Boston Scientific gains WallFlex esophageal stent clearance
This article was originally published in The Gray Sheet
Executive Summary
Firm gains 510(k) clearance and CE-mark approval for its WallFlex fully covered esophageal stent, designed to treat malignant esophageal obstructions caused by tumors in patients with esophageal cancer, the firm announces Nov. 20. A partially covered version of the self-expanding esophageal stent debuted in 2008. The devices employ a proprietary Permalume silicone covering to prevent tumor ingrowth, seal concurrent esophageal strictures and help reduce food impaction, the company explains