October 19, 2011 – Boston Scientific has completed enrollment in a clinical trial to evaluate its WallFlex Biliary RX fully covered stent for the treatment of benign bile duct strictures (narrowing or blockages). This multi-center, prospective study enrolled 187 patients at 13 centers in 11 countries worldwide. Lead investigators in the study are Professor Jacques Deviere, M.D., Ph.D., of Hospital Erasme in Brussels, and Professor Guido Costamagna, M.D., of Policlinico A. Gemelli in Rome.
The study includes patients with bile duct strictures associated with post liver transplant anastomosis (connection of two structures), prior abdominal surgery such as cholecystectomy (gall bladder removal) and chronic pancreatitis (inflammation of the pancreas). The WallFlex Biliary RX Fully Covered Stent will remain in patients five to 11 months depending on the nature of the stricture. The trial will evaluate the removal of the stents from patients as well as the effectiveness of temporary stenting for long-term benign biliary stricture resolution. Patients will be followed for five years after stent removal.
"This is a key milestone for this important trial," said Deviere. "We look forward to the findings, which will determine the potential benefits of this stent as a less-invasive alternative to surgery in these types of patients and as an endoscopic treatment option that may require fewer ERCP(1) procedures than plastic stenting."
The WallFlex Biliary RX Stent is constructed of braided Platinol (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. Covered stents have a silicone polymer Permalume Coating designed to reduce the potential for tumor ingrowth, and an integrated retrieval loop for removing or repositioning the stent during the initial procedure in the event of incorrect placement.
The WallFlex Biliary RX fully covered, partially covered and uncovered stents are currently cleared in the United States and CE Mark countries for the palliative treatment of malignant bile duct strictures. The WallFlex Biliary RX fully covered stent was CE Marked in 2010 for an expanded indication to treat benign biliary strictures. The safety and effectiveness of the WallFlex Biliary RX Stenting System for use in the vascular system have not been established.
For more information: www.bostonscientific.com