W L Gore & Associates (Gore) today announced the first implants of its investigational Gore Viafort vascular stent as part of the recently initiated Gore Viafort device pivotal clinical study for the treatment of inferior vena cava (IVC) occlusive disease with or without iliofemoral vein involvement.
The first patient procedure was completed at the Auckland City Hospital in Auckland, New Zealand, by interventional radiologist Andrew Holden.
“This first implantation is an important milestone for venous occlusive disease treatment,” Holden said. “Right now, there are limited device options indicated for both IVC and iliofemoral venous disease. Implanting the Gore Viafort vascular stent in patients represents a significant step forward in research.”
A company press release notes that the Gore Viafort vascular stent, which has received Breakthrough Device designation from the US Food and Drug Administration (FDA), utilises Gore’s expanded polytetrafluoroethylene (ePTFE) technology in conjunction with a single-wound nitinol frame. The Gore Viafort device pivotal clinical study is evaluating the device in a treatment range of 10–28mm diameter for iliofemoral veins and the IVC. The study is being conducted in the USA under an approved investigational device exemption (IDE).
“We are excited to explore the Gore Viafort vascular stent in people experiencing IVC occlusive disease,” said Jill Paine, Peripheral business leader at Gore. “At Gore, we strive to build on our legacy of deliberate innovation and prioritize research that addresses unmet needs so we truly can help improve life.”