WL Gore & Associates has received the US Food and Drug Administration (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.
The device enables a reduction in delivery profile to 6 Fr for 5 and 6mm devices and 7 Fr for 7 and 8mm devices and is delivered over a 0.018" or 0.014" guidewire.
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.
The new device is available with a 120cm long delivery catheter and incorporates the Carmeda BioActive Surface (CBAS), which utilizes end-point immobilization of derivatized heparin to the endoprosthesis luminal surface.
The 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.