Europe Expands Indication for Gore's Removable Viabil Biliary Endoprosthesis

April 27, 2010—W. L. Gore & Associates (Flagstaff, AZ) announced that it has received CE Mark approval for an expanded indication of the Gore Viabil biliary endoprosthesis in Europe. The new indication allows removal of the device up to 12 months after implantation for the treatment of benign or malignant biliary strictures. The Viabil first received CE Mark approval in December 1999 and US Food and Drug Administration (FDA) approval in January 2002 for the treatment of biliary strictures due to malignant neoplasms. 

According to the company, the Gore Viabil offers a strong, durable expanded polytetrafluoroethylene (ePTFE) barrier to tumor ingrowth and tissue attachment with atraumatic defeatable fin technology, making it well suited for treating benign and malignant strictures in the biliary tree.

The company stated that treatment options for benign biliary diseases previously were limited to reconstructive surgery, long-term multiple balloon dilatation, or repeated application and removal of either percutaneous internal/external drains or multiple internal small bore plastic stents over a 12-month period.

In the United States, the current indication for use of the Viabil is for treatment of biliary strictures caused by malignant neoplasms only. Plans for clinical testing to expand the indication to treat benign biliary strictures with subsequent removal in the United States are being developed, advised the company.