CAUTION: Investigational device. Limited by United States law to investigational use.
W. L. Gore & Associates initiates its GORE® VIAFORT Device Pivotal Clinical Study for the treatment of inferior vena cava occlusive disease.
Newswise — FLAGSTAFF, Ariz., Oct. 28, 2022 /PRNewswire/ -- 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, (i.e., prospective, multicenter, non-randomized, single-arm study NCT05409976) 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 Grafton, Auckland, New Zealand, by interventional radiologist Andrew Holden, M.D., Director of Regional Interventional Radiology at the Auckland Regional Public Health Service.
"This first implantation is an important milestone for venous occlusive disease treatment," Dr. 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."
The GORE VIAFORT Vascular Stent, which has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA), utilizes Gore's proven and durable 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 10–28 mm diameter for iliofemoral veins and the inferior vena cava. The study is being conducted in the U.S. 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."
For complete indications and other important safety information for Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU).
Gore engineers medical devices that treat a range of cardiovascular and other health conditions. With more than 50 million medical devices implanted over the course of more than 45 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers. Gore is joined in service with clinicians and through this collaboration we are improving lives. For more information, visit goremedical.com.
W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments — from outer space to the world's highest peaks to the inner workings of the human body. With more than 12,000 Associates and a strong, team-oriented culture, Gore generates annual revenues of $4.5 billion.
For more information, visit gore.com.
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22613308-EN AUGUST 2022