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GORE VIATORR Endoprosthesis Receives FDA Approval For TIPS.


FLAGSTAFF Flagstaff, city (1990 pop. 45,857), seat of Coconino co., N Ariz., near the San Francisco Peaks; inc. 1894. Lumbering, ranching, and a lively tourist trade thrive in the region, where many ruined pueblos, numerous state parks, several lakes, and large pine forests , Ariz. -- W. L. Gore & Associates Inc. has received U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) approval to market the GORE VIATORR(R) Endoprosthesis, an advanced technology, implantable device to treat portal hypertension in both de novo and revision Transjugular Intrahepatic Portosystemic Shunt Transjugular intrahepatic portosystemic shunt (TIPS)
A transjugular intrahepatic portosystemic shunt (TIPS) is a radiology procedure in which a tubular device is inserted in the middle of the liver to redirect the blood flow.

Mentioned in: Bleeding Varices
 (TIPS) procedures. The VIATORR(R) Endoprosthesis is also indicated for the treatment of tracheobronchial tracheobronchial /tra·cheo·bron·chi·al/ (-brong´ke-al) pertaining to the trachea and bronchi.

tra·che·o·bron·chi·al
adj.
Of or relating to the trachea and the bronchi.
 strictures.

The GORE VIATORR(R) 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(R) TIPS Endoprosthesis is designed to provide secure anchoring with minimal kinking.

The GORE VIATORR(R) TIPS Endoprosthesis is an innovative solution for TIPS in both de novo and revision procedures. The device's unique ePTFE graft lining minimizes transmural transmural /trans·mu·ral/ (trans-mu´ral) through the wall of an organ; extending through or affecting the entire thickness of the wall of an organ or cavity.

trans·mu·ral
adj.
 permeation of bile and mucin mucin: see glycoprotein.  (which are common causes of patency pa·ten·cy
n.
The state or quality of being open, expanded, or unblocked.



patency

the condition of being open.
 loss) and reduces tissue ingrowth ingrowth /in·growth/ (-groth) an inward growth; something that grows inward or into.

in·growth
n.
Something that grows inward or into a part of the body.
 into the graft for ease of surgical dissection during liver transplantation.

Additionally, the unlined nitinol "chain-link" segment of the GORE VIATORR(R) 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," said Woody Watson, product specialist for the VIATORR(R) device family. "The high-performance characteristics of the GORE VIATORR(R) TIPS Endoprosthesis offer an improved solution in this demanding application."

The GORE VIATORR(R) 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 less than or equal to 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 United States are the VIABIL(R) Endoprosthesis for the treatment of malignant biliary strictures, the VIABAHN(R) Endoprosthesis for tracheobronchial applications, and the EXCLUDER(R) Bifurcated bi·fur·cate  
v. bi·fur·cat·ed, bi·fur·cat·ing, bi·fur·cates

v.tr.
To divide into two parts or branches.

v.intr.
To separate into two parts or branches; fork.

adj.
 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(R), VIABAHN(R), VIABIL(R) and VIATORR(R) are trademarks of W. L. Gore & Associates.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Dec 8, 2004
Words:448
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