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
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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
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25 cm length
CBAS Heparin Surface
Expanded PTFE (ePTFE) liner
Long-lasting solution
Enhanced Visibility
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Addition of four gold radiopaque markers bonded to the graft at the end of endoprosthesis
Reliable Performance
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More vascular indications supported by more level 1 clinical trials than any other self-expanding peripheral stent or stent-graft*
RELINE Clinical Study Conclusions
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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.
- 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.