W. L. Gore & Associates Inc has received 510(k) clearance from the U.S. Food and Drug Administration to market the VIATORR Endoprosthesis. The VIATORR Endoprosthesis is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms or in benign strictures after all alternative therapies have been exhausted.
The VIATORR Endoprosthesis is a flexible, self-expanding, implantable endoprosthesis with a proprietary, reduced permeability expanded polytetrafluoroethylene (ePTFE) graft lining. Featuring improved radial compression strength over other commercial stent designs, the VIATORR Endoprosthesis is designed to provide secure anchoring with minimal kinking and tissue deformation. The VIATORR Endoprosthesis is available in diameters from 8 to 12 mm, and its graft-lined length ranges from 4 to 8 cm. The endoprosthesis guidewire diameter is less than or equal to 0.038 in. Placement is via a 10 Fr introducer sheath.