W. L. Gore today announced the first implants of its investigational Gore Viafort vascular stent as part of a recently initiated pivotal clinical study for the treatment of inferior vena cava (IVC) occlusive disease with or without iliofemoral vein involvement.
The first patient procedures were completed at the Auckland City Hospital in Auckland, New Zealand, by interventional radiologist Andrew Holden, MD.
“Right now, there are limited device options indicated for both IVC and iliofemoral venous disease,” said Holden. “Implanting the Gore Viafort vascular stent in patients represents a significant step forward in research.”
The stent, which has received Breakthrough Device designation from the Food and Drug Administration (FDA), utilizes expanded polytetrafluoroethylene (ePTFE) technology in conjunction with a single-wound nitinol frame. The Investigational Device Exemption (IDE) study is evaluating the device in a treatment range of 10–28mm diameter for iliofemoral veins and the IVC.