The device is intended to treat inferior vena cava occlusive disease.
WL Gore & Associates (Gore) has announced the first Gore Viafort Vascular Stent implants in patients at Auckland City Hospital, New Zealand.
The implant procedures were performed by Auckland Regional Public Health Service Regional Interventional Radiology director Dr Andrew Holden and completed as part of the multicentre and non-randomised single-arm Gore Viafort Device Pivotal Clinical Study.
The vascular stent is intended to treat inferior vena cava (IVC) occlusive disease with or without the involvement of the iliofemoral vein.
Holden said: “This first implantation is an important milestone for venous occlusive disease treatment.
“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.”
The US Food and Drug Administration (FDA) previously granted Breakthrough Device designation for the vascular stent, which uses Gore’s expanded polytetrafluoroethylene (ePTFE) technology as well as a single-wound nitinol frame.
A clinical study assessing the stent in a treatment range of 10mm to 28mm diameter for iliofemoral veins and inferior vena cava is currently underway in the US.
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Gore Peripheral Business leader Jill Paine said: “We are excited to explore the Gore Viafort Vascular Stent in people experiencing IVC occlusive disease.
“At Gore, we strive to build on our legacy of deliberate innovation and prioritise research that addresses unmet needs so we truly can help improve life.”
Last August, Gore reported that five-year data from the study of its GORE EXCLUDER Iliac Branch Endoprosthesis (IBE) for endovascular repair of iliac aneurysms confirmed its safety.
The prospective, multicentre trial established the efficacy and durability of the IBE in treating aortoiliac and iliac artery aneurysms.
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