Gore secures FDA clearance for 25cm Viabahn stent graft

6 November 2013 (Last Updated November 6th, 2013 18:30)

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).

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 availability of the longer length 25cm device aligns well with the findings of multiple studies utilising the endoprosthesis, particularly the VIASTAR randomised trial."

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.