Boston Scientific has announced that it has received FDA and CE Mark approval for its Advanix Biliary Plastic Stents. These stents will be marketed for the treatment of biliary strictures from stones as well as from benign and malignant processes in the biliary system.
According to Boston Scientific, the new stent has features that improve navigation around tortuous anatomy. The stent is pre-loaded within the delivery system, ensuring precise delivery. Boston plans to release the device in the U.S. this quarter.
“The Advanix Biliary Stent System features significant developments in plastic stent technology,” said Stuart Sherman, M.D., Clinical Director of Gastroenterology and Hepatology, and Director of the ERCP(2) program at Indiana University Medical Center in Indianapolis. “Improvements in design provide greater procedural control and efficiency while navigating tight strictures in the bile ducts, facilitating stent placement and removal. The thin wall and increased inner diameter of the stent may provide extended patency of the duct, which could improve treatment outcomes.”
Press release: Boston Scientific Announces FDA Clearance and CE Mark Approval for Advanix™ Biliary Stents