FDA approves GORE VIABAHN device to treat peripheral artery disease

W. L. Gore & Associates (Gore) today announced it has received FDA approval for the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface on a lower profile delivery system. The GORE VIABAHN Device is designed to percutaneously treat peripheral artery disease by relining the native vessel. This next generation device enables a reduction in delivery profile to 6 Fr for 5 and 6 mm devices and 7 Fr for 7 and 8 mm devices and is delivered over a 0.018" or 0.014" guidewire. No changes have been made to the endoprosthesis. The reduced delivery profile will provide interventionalists with greater options for delivery with the same trackability and device performance in treating stenoses and occlusions of the Superficial Femoral Artery (SFA) and Iliac Artery.

"While most technology has stagnated over the past several years, W. L. Gore continues to optimize the GORE VIABAHN Endoprosthesis which allows physicians to broaden the potential patient population that we can treat," said Gary Ansel, MD, Interventional Cardiologist at Riverside Methodist Hospital, Columbus, Ohio.

The GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface is the only stent-graft approved for use in the SFA and Iliac artery. The new device is available with a 120 cm long delivery catheter and incorporates the Carmeda® BioActive Surface (CBAS®), which utilizes end-point immobilization of derivatized heparin to the endoprosthesis luminal surface. This proprietary CBAS 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 GORE VIABAHN Endoprosthesis was introduced in the US in 2001. The GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface was approved for use in the US in 2007. The stent-graft 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 Iliac artery allowing it to conform to these arteries and withstand complex mechanical motion.

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