Medical device company Boston Scientific (NYSE:BSX) enrolled its 1st patient in a new study evaluating its WallFlex Biliary RX fully covered self-expanding stents, part of the WallFlex suite of stents which the company says "is the most frequently implanted biliary metal stent worldwide."
The new study will compare the WallFlex Biliary RX to plastic stents in treatment of benign bile duct strictures that are caused by chronic pancreatitis, hoping to demonstrate that the metal WallFlex stent can resolve strictures in fewer procedures, according to a press release.
"Multiple plastic stenting remains an established treatment choice for biliary strictures caused by chronic pancreatitis," study investigator Professor Puspok of the Medical University of Vienna, who has worked on other WallFlex studies as well, said in prepared remarks. "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."
The WallFlex Biliary RX stents are designed to enable removal of the devices for up to 1 year following implant. In a previous single-arm study of the device researchers reported that they were able to safely remove the stents any time within that 1 year and that short-term treatment findings were stronger for WallFlex stents than had been reported in studies of plastic stents.
The previous WallFlex study, which involved 187 patients and launched in January 2010, is still gathered data for a 5-year follow-up, according to a press release.
The new study will involve 164 patients at sites in Australia, Austria, Belgium, Canada, France, Germany, Hong Kong, India, Italy and the Netherlands.
