WL Gore & Associates has received European CE mark approval for the 25cm Viabahn Endoprosthesis with Propaten Bioactive Surface. The new longest length stent-graft available has been designed to cover more of the lesion in the Superficial Femoral Artery (SFA) reducing the need for multiple devices.
The 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 at the proximal end. Removal of excess material at the proximal edge improves device apposition to the vessel wall when oversizing prevents device expansion to its nominal diameter.
Gore said that the device also incorporates the Propaten Bioactive Surface which utilises end-point immobilisation of derivatised heparin to the endoprosthesis luminal surface.
The 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 European Union in December 2008.
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. The Gore Viabahn Endoprosthesis is constructed with a durable, reinforced, biocompatible, ePTFE liner attached to an external nitinol stent structure.
The flexibility of the Gore Viabahn Endoprosthesis enables it to better traverse tortuous areas of the SFA and conform more closely to the complex anatomy of the artery.
Ben Beckstead, product specialist of peripheral vascular business at Gore, said: “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.
“Since the SFA anatomy does vary greatly from case to case, it is important for Gore which has an ongoing commitment to providing physicians with innovative products to be able to provide physicians with the tools and confidence they need to successfully treat their patients.”