Medtech titan Boston Scientific (NYSE:BSX) unveiled new results from its WallFlex Biliary RX Stent study, touting perfect success in removing the device up to a year following implant.
The devices, used to prop open biliary strictures and provide drainage during surgery, also resulted in relatively low rates of re-stenting following removal.
About 75% of patients did not need another stent at the time that WallFlex was removed, according to a press release. Of those patients, about 85% remained stricture-free after an average of 20 months.
"The results of this study reinforce that fully covered self-expanding metal stent placement has the potential to reduce the number of [endoscopic retrograde cholangiopancreatogram] procedures required in the management of benign strictures," Boston Scientific endoscopy president David Pierce said in prepared remarks.
Boston Scientific plans to continue monitoring patients for 5 years to assess the long-term durability of the devices.
The WallFlex stent trials have gotten a lot of attention since their launch in May 2013, which was met with a spike in the company’s stock. The studies include 2 versions of the WallFlex stent: the fully covered and uncovered models. The fully-covered stent has a silicone polymer coating designed to prevent tissue ingrowth and a built-in loop for repositioning or removing the device, according to the release.
The company won 510(k) approval in October 2009 for the palliative treatment of malignant bile duct strictures using the WallFlex devices, adding an expanded CE Mark approval in the European Union a year later for the treatment of benign biliary strictures. In December 2012 Boston Scientific launched another trial of the WallFlex, comparing it with plastic stents in treating biliary strictures.