Gore & Associates (Gore) has received European CE mark approval for an expanded indication of Viabil Biliary Endoprosthesis that allows removal of the device up to 12 months after implantation for the treatment of benign or malignant biliary strictures.
Gore claimed that the Gore Viabil Biliary Endoprosthesis has first received CE mark approval in December 1999 and FDA approval in January 2002 for the treatment of biliary strictures due to malignant neoplasms. It is the only biliary stent 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 said that 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.
The current indication for use of the Gore Viabil Biliary Endoprosthesis in the US 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 US are being developed.
Ron Anderson, leader of general surgical products business unit at Gore, said: “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.
“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.”
Gore Viabil Biliary Endoprosthesis is marketed worldwide by Gore Medical Products Division and to the gastroenterologist in the US by Conmed Endoscopic Technologies.