FLAGSTAFF, Ariz. (March 9, 2017) – W. L. Gore & Associates, Inc. (Gore) announces the FDA approval and U.S. launch of the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion for Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedures.
"I used the new GORE VIATORR TIPS Endoprosthesis with Controlled Expansion in the first U.S. patient with life threatening hepatorenal syndrome and impending liver failure, with nine cc of iodinated contrast. She was discharged to hospice the next day, but three weeks later, she is at home, free of ascites, jaundice, encephalopathy, and with great renal function. She’s headed to Florida for six weeks,” said Ziv Haskal, MD, Interventional Radiologist, Charlottesville, Virginia. “The ability to tune the diameter of the GORE VIATORR TIPS Endoprosthesis with Controlled Expansion will let me better serve patients and expand the role of TIPS in patients with need."
Early clinical experiences were shared at the Society of Interventional Radiology’s 2017 meeting in Washington, D.C. on Monday, March 6. Clinical findings will be revealed at the EASL International Liver Congress in April.
The addition of controlled expansion capability builds on the legacy of proven patency in de novo and revision TIPS procedures of the GORE® VIATORR® TIPS Endoprosthesis. The GORE VIATORR TIPS Endoprosthesis with Controlled Expansion features the same proprietary ePTFE graft lining that minimizes transmural permeation of bile and mucin (common causes of patency loss). With the new controlled expansion capability, physicians can start at the smallest diameter (8 mm) and balloon up as needed during implantation to optimize the diameter until the target pressure gradient is reached. Diameter expansion was no more than 0.25 mm over a simulated 10-year period at physiological portal pressures (benchtop data on file). Further, the new endoprosthesis now covers a range of diameters between 8 and 10 mm in a single device, helping to simplify inventory.
Gore is also releasing its new GORE TIPS Set, composed of the specialized GORE TIPS Needle and GORE® TIPS Sheath. The set offers features designed to improve control, accuracy, and visual feedback during the most crucial and technically challenging steps of the TIPS procedure and device implantation processes. The GORE TIPS Sheath features an exclusive interlocking feature that secures the dilator hub and sheath during advancement for maximum component stability. It offers a transparent tapered sheath hub that provides a clear view of the access sleeve position to help visually confirm a device is properly loaded. The GORE TIPS Needle offers a sharp tip that aids more precise puncturing, stiffness for responsive torque control, and an ergonomic handle for a stable grip. A status band confirms needle tip sheathing. The GORE TIPS Needle and GORE TIPS Sheath are available either as a set or individually, providing inventory and purchasing flexibility.
For more information on the GORE VIATORR TIPS Endoprosthesis with Controlled Expansion and the treatment of portal hypertension, please visit http://www.goremedical.com/products/viatorr---controlled-expansion.
For more information on the GORE TIPS Set, please visit http://www.goremedical.com/products/tipsset
About W. L. Gore & Associates, Inc.
W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Founded in 1958, Gore has built a reputation for solving complex technical challenges in the most demanding environments — from revolutionizing the outerwear industry with GORE-TEX® fabric to creating medical devices that improve and save lives to enabling new levels of performance in the aerospace, pharmaceutical and mobile electronics markets, among other industries. The company is also known for its strong, team-oriented culture and continued recognition from the Great Place to Work® Institute. Headquartered in Newark, Del., Gore employs approximately 10,000 Associates and generates annual revenues that exceed $3 billion. www.gore.com
Medical Products Division
Gore Medical Products Division engineers devices that treat a range of cardiovascular and other health conditions. With more than 40 million medical devices implanted over the course of more than 40 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers. Gore is joined in service with clinicians and through this collaboration we are improving lives. www.goremedical.com
Products listed may not be available in all markets. GORE®, GORE-TEX®, and VIATORR® are trademarks of W. L. Gore & Associates.