CAUTION: Tester. Limited by United States law for investigative purposes.
WL Gore & Associates is initiating its pivotal clinical study of the GORE® VIAFORT device for the treatment of inferior vena cava occlusive disease.
FLAGSTAFF, Ariz., October 28, 2022 /PRNewswire/ — WL Gore & Associates (Gore) today announced the first implants of its investigational product, GORE® VIAFORT Vascular Stent as part of the recently initiated GORE VIAFORT Device Pivotal Clinical Study (ie, prospective, multi-center, non-randomized, single-arm study). NCT05409976) for the treatment of occlusive disease of the inferior vena cava (IVC) with or without involvement of the iliofemoral vein.
The first patient treatments were carried out at Auckland City Hospital in Grafton, Auckland, New Zealandby interventional radiologists Andrew HoldenMD, Director of Regional Interventional Radiology, Auckland Regional Public Health Service.
“This first implantation is an important milestone in the treatment of veno-occlusive disease,” said Dr. Holden. “Currently, there are limited product options indicated for both IVC and iliofemoral vein disease. The implantation of the GORE VIAFORT Vascular Stent in patients is a significant advance in research.”
Designated a Breakthrough Device by the U.S. Food and Drug Administration (FDA), the GORE VIAFORT Vascular Stent utilizes Gore’s proven and durable expanded polytetrafluoroethylene (ePTFE) technology in conjunction with a single-twist nitinol frame. The GORE VIAFORT Device Pivotal Clinical Study is evaluating the device in a 10-28mm diameter treatment area for the iliofemoral veins and inferior vena cava. The study is being conducted in the US under an approved Investigational Device Exemption (IDE).
“We look forward to evaluating the GORE VIAFORT Vascular Stent in patients with IVC occlusive disease,” he said Jill Paine, Head of Peripherals Business at Gore. “At Gore, we strive to build on our legacy of conscious innovation and…
