Health Canada approves GORE VIABIL Biliary Endoprosthesis device

W. L. Gore & Associates, Inc. (Gore) today announced it has received approval from Health Canada for the Removable GORE VIABIL Biliary Endoprosthesis. This device is designed for the treatment of benign or malignant biliary strictures followed by optional removal up to 12 months after implantation. The Removable GORE VIABIL Biliary Endoprosthesis is the only fully covered, self expanding biliary stent in the world that offers a strong, durable barrier against tumor ingrowth and tissue attachment with anti-migration fin technology, thereby making it ideal for treating benign and malignant strictures in the biliary tree.

The Removable GORE VIABIL Biliary Endoprosthesis offers patients an improved alternative to traditional biliary stricture treatments. The easy-to-use pull-line delivery system allows for a smooth implantation with excellent accuracy while the atraumatic, deformable anti-migration fins minimize the chance for device migration. Coupled with Gore's unique non-porous ePTFE/FEP covering, this combination provides for proven, long-term patency, the earmark of effective biliary stents.

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, cancer of the bile duct, or damage due to gallstones and pancreatitis. Previously, treatment options for benign biliary diseases were limited to reconstructive surgery, long-term multiple balloon dilatations, or repeated application and removal of either percutaneous drains or multiple small bore plastic stents over a 12-month period. The Removable GORE VIABIL Biliary Endoprosthesis replaces the need for multiple procedures with a proven, long-term approach that meets both patient and physician needs.

"Gore is pleased to have received Heath Canada approval for the Removable GORE VIABIL Biliary Endoprosthesis in order to advance care for patients in Canada who are affected by either malignant or benign biliary diseases," said Ron Anderson, associate with the General Medical Products Business. "Treating strictures of the biliary tree presents a very challenging task for both the doctor and patient. Our commitment to performance through design ensures that the Gore device provides the perfect balance of radial strength and conformability to the anatomy, all while enabling the ability to be removed after resolution of the stricture and completion of therapy."

The GORE VIABIL Biliary Endoprosthesis is marketed worldwide by the Gore Medical Products Division and to the gastroenterologist in Canada by ConMed Canada.