New GORE VIABAHN Endoprosthesis is now available in Europe

W. L. Gore & Associates (Gore) today announced the European availability of the GORE® VIABAHN® Endoprosthesis on a lower profile delivery system. The announcement came during the Leipzig Interventional Course in Germany, where European interventionalists gathered to discuss new approaches in treating patients suffering from peripheral artery disease (PAD). The new GORE VIABAHN lower profile delivery system received CE Mark approval in late 2010.

The GORE VIABAHN Device is designed to percutaneously treat peripheral artery disease by relining the native vessel. This next generation stent-graft enables a reduction in delivery profile to 6 French (Fr) for 5 and 6 mm devices and 7 Fr for 7 and 8 mm devices and is delivered over a 0.18" or 0.14" guidewire. The reduced delivery profile will provide interventionalists with greater options for delivery with the same trackability and device performance in treating stenosis and occlusions of the Superficial Femoral Artery (SFA) and other peripheral arteries where a small access size is critical.

The GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface is the only device of its kind in Europe, approved for endovascular grafting of peripheral arteries. The new GORE VIABAHN Device delivery catheter is available in a 120 cm length and 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.

"A reduction in profile seen in the GORE VIABAHN Endoprosthesis means easier endovascular delivery of the device to treat occlusions in the superficial femoral artery (SFA) and other tough to reach locations in patients where a small access size is critical and includes all of the historical benefits of heparin-bonded PROPATEN Bioactive Surface," said Dr. Daniele Savio, MD, Vascular and Interventional Radiology, San Giovanni Bosco Hospital, Torino, Italy.

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 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 peripheral arteries and conforms to these arteries and withstands complex mechanical motion.

"With all the new advancements to the GORE VIABAHN Device over the last 15 years, we are pleased to be able to expand our offering across Europe, once again, with the launch of this new profile," said Erin Hutchinson, associate with the Gore Peripheral Vascular Business. "As every clinical case is different, Gore is committed to providing physicians globally with innovative tools to successfully treat their patients."