GORE® VIABAHN® Endoprosthesis

GORE® VIABAHN® Endoprosthesis

Proven patency<br>Demonstrated durability<br>Fewer reinterventions<br>Broadly indicated

Proven patency 

1. Ohki T, Kichikawa K, Yokoi H, et al. Outcomes of the Japanese multicenter Viabahn trial of endovascular stent grafting for superficial femoral artery lesions. Journal of Vascular Surgery 2017;66(1):130-142.e1. 

2. Lammer J, Zeller T, Hausegger KA, et al. Sustained benefit at 2 years for covered stents versus bare-metal stents in long SFA lesions: the VIASTAR Trial. Cardiovascular & Interventional Radiology 2015;38(1):25-32. 

3. Zeller T, Peeters P, Bosiers M, et al. Heparin-bonded stent-graft for the treatment of TASC II C and D femoropopliteal lesions: the Viabahn-25 cm Trial. Journal of Endovascular Therapy 2014;21(6):765-774. 

4. Reijnen M, van Walraven L, Fritschy W, et al. 1-year results of a multicenter, randomized controlled trial comparing heparin-bonded endoluminal to femoropopliteal bypass. Journal of Cardiovascular Interventions 2107;10(22):2320-2331. 

5. Saxon RR, Chervu A, Jones PA, et al. Heparin bonded, expanded polytetrafluoroethylene lined stent graft in the treatment of femoropopliteal artery disease: 1 year results of the VIPER (Viabahn Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease) Trial. Journal of Vascular & Interventional Radiology 2013;24(2):165 173.

6. Yamaoka T.  VIABAHN the latest real world clinical data from Japan to the worlds PMS 1Y/IDE 5Y VIABAHN.  Presented at JETTALKS on Air.  April 18-19, 25-26, 2020.  Accessed March 2, 2021.  http://www.j-et.jp/jet2020/jettalks/JETTALKS_Final_Program_Day2.pdf

7. Bosiers M, Deloose K, Callaert J, et al. Superiority of stent grafts for in stent restenosis in the superficial femoral artery: twelve month results from a multicenter randomized trial. Journal of Endovascular Therapy 2015;22(1):1-10.

8. Vesely T, DaVanzo W, Behrend T, Dwyer A, Aruny J. Balloon angioplasty versus Viabahn stent graft for treatment of failing or thrombosed prosthetic hemodialysis grafts. Journal of Vascular Surgery 2016;64(5):1400-1410.e1. 

9. Lammer J, Dake MD, Bleyn J, et al. Peripheral arterial obstruction: prospective study of treatment with a transluminally placed self expanding stent graft. Radiology 2000;217(1):95-104.

Demonstrated durability

10. Iida O. Update on value and indications of the Viabahn self-expanding stent-graft for fempop occlusive disease: evolution of the device: technical tips and 5-year results from Japan. Presented at the 46th Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (VEITHsymposium); November 19 -23, 2019; New York, NY.

11. Bosiers M, Deloose K. 2-year results of the RELINE Trial comparing Viabahn Stent-Grafts to POBA for ISR show durable benefits to endograft treatment. Presented at the 41st Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (VEITHsymposium); November 18-22, 2014; New York, NY. Abstract 168.

12. McQuade K, Gable D, Pearl G, Theune B, Black S.  Four year randomized prospective comparison of percutaneous ePTFE/ nitinol self expanding stent graft versus prosthetic femoral popliteal bypass in the treatment of superficial femoral artery occlusive disease.  Journal of Vascular Surgery 2010;52(3):584 591.

13. Reijnen M, van Walraven L, Fritschy W, et al.  1-year results of a multicenter, randomized controlled trial comparing heparin-bonded endoluminal to femoropopliteal bypass.  Journal of Cardiovascular Interventions 2017;10(22):2320-2331.

14. GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface Instructions for Use (IFU).  W. L. Gore & Associates, Inc website.  March 3, 2021  https://eifu.goremedical.com/

Fewer reinterventions

15. Mohr BA, Sheen AL, Roy-Chaudhury P, Schultz SR, Aruny JE; REVISE Investigators. Clinical and economic benefits of stent grafts in dysfunctional and thrombosed hemodialysis access graft circuits in the REVISE Randomized Trial. Journal of Vascular & Interventional Radiology 2019;30(2):203-211.e4. https://www.jvir.org/article/S1051-0443(18)31772-X/fulltext

16. GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface Instructions for Use (IFU).  W. L. Gore & Associates, Inc website.  March 3, 2021  https://eifu.goremedical.com/

Broadly indicated

17. GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface Instructions for Use (IFU).  W. L. Gore & Associates, Inc website.  March 3, 2021  https://eifu.goremedical.com/

Instructions for Use

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