Wednesday, June 07, 2023
W. L. Gore & Associates (Gore) has announced the initiation of a prospective, non-randomized, multicenter, single-arm study with a five-year follow-up (NCT05489588). The study aims to assess the effectiveness of the investigational GORE® VIAFORT Vascular Stent in treating symptomatic iliofemoral venous obstruction. The first patient has been enrolled in the United States for this study.
The GORE VIAFORT Vascular Stent iliofemoral Study in the United States has enrolled its first patient, led by Dr. David J. Dexter II at Sentara Vascular Specialists in Norfolk, Virginia. Dr. Dexter expressed enthusiasm for the study, mentioning that despite several FDA-approved stents available, the VIAFORT Device's unique flexibility and radial force make it an appealing option for clinical trials.
The GORE VIAFORT Vascular Stent utilizes Gore's expanded polytetrafluoroethylene (ePTFE) technology combined with a single wire, sinusoidal-wound nitinol frame, as stated in a company press release. The ongoing study focuses on evaluating the device's efficacy in treating iliofemoral veins within a diameter range of 10 to 20 mm. The study is conducted under an approved investigational device exemption (IDE) in the United States.
With a legacy of over 45 years and more than 55 million implanted medical devices, Gore is dedicated to enhancing patient outcomes through research, education, and quality initiatives. Their medical devices cater to various cardiovascular and health conditions. The company prioritizes product performance, user-friendly design, and quality of service, resulting in sustainable cost savings for physicians, hospitals, and insurers. Gore collaborates closely with clinicians to drive improvements in healthcare and positively impact lives. Visit goremedical.com for further information.