Gore: First patient enrolled in ascites study

W. L. Gore & Associates has reported the enrollment of the first patient in the Gore Early TIPS for Ascites Study at the Indiana University Hospital in Indianapolis. The objective of the study, which will enroll up to 150 patients, is to see whether the TIPS procedure with the Gore Viatorr TIPS endoprosthesis improves transplant-free survival versus large volume paracentesis in patients with cirrhosis of the liver and ascites, or the build up of fluid in the abdomen.

The current standard of care for patients with ascites is drainage of the fluid through paracentesis in combination with pharmacotherapy. The TIPS therapy is a minimally invasive procedure that requires only a small puncture in the jugular vein for insertion of the Gore Viatorr TIPS device. A TIPS creates a new channel to route blood flow through the damaged liver and into the main blood vessels that lead blood back to the heart. The Gore Viatorr TIPS endoprosthesis is the only covered stent that is indicated for TIPS creation and revision, according to a company statement.

"Most treatments for complications of portal hypertension improve the patient's condition without an impact on survival," explains Thomas Boyer, Chief of the Arizona Liver Institute and national principal investigator for the Gore clinical study, in the statement. "We believe in this new TIPS study for early resistant ascites and that an improvement in survival will be seen."

- see the Gore release