Gore Launches Anti-Migration Assurance Program for GORE® VIABIL® Short Wire Biliary Endoprosthesis

Device is proven to reduce the risk of reintervention for patients with pancreatic and other cancers that obstruct the bile duct; replacement program can help limit overall costs of palliative care

FLAGSTAFF, Ariz. (October 4, 2017) – W. L. Gore & Associates, Inc. (Gore) announced today the launch of its Anti-Migration Assurance Program for the GORE® VIABIL® Short Wire Biliary Endoprosthesis. Under the program, Gore will provide a replacement device of identical dimensions for use with a patient whose device moves out of place within one year post-implantation. This helps to limit the overall costs of treating patients with cancer impacting the biliary tree, such as pancreatic cancer.

The GORE VIABIL Short Wire Biliary Endoprosthesis, which has an average reported migration rate of 0.2 percent1, is the only fully covered metal stent with demonstrated low migration and high long-term patency. Cancer patients receiving palliative care to alleviate bile duct obstruction caused by encroaching tumors can spend less time receiving and recovering from reinterventions.

“Reintervention with additional stents and additional procedures increases the patient’s risk of complications that can include infection or other complications from ERCP,” said Todd Baron, MD. “For a patient with malignant strictures in the biliary tree, that additional hospital time takes away from their quality of life, increases their costs and the provider’s costs, and causes undue suffering for a person who may be undergoing cancer treatment. The extremely low migration rates of the GORE VIABIL Short Wire Biliary Endoprosthesis help me limit patients’ risks and keep their quality of life and satisfaction with their outcomes as high as I am able, and I am pleased to see that performance now backed by Gore’s cost-reducing Anti-Migration Assurance Program.”

Fully covered atraumatic anchoring fins securely hold the GORE VIABIL Short Wire Biliary Endoprosthesis within the bile duct, resulting in a 0.2 percent average reported migration rate, the lowest of any fully covered, self-expanding biliary stent on the market.

Additionally, the device features low axial force, the recovery force that leads to straightening after being bent, and moderate radial force, which maintains and extends the luminal patency at the stricture once deployed. This combination provides ideal flexibility, allowing the device to conform to the curved bile duct while also securely maintaining its position. The preferred balance of these forces contribute to lower migration and higher patency rates. Clinical performance demonstrates the GORE VIABIL Short Wire Biliary Endoprosthesis maintains higher primary patency than the leading competitor at three, six, and 12 months.2, 3 Improved long-term patency can mean an improved quality of life for patients.

“We design our biliary devices to offer the lowest migration rates and highest patency rates in the industry,” said David Lane, business leader for Gore’s General Medical Products division. “To help physicians minimize the overall cost of biliary cancer care while limiting the impact of treatment on patient quality of life, we are proud to be able to provide an even higher level of reassurance with our new Anti-Migration Assurance Program.”

The GORE® VIABIL® Biliary Endoprosthesis and GORE VIABIL Short Wire Biliary Endoprosthesis feature the same fully covered metal stent made of Gore’s proprietary ePTFE material, which provides an absolute permanent barrier preventing growing tumors from infringing on the bile duct, a non-foreshortening design for accurate and secure placement, the lowest migration rates compared to other fully covered metal stents, and high patency rates. The recently launched GORE VIABIL Short Wire Biliary Endoprosthesis also features a next-generation catheter delivery system that allows the physician to deploy the stent independently, as opposed to requiring coordination with a nurse technologist.

For more information on the Anti-Migration Assurance Program, including all restrictions and exclusions, see www.goremedical.com/viabil.

ConMed is an authorized distributor of GORE VIABIL Biliary Endoprosthesis and GORE VIABIL Short Wire Biliary Endoprosthesis.

Full Anti-Migration Assurance Program Details:
Gore will provide a replacement device of identical dimensions for use with the patient whose device migrates within one year post implantation. The replacement device is only available if GORE® VIABIL® Biliary Endoprosthesis is implanted in accordance with the device Instructions for Use (The GORE® VIABIL® Biliary Endoprosthesis is intended for palliation of malignant strictures in the biliary tree) and the other terms of the program are satisfied. Replacement devices provided under this program are not eligible for the program. Claims under the program are limited to the replacement device. Upon receipt of the appropriate documentation, a replacement device will be provided pursuant to the program accompanied by a no-charge invoice shipped directly to the hospital. The hospital is responsible for reporting the no-charge replacement stent as a discount on the hospital’s cost report. All reports of migration will be documented appropriately within the Gore internal product surveillance process and additional information may be requested. Migrations are a known risk of any biliary endoprosthesis. The provision of a replacement device as part of the program does not constitute an admission that there was a device malfunction or defect or that Gore, its employees or agents, or the Gore device caused or contributed to any complications or injuries. Please see the device Instructions for Use for further information on the device contraindications, warnings, precautions, and potential adverse events. The program is subject to modification or termination by W. L. Gore & Associates without prior notification and this program is only applicable for the United States.

1. W. L. Gore & Associates, Inc.  Migration Summary for GORE® VIABIL® Biliary Endoprosthesis and Boston Scientific WALLFLEX Biliary RX Fully Covered Stent.  Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017.  [Literature Summary]. AW0010-EN3.
2. Kitano M, Yamashita Y, Tanaka K, et al.  Covered self-expandable metal stents with an anti-migration system improve patency duration without increased complications compared with uncovered stents for distal biliary obstruction caused by pancreatic carcinoma: a randomized multicenter trial.  American Journal of Gastroenterology 2013;108(11):1713-1722.
3. Krokidis M, Fanelli F, Orgera G, et al.  Percutaneous palliation of pancreatic head cancer: randomized comparison of ePTFE/FEP-covered versus uncovered nitinol biliary stents.  Cardiovascular & Interventional Radiology 2011;34(2):352-361.

About Gore Medical

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 VIABIL® and designs are trademarks of W. L. Gore & Associates. AW1135-EN1 SEPTEMBER 2017

About Gore

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

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