Boston Sci Wins Biliary Stent Approval by FDA

Boston Scientific just announced FDA approval of the WallFlex Biliary RX fully and partially covered stents “for the palliative treatment of malignant bile duct strictures.” The device has already been approved in Europe and now it will be available on both continents.

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™ 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 Biliary RX Stent is designed to maintain patency and resist migration….
TheWallFlex Biliary RX Stents also feature a closed-cell construction designed to resist tissue ingrowth(2), looped ends intended to reduce the risk of tissue trauma, and flared ends to help reduce the risk of stent migration. The proprietary, durable silastic polymer (Permalume(®)) covering of the fully and partially covered stents is designed to reduce the potential for tumor ingrowth. In addition, the WallFlex Biliary RX Stent incorporates an integrated retrieval loop for removal during the initial stent placement procedure, which can be used in the event of incorrect placement.
Preliminary results from Dr. Petersen’s study were reported at United European Gastroenterology Week (UEGW) in 2008. Results showed that the fully covered WallFlex Biliary RX Stent yielded technically successful placement, low rates of re-intervention (two percent) and recurrent biliary obstruction, and minimal occurrence of migration (two percent) and complications. With 98 percent of patients meeting the primary endpoint of clinical palliation of the biliary obstruction until completion of follow-up, study results suggest that the fully covered WallFlex Biliary RX Stent may successfully palliate most patients with malignant distal biliary obstructions.
Also presented at UEGW were preliminary data on a 70-patient WallFlex Biliary RX partially covered stent study led by Primary Investigator Guido Costamagna, M.D., Head of Digestive Endoscopy at Universita Cattolica del Sacro Cuore in Rome. Preliminary results of the study demonstrate that the partially covered metal stent may palliate most patients with malignant biliary obstructions.

Press release: Boston Scientific Announces FDA Clearance and U.S. and European Availability of WallFlex® Biliary RX Covered Stents…
Product page: WallFlex® Biliary RX Stents…
Video below the fold demonstrating the features of the WallFlex Biliary RX: