Boston Scientific Corp. (BSX) recently 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 in the U.S. and Europe. The new product is used for the treatment of malignant esophageal strictures (obstructions) caused by tumors in patients with resectable or non-resectable esophageal cancer.
With the new approval, Boston’s complete portfolio of WallFlex Stent family of self-expanding metal stents is now available in the U.S. , Europe and other international markets. The company had earlier received approval for marketing the WallFlex Partially Covered Esophageal Stent in U.S. and Europe in 2008.
The WallFlex Fully and Partially Covered Stents prevent tumor ingrowth by using a proprietary Permalume silicone covering. This also reduces the impaction of food. It is seen that patients suffering from esophageal cancer may have difficulties in swallowing, even while consuming liquids. The WallFlex Esophageal Stent prevents this by re-establishing patency (openness) of the esophagus. This in turn makes life easier for patients.
We think that the unique features of the WallFlex Fully Covered Stents are likely to make them widely acceptable amongst surgeons. This will boost demand for these stents which will increase the company’s top-line.
Boston Scientific is a manufacturer of medical devices and products used in a broad range of interventional medical specialties. The company faces significant competition across its product portfolio. The primary competitors include Johnson & Johnson (JNJ), Medtronic Inc. (MDT), Abbott Laboratories (ABT) and St. Jude Medical Inc. (STJ).
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