FDA Approves Next-Generation Gore Viabahn

February 17, 2011—Gore & Associates (Flagstaff, AZ) announced that it has received US Food and Drug Administration approval for the Gore Viabahn endoprosthesis with heparin bioactive surface on a lower-profile delivery system.

According to the company, the Viabahn 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 F for 5- and 6-mm devices and 7 F for 7- and 8-mm devices. It is delivered over a 0.018- or 0.014-inch guidewire. No changes have been made to the endoprosthesis. The reduced delivery profile will provide more options for delivery 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,” commented Gary Ansel, MD.

The Gore Viabahn endoprosthesis with heparin bioactive surface is approved for use in the SFA and iliac artery. The new device is available with a 120-cm-long delivery catheter and incorporates the company's Carmeda bioactive surface, which utilizes endpoint immobilization of derivatized heparin to the endoprosthesis luminal surface. The Carmeda technology preserves the heparin bioactive sites so that they remain free to interact with the blood at the device surface without being consumed.

The stent graft is constructed with a reinforced, biocompatible, expanded polytetrafluoroethylene liner attached to an external nitinol stent structure. Gore stated that the device's flexibility enables it to traverse tortuous areas of the SFA and iliac artery, allowing it to conform to these arteries and withstand complex mechanical motion. In the United States, the Viabahn was introduced in 2001, and the Viabahn with heparin bioactive surface was approved for use in 2007.