Boston Scientific has completed enrolling patients in a clinical trial to demonstrate its WallFlex Biliary RX Fully Covered Stent to treat benign bile duct strictures.
The WallFlex Biliary RX fully covered stent is built with a Platinol (platinum-cored Nitinol) wire.
The stent features radial force – which aids in maintaining duct patency and resist migration, flexibility – to aid in conforming to tortuous anatomies and full-length radiopacity – to increase stent visibility under fluoroscopy.
The multi-center, prospective study has completed 187 patients enrollment at 13 centers in 11countries.
The study has enrolled patients with bile duct strictures associated with post liver transplant anastomosis, prior abdominal surgery such as cholecystectomy (gall bladder removal) and chronic pancreatitis.
Depending on the nature of the stricture, the WallFlex Stent will remain in patients from five to 11 months.
The trial will demonstrate 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.
Hospital Erasme in Brussels lead investigator Jacques Deviere said they 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 procedures than plastic stenting.