Gore Viatorr TIPS Endoprosthesis Expanded Diameter Range Gains CE Mark Approval

January 30, 2026—Gore & Associates announced European CE Mark approval of a 6- to 10-mm diameter range for the Gore Viatorr TIPS—transjugular intrahepatic portosystemic shunt—endoprosthesis with controlled expansion. The device was previously approved with an 8- to 10-mm diameter range.

According to Gore, the expanded diameter range provides the flexibility to customize treatment based on individual patient needs. In October 2025, the company announced FDA approval of the expanded diameter range in the United States.

The Viatorr TIPS device enables consistent, tailored control of the shunt diameter to achieve a targeted portal pressure gradient. The latest device iteration gives clinicians more options when balancing a desired portal pressure gradient and the risks associated with overshunting, noted the company.

Professor Filippo Schepis, MD, and Roberto Miraglia, MD, commented on the Viatorr device in Gore’s press release.

“My research and clinical experience conducted with Professor F. Vizzutti have consistently shown that optimizing shunt diameter is critical for improving outcomes in portal hypertension,” stated Prof. Schepis. “Smaller-diameter devices may significantly reduce complications such as hepatic encephalopathy and cardiac overload. The Viatorr device with controlled expansion technology represents an important evolution, enabling precise tailoring of shunt size to individual patient needs. This is not just a technical refinement—it could provide a meaningful improvement for those living with portal hypertension.”

Dr. Miraglia added, “The introduction of [Gore Viatorr TIPS endoprosthesis with controlled expansion] with diameters ranging from 6 to 10 mm, into clinical practice is expected to represent a significant advancement in the management of patients with complications of portal hypertension. It is now well established that small diameter TIPS can achieve effective portal pressure gradient reduction while substantially lowering the risk of cardiac overload and hepatic encephalopathy. The availability of such devices will allow for a more tailored approach to shunt calibration, optimizing portal decompensation while minimizing systemic repercussions.”