Boston Scientific, a global medical device manufacturer based in Natick, Massachusetts, announced in a press release that it has enrolled the first patient in a new clinical trial of its WallFlex Biliary RX stent technology. The WallFlex Biliary RX is a completely covered stent that incorporates the company’s proprietary self-expanding stent technology. The Biliary RX stent joins the company’s popular WallFlex stent product line.
According to information from Boston Scientific, the new clinical trial will compare the WallFlex Biliary RX stent to plastic control stents in the treatment of benign strictures in the bile duct. These strictures are often caused by chronic pancreatitis. With the clinical trial, the company hopes to demonstrate that its Biliary RX stent can be used to resolve strictures with a smaller number of procedures.
In prepared remarks, researchers at the Medical University of Vienna working with Boston Scientific stated, "Multiple plastic stenting remains an established treatment choice for biliary strictures caused by chronic pancreatitis. However, this form of treatment requires multiple stent exchanges and the long-term success rate is low. Treatment with removable fully covered SEMS could overcome these limitations.”
According to the company, the WallFlex Biliary RX stents are constructed in a way that facilitates removal of the device for up to one year. In an earlier single-arm study of the stent, researchers showed that the stents could be removed at any time up to one year after implantation. The previous 187-patient trial showed strong results for Wallflex stents. The new clinical trial will comprise 164 patients across the world.