W. L. Gore & Associates (Gore) has obtained an approval from the US Food and Drug Administration (FDA) for its 25cm GORE VIABAHN endoprosthesis with heparin bioactive surface.
The 25cm Gore Viabahn endoprosthesis is intended to treat symptomatic peripheral arterial disease lesions in the superficial femoral artery (SFA).
The FDA has approved the device based on the positive outcome from a one-year, multicenter, European trial.
In the 12-month clinical trial, the Gore Viabahn device showed no fractures and demonstrated a freedom from target lesion revascularization of 78.2%.
The device has been constructed with a biocompatible polytetrafluoroethylene (ePTFE) liner attached to an external nitinol stent structure that acts as a barrier to in-stent restenosis.
It incorporates the heparin bioactive surface that uses an end-point covalent immobilization of heparin to the surface of the endoprosthesis.
This surface technology provides a thromboresistant surface through sustained heparin bioactivity.
Gore's 25cm endoprosthesis device covers long-segment lesions in the SFA and potentially reduces the need for multiple devices.
The company claims it is the only longest length stent-graft available in the market.
Gore peripheral interventional business leader Ben Beckstead noted the Gore Viabahn endoprosthesis is the only device of its kind approved for both the SFA and iliac artery.
"The availability of the longer length 25 cm device aligns well with the findings of multiple studies utilizing the endoprosthesis, particularly the Viastar randomized trial," Beckstead added.
The 25cm endoprosthesis device is available in configurations that are compatible with 0.035" or 0.018/0.014" wire platforms.
