Boston Scientific (BSX) Receives 510(k) Clearance and CE Mark on WallFlex
Boston Scientific Corporation (NYSE: BSX) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and CE Mark approval to market its WallFlex Fully Covered Esophageal Stent for the treatment of malignant esophageal strictures (obstructions) caused by tumors in patients with resectable or non-resectable esophageal cancer.
The WallFlex® Partially Covered Esophageal Stent was cleared by the FDA and received CE Mark in 2008. Both stents -- along with the complete WallFlex Stent family of self-expanding metal stents (SEMS) -- will be available for hands-on demonstration at the GASTRO 2009 conference, which is being held November 21-25 in London.
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