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Boston Scientific Announces FDA Clearance and U.S. and European Availability of WallFlex(R) Biliary RX Covered Stents
Date:10/6/2009

NATICK, Mass., Oct. 6 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its WallFlex(®) Biliary RX fully and partially covered stents for the palliative treatment of malignant bile duct strictures. The WallFlex Biliary RX uncovered stent was cleared by the FDA in 2006. All three models of the WallFlex Biliary RX Stenting System -- fully covered, partially covered and uncovered -- are now available in both the United States and Europe.

"The WallFlex Biliary RX Stent System represents the next stage in self-expandable metal stent technology. The stent has greater flexibility to aid with placement in tortuous anatomies and new features such as flared ends that may reduce the risk of migration," said Kenneth F. Binmoeller, M.D., Director of Interventional Endoscopy at California Pacific Medical Center, and an investigator for the WallFlex Biliary RX fully covered stent study.

The WallFlex Biliary RX Stent is designed to offer the benefits of prior-generation stents, such as the industry-leading WALLSTENT(®) Endoprosthesis, while incorporating new features to accommodate a range of anatomical and clinical requirements. Based on extensive research and physician feedback, the WallFlex Biliary RX Stent employs a platinum-cored Nitinol construction designed to deliver on three critical components: radial force, flexibility and radiopacity. The Platinol(TM) Wire provides greater flexibility - 30 percent more than the WALLSTENT Endoprosthesis - to help the stent conform within tortuous anatomies. The enhanced full-length radiopacity offered by the Platinol Wire and the reconstrainable delivery system are designed to allow for more precise stent placement, while the radial force of the WallFlex Bi
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