Flagstaff, Ariz. (November 6, 2013) — W. L. Gore & Associates (Gore) announced today that the US Food and Drug Administration (FDA) has approved the 25 cm GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface for the treatment of symptomatic peripheral arterial disease lesions in the Superficial Femoral Artery (SFA). The new 25 cm endoprosthesis is the longest length stent-graft available, and is designed to cover long-segment lesions in the SFA, potentially reducing the need for multiple devices.
The FDA approval of the 25 cm device was supported by evidence from a multicenter European trial. Patients enrolled in the study had lesion lengths ranging from 20 cm to 40 cm, with a mean length of 26.5 cm. Of all patients enrolled, 92.9 percent had total occlusions of the SFA. One-year data demonstrated a freedom from target lesion revascularization of 78.2 percent. In addition, the GORE® VIABAHN® Device exhibited no fractures at 12 months.
The 25 cm study results supplement data from a physician-sponsored investigational device exemption (IDE) trial conducted previously. “We have been awaiting the approval of the 25 cm [GORE® VIABAHN® Device] since our study directly comparing the [GORE® VIABAHN®] Stent-graft as an endoluminal bypass in the SFA to open femoral popliteal bypass of the SFA was completed,” said Dennis Gable, MD, vascular surgeon at The Heart Hospital Baylor Plano in Plano, Texas. “Our results demonstrated no difference in primary patency or limb salvage out to four years when comparing the two treatment modalities—even with a mean stented length of 25.6 cm in the [GORE® VIABAHN® Device] arm. Our study results are supported by the similar outcomes of the European data and show that treatment of truly long lesions can now successfully be accomplished with only one stent device with excellent results; a true advance for patients in the treatment of SFA disease.”
The unique stent-graft design of the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface consists of a durable, reinforced, biocompatible, ePTFE liner attached to an external nitinol stent structure that acts as a barrier to in-stent restenosis. The device is available in configurations that are compatible with 0.035” or 0.018/0.014” wire platforms. The device also incorporates the Heparin Bioactive Surface, which utilizes a proprietary end-point covalent immobilization of heparin to the surface of the endoprosthesis. This proprietary surface technology is intended to provide a thromboresistant surface through sustained heparin bioactivity.
“The GORE® VIABAHN® Endoprosthesis is the only device of its kind approved for both the SFA and iliac artery. The availability of the longer length 25 cm device aligns well with the findings of multiple studies utilizing the endoprosthesis, particularly the VIASTAR randomized trial” said Ben Beckstead, Gore Peripheral Interventional Business Leader.
In the recently published VIASTAR Trial, the performance of the GORE® VIABAHN® Device in long-segment SFA disease was compared to that of bare metal stents in a randomized head-to-head fashion. The mean lesion length was 19 cm in the GORE® VIABAHN® Device arm and 17.3 cm in the bare metal stent arm, with 79 percent and 70 percent chronic total occlusions in each arm, respectively. The primary patency rate at one year was 78 percent for the GORE® VIABAHN® Device and 54 percent for bare metal stents. In lesions that were at least 20 cm in length, the patency rate was 73 percent in the GORE® VIABAHN® Device arm and 33 percent in the bare metal stent arm.
ABOUT W. L. GORE & ASSOCIATES
The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for more than 35 years. During that time, more than 35 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 is one of a select few companies to appear on all of the U.S. “100 Best Companies to Work For” lists since the rankings debuted in 1984.