News | July 6, 2010

Gore Receives CE Mark For Longer Length GORE VIABAHN Endoprosthesis

Longest Stent-Graft Ever Introduced in Europe for SFA Endoluminal Bypass

Flagstaff, AZ - W. L. Gore & Associates (Gore) today announced that it has received European CE Mark approval for the 25 cm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface. The new 25 cm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface 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 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. The device also incorporates the PROPATEN Bioactive Surface which utilizes end-point immobilization of derivatized 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 European Union in December 2008.

"In 1996, the [GORE] HEMOBAHN-VIABAHN device was the first SFA stent-graft that had good patency rates and it came already in 15 cm length," said Jacques Bleyn, MD, Vascular Surgeon, Antwerp Blood-Vessel Center, Antwerp, Belgium. "Because long SFA occlusions can be treated endovascularly with the GORE VIABAHN device, Gore took this best SFA device and made it better: heparin bonded and a new length of 25 cm."

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 excellent 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.

"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, PhD, Product Specialist with the Gore Peripheral Vascular Business. "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."

SOURCE: W. L. Gore & Associates