W L Gore & Associates (Gore) has received European CE mark approval for the 25cm Gore Viabahn Endoprosthesis with Propaten bioactive surface. The new 25cm Gore Viabahn Endoprosthesis is the longest length stent-graft available, designed to cover more of the lesion in the superficial femoral artery (SFA), potentially reducing the need for multiple devices.
The recently redesigned Gore device features a precision laser trimming technology used to remove excess material, resulting in a contoured proximal edge that may improve flow dynamics and device apposition to the vessel wall when oversizing prevents device expansion to its nominal diameter.
The device also incorporates the Propaten bioactive surface which uses end-point immobilisation of derived heparin to the endoprosthesis luminal surface. This proprietary surface technology preserves the heparin bioactive sites such that they remain free to interact with the blood at the device surface without being consumed. The original Gore Hemobahn Endoprosthesis was introduced to Europe in 1996; the Gore Viabahn Endoprosthesis with Propaten bioactive surface was first approved for use in the EU in December 2008.
“In 1996, the Hemobahn-Viabahn device was the first SFA stent-graft that had good patency rates and it came already in 15cm length,” said Jacques Bleyn, vascular surgeon, Antwerp Blood-Vessel Center, Antwerp, Belgium. “Because long SFA occlusions can be treated endovascularly with the Gore Viabahn device, Gore took the SFA device and made it better: heparin bonded and with a new length of 25cm.”
The Gore Viabahn Endoprosthesis with Propaten bioactive surface is available with a low-profile delivery system that gives interventionalists a more streamlined approach to re-line the peripheral arteries. Its constructed with a durable, reinforced, biocompatible, ePTFE liner attached to an external nitinol stent structure. The excellent flexibility of the endoprosthesis device enables it to better traverse tortuous areas of the SFA and conform more closely to its complex anatomy.
“With all the new advancements to the Gore Viabahn device over the last 12 months, we are pleased to be able to expand this product’s offerings across Europe to include a longer length device,” said Ben Beckstead, product specialist with the Gore Peripheral Vascular Business. “Since the SFA anatomy does vary greatly from case to case, it is important for Goreto be able to provide physicians with the tools and confidence they need to successfully treat their patients.”