FDA APPROVES NEW DIAMETER RANGE FOR THE GORE^® VIATORR^® TIPS Endoprosthesis with Controlled Expansion

Trusted TIPS device is the first approved to offer a 6–10 mm diameter range, delivering greater control to physicians treating portal hypertension.

FLAGSTAFF, Ariz. (October 27, 2025) — W. L. Gore & Associates Medical Products (Gore) today announced FDA approval of a new 6–10 mm diameter range for the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion.

Building on more than 25 years of innovation in portal hypertension, the expanded diameter range offers physicians greater flexibility to customize treatment based on individual patient needs, with the confidence that comes from Gore’s controlled expansion technology.

A legacy of lasting control

The VIATORR® Device enables consistent, tailored control of the shunt diameter to achieve a targeted portal pressure gradient. Once sizing is set, the device maintains a constant diameter — through at least 10 years as shown in benchtop testing.^a This lasting control is key when considering concerns about over shunting.

Previously approved with an 8–10 mm diameter range, the latest device iteration gives clinicians more options when balancing a desired portal pressure gradient and the risks associated with over shunting.

“When I think about my day-to-day practice, I do see a need for a smaller TIPS stent to benefit my patients. A 6-10 mm diameter range increases my ability to target a portal pressure gradient and meet the specific needs of my patients,” said Wael E.A. Saad, FSIR, MBBCH, Director of Interventional Radiology and Vice Chair of Image Guided Procedures at the University of Utah and a Gore consultant. “I trust in controlled expansion today and will trust it in smaller diameters.” 

Data-backed design, proven over time

The VIATORR® Device remains the only covered TIPS device with more than two decades of clinical performance and over 500 publications supporting a track record of patency and reliability. Constructed using Gore’s proprietary ePTFE graft lining, the device is designed to resist bile and mucin permeation — common causes of patency loss in TIPS.

“The controlled expansion technology built on the VIATORR® [Device] legacy of predictable performance in both de novo and revision TIPS procedures,” said Jason Belzer, Americas Business Leader, Medical Product Division. “Now, with a broader diameter range in a single device, we’re not only improving control during implantation — we’re delivering more options to physicians without increasing inventory.”

Balancing outcomes with care

TIPS procedures require a careful balance: too much shunting can lead to complications like hepatic encephalopathy and right heart overload, while too little may not sufficiently relieve the complications of portal hypertension.

“From the literature, we are seeing larger TIPS shunts are no longer necessary to establish excellent outcomes,” said Brett E. Fortune, MD, MSc, Medical Director of Liver Transplant Program and Associate Professor of Medicine at Montefiore Einstein and a Gore consultant. He continued, “I think it’s an exciting time that we’ll be able to use smaller shunts in select patients to minimize possible adverse risks such as hepatic encephalopathy, cardiac decompensation or hepatic decompensation, yet still have superior outcomes in controlling their bleeding and ascites.”

To learn more about the VIATORR® Device, including long-term patency and outcomes compared to non-TIPS therapy, visit goremedical.com/products/viatorr.

Medical Products

Gore engineers medical devices that treat a range of cardiovascular and other health conditions. With more than 55 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 approximately 13,000 Associates and a strong, team-oriented culture, Gore generates annual revenues of $5 billion. gore.com

Media contact

Jessica Moran
Goremedicalmedia@wlgore.com