Boston Scientific Study Published In Gastroenterology Reports Successful Management Of Benign Biliary Strictures With Fully Covered Metal Stents
Large, Prospective, Multi-National Study Examines Management of Benign Biliary Strictures with Fully Covered Self-Expanding Metal Stents after Extended Indwell
MARLBOROUGH, Mass., Aug. 29, 2014 /PRNewswire/ — A Boston Scientific Corporation (NYSE: BSX) prospective, multinational study on stent removability and preliminary long term stricture resolution of benign biliary strictures has been published in the August issue of the peer-reviewed journal, Gastroenterology.
The multinational study(1) is being conducted in 11 countries and five continents, and examines removal of fully covered self-expanding metal stents (FCSEMS) after extended indwell (i.e., up to 12 months). The 187-patient study was designed to evaluate the ability to remove the Fully Covered WallFlex(TM) Biliary RX Stent after extended indwell and to determine treatment success of biliary obstructions resulting from benign biliary strictures.
-- The WallFlex Biliary RX Stents were successfully removed by endoscopy from all 155 patients in whom this procedure was attempted. -- Stricture resolution without the need to restent at the time of stent removal was successful in approximately 75% of patients. -- Approximately 85% of these patients remained stricture-free after a mean follow-up of 20 months. -- The study results demonstrate that FCSEMS are an effective treatment alternative to plastic stents, and may significantly reduce the need for multiple sequential Endoscopic Retrograde Cholangiopancreatogram (ERCP) stent exchanges and the associated complications and costs.
“Boston Scientific is committed to advancing science through investment in clinical research, and improving quality of life for patients,” said David Pierce, President, Endoscopy, Boston Scientific. “The results of this study reinforce that fully covered self-expanding metal stent placement has the potential to reduce the number of ERCP procedures required in the management of benign strictures.”
Follow up of the patients in the study is continuing for five years to determine the long-term durability of stricture resolution after stent removal. The Fully Covered WallFlex Biliary RX Stent is the only stent that is CE Marked with a 12-month removability indication. Additionally, Boston Scientific is currently enrolling patients in another multi-center, prospective, randomized study comparing removable, self-expanding metal stents to plastic stents for the treatment of benign biliary strictures secondary to Chronic Pancreatitis(2).
WallFlex Biliary RX Stents – Fully Covered, Partially Covered and Uncovered – are available in the United States and are indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and for use in preoperative drainage of malignant biliary strictures. WallFlex(TM) Biliary RX Stents are not indicated in the United States for use in benign biliary strictures. The safety and effectiveness of the stent for use in the vascular system have not been established.
WallFlex(TM) Biliary RX Stents are CE Marked for use in the palliative treatment of biliary strictures produced by malignant neoplasms and for treatment of benign biliary strictures.
For more information, visit Boston Scientific Endoscopy Resources online at www.bostonscientific.com/endo-resources.
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
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Global Media Relations
Boston Scientific Corporation
Susie Lisa, CFA
Boston Scientific Corporation
SOURCE Boston Scientific Corporation