Gore touts Viabahn endoprosthesis superiority over PTA in new study

W.L. Gore & Associates today released results from a clinical study of its Viabahn endoprosthesis in AV access graft outflow interventions, touting a 50% increase over percutaneous transluminal angioplasty alone in target lesion primary patency at 6 months.

The company reported that treatment with the Viabahn resulted in significantly better outcomes when compared against PTA alone for treating challenging AV access cases, both in terms of primary patency and number of interventions during the study period.

Results from the study were published in the Journal of Vascular Surgery, Newark, Del.-based Gore said.

“Patients with failing dialysis circuits that are unresponsive to balloon angioplasty are a real problem for physicians. Historically, angioplasty has been a popular treatment option, but our study found its 6-month primary patency rates to be well below the ‘reasonable goal’ of 50% stated by the 2006 K/DOQI Guidelines for Vascular Access. The data shown in the Gore Revise clinical study manuscript makes a compelling argument for Gore Viabahn Endoprosthesis use in those challenging cases,” primary author Dr. Thomas Vesely of St. Louis, Mo.’s Vascular Access Services said in a prepared statement.

Data from the study also indicated a 47% improvement in target lesion primary patency and a 48% improvement in circuit primary patency when compared against PTA alone at 6 months. In elbow placements, data indicated a 72% target lesion primary patency at 6 months and 83% access secondary patency at 24 months.

Median time to target lesion reintervention or graft abandonment with the Viabahn was reportedly 2 times that of PTA alone, and placement of the Viabahn led to 27% fewer interventions at the target lesion and in the dialysis access circuit over 2-years, when compared to PTA.

“The Gore Revise clinical study was the clinical support used to gain the U.S. on-label indication for Gore Viabahn endoprosthesis in AV access. By expanding indications to include AV access, Gore Viabahn endoprosthesis continues to show how physicians can depend on the device for complete coverage in complex cases,” Gore peripheral interventional biz leader Ray Swinney said in a press release.

Last December, Gore said it launched a post-approval study of its Viabahn stent graft. The 108-patient Reline Max study will examine the treatment of in-stent restenosis in the superficial femoral artery using the Viabahn device, which is designed to inhibit blood clots with its heparin coating.

The Viabahn stent graft, which 1st won FDA approval in 2005, was approved by the safety watchdog for treating in-stent restenosis last year.

The Reline Max trial’s primary safety endpoint is procedure- and device-related serious adverse events at 30 days, according to ClinicalTrials.gov, and the primary efficacy endpoint is primary patency without repeat intervention after a year. The trial, estimated to be complete in November 2020, is slated for final data collection in November 2018.

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