Category: Ear, Nose, Throat

Boston Scientific's WallFlex esophageal stent wins CE Marking, 510(k) clearance

November 20, 2009 by MassDevice staff

Boston Scientific Corp. (BSX) won 510(k) clearance from the U.S. Food and Drug Administration and CE Mark approval for its WallFlex fully covered esophageal stent.

The Natick, Mass.-based medical devices monolith's latest stent is designed to treat malignant esophageal obstructions caused by esophageal cancer. A partially covered version of the device won 510(k) clearance and a CE Mark last year.