FDA Approves 25-cm Gore Viabahn Endoprosthesis to Treat Long-Segment SFA Lesions

November 6, 2013—Gore & Associates (Flagstaff, AZ) announced 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 designed to cover long-segment lesions in the SFA, potentially reducing the need for multiple devices.

The stent graft design of the Gore Viabahn endoprosthesis with heparin bioactive surface consists of a durable, reinforced, biocompatible, expanded-polytetrafluoroethylene 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-inch or 0.018-inch/0.014-inch wire platforms. The heparin bioactive surface utilizes the company's endpoint covalent immobilization of heparin to the surface of the endoprosthesis. This surface technology is intended to provide a thromboresistant surface through sustained heparin bioactivity.

According to the company, 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% had total occlusions of the SFA. One-year data demonstrated a freedom from target lesion revascularization of 78.2%. In addition, the Gore Viabahn device exhibited no fractures at 12 months.

In October, the VIASTAR trial was published by Johannes Lammer, MD, et al in the Journal of the American College of Cardiology (2013;62:1320–1327).

According to the company, VIASTAR compared the performance of the Gore Viabahn device in long-segment SFA disease 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% and 70% chronic total occlusions in each arm, respectively. The primary patency rate at 1 year was 78% for the Gore Viabahn device and 54% for bare-metal stents. In lesions that were at least 20 cm in length, the patency rate was 73% in the Gore Viabahn device arm and 33% in the bare-metal stent arm, reported the company.

Gore stated that the 25-cm study results supplement data from a physician-sponsored investigational device exemption trial conducted previously. Dennis Gable, MD, a vascular surgeon at The Heart Hospital Baylor Plano in Plano, Texas, discussed this trial in the company's press release.

Dr. Gable commented, “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. Our results demonstrated no difference in primary patency or limb salvage out to 4 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.”