GORE VIATORR TIPS Endoprosthesis Receives CE Mark for Expanded Diameter Range
GORE VIATORR TIPS Endoprosthesis with Controlled Expansion has received CE mark approval for its new 6-10mm diameter range, marking a significant advancement in portal hypertension treatment. W. L. Gore & Associates Medical Products announced this milestone on January 22, 2026, from Putzbrunn, Germany, introducing the first approved TIPS device offering this expanded diameter range.
Building on more than 25 years of innovation in portal hypertension treatment, the expanded diameter range provides physicians with greater flexibility to customize treatment according to individual patient needs. The device leverages Gore’s trusted Controlled Expansion technology, which has established a proven track record in interventional procedures.
Enhanced Control for Portal Hypertension Management
The GORE VIATORR TIPS device enables consistent and customized control of shunt diameter to achieve targeted portal pressure gradients. Previously approved for 8-10mm diameter range, the updated version now offers physicians broader options when balancing desired portal pressure gradients against risks associated with excessive shunt diameter. This advancement addresses a critical need in managing complications such as hepatic encephalopathy and cardiac overload.
“My research and clinical experience have repeatedly demonstrated that optimizing shunt diameter is a critical factor in improving outcomes for patients with portal hypertension. Devices with smaller diameters can significantly reduce complications such as hepatic encephalopathy and cardiac overload. The GORE VIATORR TIPS with Controlled Expansion is an important development, allowing precise alignment of shunt size to individual patient needs.”
Professor Filippo Schepis, Head of Hepatic Hemodynamics Laboratory, University Hospital of Modena, Italy
Proven Long-Term Performance and Clinical Evidence
The VIATORR device remains the only covered TIPS device with more than two decades of clinical performance data and over 500 publications supporting its track record of patency and durability. Manufactured using Gore’s proprietary ePTFE graft lining, the device is specifically designed to resist bile and myosin penetration, which are common causes of patency loss in TIPS devices.
“The introduction of the GORE VIATORR TIPS Endoprosthesis with a 6-10mm diameter range in clinical practice is expected to represent an important advancement in treating patients suffering from portal hypertension complications. Small-diameter TIPS devices have proven capable of effectively reducing portal pressure gradients while significantly minimizing risks of cardiac overload and hepatic encephalopathy.”
Roberto Miraglia, ISMETT, Palermo, Italy
Balancing Clinical Outcomes with Patient Safety
TIPS procedures require precise balance: excessive shunt diameter may lead to complications including hepatic encephalopathy and right heart overload, while insufficient diameter reduction may not fully alleviate portal hypertension complications. The expanded diameter range addresses this clinical challenge by providing more granular control options.
“Controlled Expansion technology builds on the VIATORR device’s long-standing legacy of predictable performance. Today, by providing a wider diameter range within a single device, we’re not only improving control during implantation but also offering physicians more options without any increase in their device inventory.”
Thomas Wiersma, Product Specialist EMEA Region, Gore Medical Products Division
Future Outlook for Portal Hypertension Treatment
This CE mark approval represents a significant step forward in personalized interventional radiology. The ability to tailor shunt diameter more precisely enables clinicians to optimize portal decompensation management while minimizing systemic effects. As clinical experience with the expanded diameter range grows, further refinements in treatment protocols are anticipated, potentially improving outcomes for patients with cirrhosis and portal hypertension complications worldwide.
For more information about the VIATORR device, including long-term patency data and outcomes compared to non-TIPS treatments, visit goremedical.com/en-emea/products/viatorr. Gore Medical Products continues its commitment to improving patient outcomes through research, education, and quality initiatives, building on a legacy of over 55 million implanted medical devices across more than 45 years.