FLAGSTAFF, AZ (December 8, 2004) - W. L. Gore & Associates, Inc. has received U.S. Food and Drug Administration (FDA) approval to market the GORE VIATORR® Endoprosthesis, an advanced technology, implantable device to treat portal hypertension in both de novo and revision Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedures. The VIATORR® Endoprosthesis is also indicated for the treatment of tracheobronchial strictures.
The GORE VIATORR® TIPS 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 configurations, the VIATORR® TIPS Endoprosthesis is designed to provide secure anchoring with minimal kinking.
The GORE VIATORR® TIPS Endoprosthesis is an innovative solution for TIPS in both de novo and revision procedures. The device's unique ePTFE graft lining minimizes transmural permeation of bile and mucin (which are common causes of patency loss) and reduces tissue ingrowth into the graft for ease of surgical dissection during liver transplantation.
Additionally, the unlined nitinol "chain-link" segment of the GORE VIATORR® TIPS Endoprosthesis allows for nutrient portal perfusion.
"Physicians treating portal hypertension must be concerned about maintaining shunt patency and minimizing complications, such as encephalopathy and liver failure following TIPS creation," says Woody Watson, Product Specialist for the VIATORR® Device family. "The high-performance characteristics of the GORE VIATORR® TIPS Endoprosthesis offer an improved solution in this demanding application."
The GORE VIATORR® TIPS Endoprosthesis is available in diameters of 8, 10 and 12 mm, and its graft-lined length ranges from 4 to 8 cm. The endoprosthesis is delivered over a guidewire diameter of = 0.038 in. Placement is via a 10 Fr introducer sheath.
W. L. Gore & Associates, Inc., is developing a family of nitinol-ePTFE endoprosthesis products for various vascular and non-vascular applications. Among the Gore stent graft products currently available in the U.S. are the VIABIL® Endoprosthesis for the treatment of malignant biliary strictures, the VIABAHN® Endoprosthesis for tracheobronchial applications, and the EXCLUDER® Bifurcated Endoprosthesis for treatment of abdominal aortic aneurysms.
ABOUT W. L. GORE & ASSOCIATES, INC.
Gore is a leading manufacturer of thousands of advanced technology products for the electronics, industrial, fabrics and medical markets. The Gore Medical Products Division provides creative therapeutic solutions to complex medical problems. Gore Medical provides such products as synthetic vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, and sutures for use in vascular, cardiac, general surgery and orthopedic procedures. With more than 10 million implants, these devices have been saving and improving the quality of lives worldwide for nearly 30 years.
GORE, EXCLUDER®, VIABAHN®, VIABIL® and VIATORR® are trademarks of W. L. Gore & Associates.
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W. L. Gore & Associates, Inc.
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800-528-8763