FLAGSTAFF, Ariz.--(BUSINESS WIRE)--W. L. Gore & Associates (Gore) today reported the first European clinical use of the GORE® VIABAHN® Endoprosthesis with PROPATEN 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 first European procedures to treat a patient using the device were performed by Enrico Vecchiati, MD, Vascular Surgery, A.O. Santa Maria Nuova Hospital, Reggio Emilia, Italy.
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. 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 other peripheral arteries where a small access size is critical. The device received CE Mark approval in late 2010 and FDA approval in February of 2011.
“In our early experience, we had the opportunity to use the GORE VIABAHN Endoprosthesis (6 mm x 25 cm) with the lower 6 Fr profile. This reduction of profile is opening new opportunities to treat patients where a small access site is critical. If we consider that the product includes the heparin-bonded surface, we can expect greater patient outcomes combined with easy endovascular approach and delivery. This is the perfect combination to treat occlusions in the SFA and Popliteal Artery Aneurysm (PAA),” said Dr. Vecchiati.
The GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface is the only device of its kind in Europe, approved for endovascular grafting of peripheral arteries. 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 peripheral arteries, 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 www.goremedical.com.
Products listed may not be available in all markets. GORE®, PROPATEN, 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.