Boston Scientific Corporation's (NYSE: BSX) WallFlex® Biliary RX Fully Covered Stent has received Health Canada approval for the treatment of benign biliary strictures, which supplements its current indication for management of malignant biliary strictures (narrowing or blockage).
"Benign biliary strictures related to an injury, anastomosis or chronic pancreatitis may be challenging to resolve," said Andre Roy, M.D., FRCSC, Director of the Liver Transplantation Program at Hopital Saint-Luc du Centre Hospitalier de l'Universite de Montreal. "The WallFlex Stent incorporates the latest innovations in self-expanding metal stent technology and may provide significant benefits as a less-invasive alternative to surgery in these patients."
"Current management of benign biliary strictures typically includes repeated dilation with balloons and plastic stents, however, this new approval allows me to offer a one-step alternative, which may help to reduce the number of procedures my patients must undergo, while providing the best possible care and containing costs," said Paul Kortan, M.D., Gastroenterologist at St. Michaels Hospital in Toronto.
The WallFlex Biliary RX Stent is constructed of braided, Platinol(TM) (platinum-cored Nitinol) wire and features three key attributes: radial force to help maintain duct patency and resist migration, flexibility to aid in conforming to tortuous anatomies and full-length radiopacity to enhance stent visibility under fluoroscopy. The WallFlex Biliary RX family of stents is available in fully covered, partially covered and uncovered versions. The covered stents have a silicone polymer Permalume® coating designed to reduce the potential for tumor/tissue ingrowth, and an integrated retrieval loop for removing or repositioning the stent in the event of incorrect placement during the initial procedure or for removal up to 12 months following initial placement in benign strictures.
"The WallFlex Biliary RX Stent leverages existing Boston Scientific technologies, while advancing performance with new features based on physician feedback," said David Pierce, President of Boston Scientific's Endoscopy Division. "With our full line of WallFlex Biliary, Enteral and Esophageal Stents, Boston Scientific offers the most comprehensive range of innovative treatment options to diagnose, palliate and treat patients with gastrointestinal diseases."
The complete line of WallFlex Biliary RX Stents has previously received Health Canada, CE Mark and FDA clearance for the palliative treatment of malignant biliary strictures. The WallFlex Stent is the most frequently implanted biliary metal stent in the U.S., Canada and Europe.
In the U.S., the WallFlex Biliary RX Fully Covered Stent is not approved for the treatment of benign biliary strictures. The safety and effectiveness of the WallFlex Biliary RX Stent System for use in the vascular system have not been established.
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