W. L. Gore & Associates (Gore) has announced that the first U.S. patient has been enrolled in a prospective, non-randomized, multicenter, single-arm study with 5-year follow-up (NCT05409976) to evaluate the investigational GORE® VIAFORT Vascular Stent for the Treatment of Symptomatic Inferior Vena Cava (IVC) Obstruction with or without combined Iliofemoral Obstruction.
| CAUTION: Investigational device. Limited by United States law to investigational use. FIRST U.S. PATIENT ENROLLED IN GORE® VIAFORT Vascular Stent pivotal study FLAGSTAFF, Ariz., March 28, 2023 /PRNewswire/ -- W. L. Gore & Associates (Gore) has announced that the first U.S. patient has been enrolled in a prospective, non-randomized, multicenter, single-arm study with 5-year follow-up (NCT05409976) to evaluate the investigational GORE® VIAFORT Vascular Stent for the Treatment of Symptomatic Inferior Vena Cava (IVC) Obstruction with or without combined Iliofemoral Obstruction.
FIRST U.S. PATIENT ENROLLED IN GORE® VIAFORT VASCULAR STENT PIVOTAL STUDY The first U.S. patient was enrolled by Kush Desai, M.D. at Northwestern University Feinberg School of Medicine, Chicago, Illinois. “It is exciting to have enrolled the first U.S. patient, an important milestone for venous occlusive disease treatment,” stated Dr. Desai. “With no device options indicated, or frankly designed for both IVC and iliofemoral venous disease, implanting the GORE VIAFORT Vascular Stent in patients represents a significant step forward in research and ultimately management of these complex patients.” A company press release notes that the GORE VIAFORT Vascular Stent, which has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA), utilizes the Gore expanded polytetrafluoroethylene (ePTFE) technology in conjunction with a single wire, sinusoidal-wound nitinol frame. The Gore VIAFORT Vascular Stent IVC study is evaluating the device in a treatment range of 10–28 mm diameter for iliofemoral veins and the IVC. The study is being conducted in the U.S. under an approved investigational device exemption (IDE). 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. About Gore 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. Products listed may not be available in all markets. GORE, Together, improving life and VIAFORT and designs are trademarks of W. L. Gore & Associates.
SOURCE W. L. Gore & Associates, Inc. MPD Division |
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