Boston Scientific Receives CE Mark, FDA 510(k) Clearance for WallFlex Fully Covered Esophageal Stent

Boston Scientific Corp. has received 510(k) clearance from the U.S. Food and Drug Administration and CE Mark approval to market its WallFlex Fully Covered Esophageal Stent for the treatment of malignant esophageal strictures caused by tumors in patients with resectable or non-resectable esophageal cancer, according to a Boston Scientific news release.

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Patients with obstructions due to esophageal cancer may have difficulty swallowing, resulting in severely limited quality of life, and complete blockages of the esophagus can prevent liquid consumption, according to the release. The WallFlex Esophageal Stent allows physicians to re-establish patency of the esophagus, enabling resumption of oral intake.

The WallFlex Fully and Partially Covered Stents employ a proprietary Permalume silicone covering designed to prevent tumor ingrowth, seal concurrent esophageal fistulas and help reduce food impaction, according to the release. The stents’ progressive-step, flared ends are designed to reduce the risk of migration and may assist in anchoring the fully covered stent within the esophageal lumen. The multiple wire-braided construction is engineered to allow the stent to adjust to forces within the esophagus such as peristalsis and strictures. The WallFlex Fully Covered Stent may be reconstrained up to 75 percent deployment.

Read the Boston Scientific release about the WallFlex Fully Covered Esophageal Stent.

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