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Gore launches replacement program for migrating biliary stents
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The manufacturer of the Gore Viabil short wire biliary endoprosthesis, a fully covered, self-expanding metal biliary stent, announced it has launched an anti-migration assurance program that will replace devices that migrate within a year of implantation.
While the device has been shown to lower the need for reintervention in patients with pancreatic and other cancers that obstruct the bile duct, and has an average reported migration rate of 0.2%, this replacement program can help control the overall costs of palliative care, according to a press release.
“Reintervention with additional stents and additional procedures increases the patient’s risk of complications that can include infection or other complications from ERCP,” Todd Baron, MD, professor of medicine and director of advanced therapeutic endoscopy at University of North Carolina Hospital, Chapel Hill, said in the press release. “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.”
The device is made with the manufacturer’s proprietary ePTFE material, which creates a permanent barrier to prevent tumor growth into the bile duct, and enables accurate and secure placement, high patency and “the lowest migration rates” among fully covered metal stents, according to the press release. Clinical performance shows the device “maintains higher primary patency than the leading competitor at 3, 6, and 12 months,” the press release also noted.
“We design our biliary devices to offer the lowest migration rates and highest patency rates in the industry,” David Lane, business leader for Gore’s General Medical Products division, said in the press release. “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.”
Under the terms of the replacement program, which only applies to patients in the U.S., the manufacturer will replace a device that migrates within 1 year with a device of identical dimensions, as long as the original device was implanted in accordance with the manufacturer’s instructions, and other program terms are met. The program will provide replacement devices after required documents are received, and a no-charge invoice will be directly provided to the hospital, according to the press release.
Disclosures: Baron reports he is a consultant for W.L. Gore, and Lane is employed by W.L. Gore.