Gore Reports First Patient Treated in the U.S. using GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface on a Lower Profile Delivery System
Lower Profile Delivery System Provides More Options for Endoluminal Bypass
Flagstaff, AZ (March 21, 2011)—W. L. Gore & Associates (Gore) today reported the first clinical use in the US of the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface on a lower profile delivery system. The GORE VIABAHN Device is designed to percutaneously treat SFA and iliac peripheral artery disease by relining the native vessel. The first US 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 Superficial Femoral Artery (SFA) and Iliac Artery. The lower profile device was approved by the FDA 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.
About W. L. Gore & Associates
The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 30 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, soft tissue reconstruction, staple line reinforcement and sutures for use in vascular, cardiac and general surgery. Gore was recently named one of the best companies to work for by FORTUNE magazine for the 14th consecutive year. For more information, visit goremedical.com
Products listed may not be available in all markets. GORE®, VIABAHN®, and designs are trademarks of W. L. Gore & Associates. CARMEDA® and CBAS® are trademarks of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates.
Erik Clausen or Kena Hudson
Chempetitive Group for W.L. Gore & Associates