The Continuing Evolution of a Revolutionary Device

With FDA approval for the treatment of in-stent restenosis (ISR) in the SFA, the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface delivers.

Clinically Demonstrated Performance in ISR

  • Multicenter randomized trial comparing the performance of the GORE® VIABAHN® Endoprosthesis with PTA in treatment of in-stent restenosis of the SFA.
  • Subjects in the GORE® VIABAHN® Endoprosthesis arm of the RELINE trial were approximately three times less likely than those in the PTA arm to require a target lesion revascularization (TLR) at one year1.

Complete Coverage

  • 25 cm length
  • CBAS Heparin Surface
  • Expanded PTFE (ePTFE) liner
  • Long-lasting solution

Enhanced Visibility

  • Addition of four gold radiopaque markers bonded to the graft at the end of endoprosthesis

Reliable Performance

  • More vascular indications supported by more level 1 clinical trials than any other self-expanding peripheral stent or stent-graft*

RELINE Clinical Study Conclusions

  • Evidence from the RELINE trial support the safety and effectiveness of the GORE® VIABAHN® Endoprosthesis in relining failed bare metal stents.
  • Superior primary patency at one-year in the GORE® VIABAHN® Endoprosthesis group in the per-protocol analysis.
  • Subjects in the GORE® VIABAHN® Endoprosthesis arm were approximately three times less likely to require a TLR.
  • Freedom from serious device-related adverse events similar in both arms of the study.
  1. Deloose K. RELINE - randomized clinical trial: Viabahn covered stents vs. PTA. Presented at The Leipzig Interventional Course - LINC 2014; January 28-31, 2014; Leipzig, Germany.

Decades of Design

GORE VIABAHN Endoprosthesis

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