Monday, November 23, 2009

Boston Scientific Gets CE Mark and FDA Clearance for Covered Esophageal Stent

Filed under: GI , Surgery

Boston Scientific has announced that its WallFlex® Fully Covered Esophageal Stent received 510(k) clearance from the FDA as well as EU's CE Mark of approval. The stent is designed for esophageal strictures caused by cancer of the esophagus. The use of stents can re-open a blocked esophagus, allowing patients to consume solids and liquids once again.

More from the press release:

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. 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 (involuntary contractions) and strictures. In addition, the WallFlex Fully Covered Stent may be reconstrained up to 75 percent deployment.

Read more here...

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