First clinical use of GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface on lower profile delivery system

W. L. Gore & Associates (Gore) today reported the first clinical use in the U.S. of the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface on a lower profile delivery system. The GORE VIABAHN Device is designed to percutaneously treat Superficial Femoral Artery (SFA) and iliac peripheral artery disease by relining the native vessel. The first U.S. procedure to treat a patient using the device was performed by Tony Das, MD, Director of Peripheral Interventions at Texas Health Presbyterian Hospital Dallas in Dallas, Texas.

The GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface is a next generation device that 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. The reduced delivery profile provides interventionalists with greater options for delivery with the same trackability and device performance in treating stenoses and occlusions of the SFA and Iliac artery. The FDA approved the lower profile device in February 2011.

"The use of covered stents to treat vascular disease has been limited in some patients due to the need for a larger sheath size. That gap between covered stents and bare metal stents has now been bridged. The reduction in French size of the GORE VIABAHN Endoprosthesis is a revolutionary advancement giving physicians more options in the treatment of peripheral vascular disease," commented Dr. Das.

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® Surface), which utilizes end-point immobilization of derivatized heparin to the luminal surface of the endoprosthesis. 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 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.