesda, MD: National Library of Medicine; Published August 15, Updated January 23, Accessed October 8, NLM Identifier: NCT Funaki B, Slaby J. Covered stent compression in dialysis access. Seminars in Interventional Radiology 2011;28(1):

26 Products listed may not be available in all markets. BARD ® and FLAIR ® are trademarks of C. R. Bard, Inc. GORE ®, VIABAHN ®, and designs are trademarks of W. L. Gore & Associates. © 2014 W. L. Gore & Associates, Inc. AT0713-EN2 NOVEMBER 2014 INTENDED USE / INDICATIONS: The GORE ® VIABAHN ® Endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery de novo and restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 7.5 mm, in superficial femoral artery in-stent restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 6.5 mm, and in iliac artery lesions up to 80 mm in length with reference vessel diameters ranging from 4.0 – 12 mm. The GORE ® VIABAHN ® Endoprosthesis is also indicated for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts. Refer to Instructions for Use at goremedical.com for a complete description of all contraindications, warnings, precautions and adverse events.


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