FDA approves endovascular treatment of in-stent restenosis with Viabahn endoprosthesis


W L Gore & Associates has announced that the Food and Drug Administration (FDA) has approved the Viabahn endoprosthesis for interventional treatment of in-stent restenosis in the superficial femoral artery (SFA). Now indicated for the treatment of failed bare metal stents in the superficial femoral artery, the Viabahn device has more vascular indications supported by more level 1 clinical trials than any other self-expanding peripheral stent or stent-graft.

In-stent restenosis or reocclusion occurs in a significant number of patients over the course of one year after bare metal stenting, and these rates are highly dependent on the severity of disease. Treatment options for in-stent restenosis include angioplasty, repeat stenting with another bare metal stent, and surgical bypass. The Viabahn device changes the current treatment paradigm for in-stent restenosis by re-lining the failed bare metal stent and adjacent diseased vessel, providing a long-term physical barrier that extends the life of the intervention.

The safety and efficacy of the Viabahn device in this indication was supported by the randomised RELINE clinical study, in which the lesions in both arms of the study averaged more than 17cm in length. The study found that the device is statistically superior in target lesion primary patency than percutaneous transluminal angioplasty, which is the most common frontline interventional treatment of in-stent restenosis.

The RELINE clinical study found that:

  • Subjects in the Viabahn device arm of the RELINE trial were approximately three times less likely than those in the percutaneous transluminal angioplasty arm to require a target lesion revascularisation (TLR) after one year.
  • After 12 months, the Viabahn endoprosthesis showed a primary patency of 74.8%, more than 45% higher than percutaneous transluminal angioplasty.
  • With the longest available 25cm stent-graft, heparin surface, and ePTFE liner, the Viabahn device is a long-lasting solution for treatment of failed bare stents.

“The treatment of failed bare metal stents has long been a perplexing problem for vascular specialists, in which only a few treatments are FDA-approved and limited compelling clinical data exist. This new indication for the Gore device and the accompanying data from the RELINE trial provide physicians with the means to intervene confidently on a failed bare metal stent, extending the life of the intervention and improving patient outcomes,” says Peter A Soukas, assistant professor of Medicine, Brown Medical School.