BSX WallFlex Stent Gets CE Mark For Refractory Benign Esophageal Strictures

(RTTNews) - Medical device maker Boston Scientific Corp. (BSX) said Friday that it has received CE Mark in Europe for its WallFlex Esophageal Fully Covered Stent to treat refractory benign esophageal strictures.

Benign esophageal strictures are a narrowing of the esophagus caused by scar tissue. The primary treatment is dilation of the esophagus, which may need to be repeated after a period of time if the stricture recurs.

The Nitinol wire braided construction allows the WallFlex Esophageal Stent to provide luminal patency in the presence of strictures or tumors. The stent is designed for gradual expansion, typically complete after 24 to 72 hours, and features a Permalume silicone coating that is designed to prevent tumor in-growth, seal concurrent esophageal fistulas and help reduce food impaction. An additional feature is a Teflon™ coated polyester suture that enables removal from refractory benign strictures for up to eight weeks, potentially saving patients from having to visit the hospital to undergo additional dilations to treat their stricture.

Both fully covered and partially covered WallFlex Esophageal Stents have previously received CE Mark and U.S. Food and Drug Administration clearance for the palliative treatment of malignant esophageal strictures.

WallFlex Esophageal Stents are not approved for removal from malignant strictures and are not approved in the U.S. for the treatment of refractory benign esophageal strictures.