Gore Launches VIAFORT Vascular Stent Iliofemoral Pivotal Study
Gore and Associates announced the first U.S. patient has been enrolled in a prospective, non-randomized, multicenter, single-arm, pivotal study to evaluate the VIAFORT vascular stent for the treatment of symptomatic iliofemoral venous obstruction. This device utilizes the Gore expanded polytetrafluoroethylene (ePTFE) technology with a single wire, sinusoidal-wound nitinol frame. The GORE® VIAFORT Vascular Stent Iliofemoral Study is evaluating the device in a treatment range of 10 to 20 mm diameter for iliofemoral veins. The study is being conducted in the U.S. under an approved investigational device exemption (IDE), and involves a maximum of 25 clinical sites across the U.S. with a limit of 33 treated participants per site. A total of 165 participants will be implanted with the GORE® VIAFORT Vascular Stent. Treated participants will be evaluated through hospital discharge and post-treatment visits at 1, 6, 12, 24, 48 and 60 months.
