GORE VIABIL Biliary Endoprosthesis receives European CE Mark approval for expanded indication

W. L. Gore & Associates (Gore) today announced it has received European CE Mark approval for an expanded indication of the GORE® VIABIL® Biliary Endoprosthesis that allows removal of the device up to 12 months after implantation for the treatment of benign or malignant biliary strictures. The GORE® VIABIL® Biliary Endoprosthesis first received CE Mark approval in December 1999 and U.S. Food and Drug Administration (FDA) approval in January 2002 for the treatment of biliary strictures due to malignant neoplasms. The GORE® VIABIL® Biliary Endoprosthesis is the only biliary stent in the world to offer a strong, durable ePTFE barrier to tumor ingrowth and tissue attachment with atraumatic defeatable fin technology, making it ideal for treating benign and malignant strictures in the biliary tree.

“Gore is pleased to have received approval for this unique, expanded indication of the GORE® VIABIL® Biliary Endoprosthesis in order to advance care for patients in Europe who are affected by either malignant or benign biliary diseases”

A biliary stricture is an abnormal narrowing of the bile duct from the liver to the small intestine. It can be caused by surgical injury, such as following surgery to remove the gallbladder. Other causes may include cancer of the bile duct, damage due to gallstones and pancreatitis.

Previously, treatment options for benign biliary diseases 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. The removable GORE® VIABIL® Biliary Endoprosthesis eliminates the need for multiple procedures by offering proven, long-term patency and the versatility to meet a variety of patient and physician needs.

In order for a stent to be placed in the biliary tree and subsequently removed, it must be fully covered with a non-porous material to prevent tissue in growth of either the lining or the metal stent structure long term. To accomplish this, the GORE® VIABIL® Biliary Endoprosthesis features a thin film of composite polytetrafluoroethylene.

"Gore is pleased to have received approval for this unique, expanded indication of the GORE® VIABIL® Biliary Endoprosthesis in order to advance care for patients in Europe who are affected by either malignant or benign biliary diseases," said Ron Anderson, General Surgical Products Business Unit Leader at Gore. "Treating benign diseases of the biliary tree presents a very challenging task for both the doctor and patient. The Gore device provides the perfect balance of radial strength and conformability to the anatomy, all while ensuring accurate placement with a patented smooth, precision-controlled deployment system and the ability to be removed after resolution of the stricture and completion of therapy."

The current indication for use of the GORE® VIABIL® Biliary Endoprosthesis in the United States is for treatment of biliary strictures due to 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.

GORE® VIABIL® Biliary Endoprosthesis is marketed worldwide by Gore Medical Products Division and to the gastroenterologist in the United States by Conmed Endoscopic Technologies, Inc. It will be showcased at Conmed Endoscopic Technologies booth #1235 at the Digestive Disease Week conference on May 1-5, 2010 in New Orleans, LA.

Source W. L. Gore & Associates