W L Gore & Associates (Gore) has obtained US Food and Drug Administration (FDA) approval for its 25cm Viabahn endoprosthesis, which is treated with a heparin bio-active coating, for treating symptomatic peripheral arterial disease lesions in the superficial femoral artery (SFA).
The device is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner attached to an external nitinol stent structure that acts as a barrier to in-stent restenosis.
The stent-graft features the addition of proprietary heparin-bonded technology to the proven combination of ePTFE and nitinol.
This proprietary surface technology is intended to provide a thromboresistant surface through sustained heparin bioactivity.
It has been described as the longest length stent-graft available in the market and is designed to cover long-segment lesions in the SFA, potentially reducing the need for multiple devices.
The device is available in configurations that are compatible with 0.035in or 0.018/0.014in wire platforms.
The FDA approval of the 25cm device was obtained based on the positive results from a multicentre European trial.
One-year data reported a freedom from target lesion revascularisation of 78.2% and the device also exhibited zero fractures at 12 months.
The 25cm study results supplement data from a physician-sponsored investigational device exemption (IDE) trial conducted previously.
Gore peripheral interventional business leader Ben Beckstead said: "The availability of the longer length 25cm device aligns well with the findings of multiple studies utilising the endoprosthesis, particularly the VIASTAR randomised trial."
The VIASTAR trial is a European-based randomised study of Viabahn versus bare-nitinol stent placement.
In the recently published 12-month results from this study, the primary patency rate at one year was 78% for the Gore Viabahn device and 54% for bare metal stents.
The mean lesion length was 19cm in the Gore Viabahn device arm and 17.3cm in the bare metal stent arm, with 79% and 70% chronic total occlusions in each arm, respectively.
In lesions that were at least 20cm in length, the patency rate was 73% in the Gore Viabahn device arm and 33% in the bare metal stent arm.
According to GlobalData estimates, the US stent grafts market was valued at $747m in 2012 and is expected to grow at a CAGR of 4.2% to reach $993m by 2019.