Boston Scientific has reported that the first patient has been enrolled in a clinical trial to evaluate its WallFlex Biliary RX fully covered stent for the treatment of benign bile duct strictures.
The multi-center, prospective study plans to enroll 187 patients at 11 centers worldwide over the next 18 months.
The trial will evaluate the removal of the stents from patients with benign bile duct structures as well as the effectiveness of temporary stenting for long-term, benign biliary stricture resolution. The study will include patients with bile duct strictures associated with post liver transplant anastomosis, prior abdominal surgery such as cholecystectomy and chronic pancreatitis
The WallFlex Biliary RX Stent will remain in the patients four to 12 months depending on the nature of the stricture. Patients will be followed for five years after stent removal.
The Stent is constructed of braided, platinum-cored Nitinol wire (Platinol Wire) and features three key components, 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 family of stents is available in fully covered, partially covered and uncovered versions. The covered stents have a silicone polymer 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 Stents have received FDA clearance and CE Mark approval and are indicated for the palliative treatment of biliary strictures produced by malignant neoplasms. The safety and effectiveness of the System for use in the vascular system have not been established, said the company.
Deviere, professor, said: “We believe this trial is the most comprehensive of its kind and is critical to advancing our knowledge of fully covered, self-expanding metal stenting as an endoscopic treatment for benign biliary strictures. Use of the WallFlex Biliary RX Fully Covered Stents in these patients may provide significant benefits as a minimally invasive alternative to surgery.”