Boston Scientific now has permission to market the device in treatment of refractory benign esophageal strictures, a narrowing of the esophagus that may be caused by scar tissue. The WallFlex "fully covered" stent can help prop the airway open and it features a silicone coating that helps prevent complications such as food impaction, tumor in-growth and fistulas.
The WallFlex stent also has FDA clearance for the U.S. market for palliative treatment of malignant esophageal strictures, but not for removal from malignant strictures and not for benign strictures, Boston Scientific noted. The WallFlex esophageal stent won CE Mark approval and original 510(k) from the FDA in 2009.
"The Nitinol wire braided construction allows the WallFlex Esophageal Stent to provide luminal patency in the presence of strictures or tumors," according to a Boston Scientific press release. "The stent is designed for gradual expansion, typically complete after 24 to 72 hours."
The WallFlex esophageal stent is part of the larger suite of WallFlex devices, including the biliary, colonic and duodenal stents. Boston Scientific last year launched a 294-subject clinical trial evaluating its WallFlex self-expanding biliary stent, compare using the 2 versions of its WallFlex stent before pancreatic cancer surgery with surgery without stent drainage. News of the study sent BSX shares soaring to a new 52-week high.
BSX shares closed last night at $13.38, a 0.6% bump on the day.