Boston Scientific Corp. (NYSE:BSX) enrolled the first patient in a clinical trial of its WallFlex biliary stent for the treatment of benign bile duct strictures.
The Natick, Mass.-based medical device colossus said it plans to enroll 187 patients at 11 centers worldwide over the next 18 months for the trial, which will evaluate the removal of the stents from patients with benign bile duct strictures and the effectiveness of temporary stenting for long-term, benign biliary stricture resolution.
BSX said the study will include patients with bile duct strictures associated with post-liver transplant anastomosis, cholecystectomy (gall bladder removal) and chronic pancreatitis. The WallFlex stent will remain in patients four to 12 months, depending on the nature of the stricture, and patients will be followed for five years after the stents are removed, according to the company.
The Wallflex RX won 510(k) clearance from the Food & Drug Administration last October. A recent study comparing the Wallflex biliary stent, the most commonly used model to treat bile duct blockage, with Cook Medical’s Zilver stent found that the two devices have similar performance characteristics, both exhibiting stent occlusions in the low 20 percent of cases.
