Boston Scientific Announces FDA Clearance and U.S. and European Availability of WallFlex(R) Biliary RX Cove...(liary RX Stent is designed to maintain p...),Health

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.

"Boston Scientific continues to fulfill our promise to deliver industry-leading, innovative technologies that enable physicians to best diagnose and treat digestive diseases, and enhance quality of life for patients," said Michael Phalen, President, Boston Scientific Endoscopy. "The WallFlex Biliary RX Stent leverages existing Boston Scientific technologies, while advancing performance with new features such as a unique Platinol Wire construction. We believe we are truly delivering the next generation of stents for the treatment of malignant bile duct strictures."

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 o
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