Boston Scientific Gets FDA Clearance For WallFlex Biliary RX Stents

Boston Scientific has received 510(k) clearance to market its WallFlex Biliary RX fully and partially covered stents, for the palliative treatment of malignant bile duct strictures from the FDA.

Reportedly, the FDA cleared WallFlex Biliary RX uncovered stent in 2006. The three models of the WallFlex Biliary RX Stenting System: fully covered, partially covered and uncovered, are now available in both the the US and Europe.

The WallFlex Biliary RX Stent is designed to offer the benefits of prior-generation stents, such as WallStent Endoprosthesis. The WallFlex Biliary RX Stent employs a platinum-cored Nitinol construction designed to deliver on three critical components: radial force, flexibility and radiopacity based on extensive research and physician feedback.

The company said that to allow more precise stent placement the full-length radiopacity of the Platinol Wire and the reconstrainable delivery system are designed. RX Stent is designed to maintain patency and resist migration the radial force of the WallFlex Biliary.

Moreover, to resist tissue ingrowth, theWallFlex Biliary RX Stents also feature a closed-cell construction, looped ends intended to reduce the risk of tissue trauma, and flared ends to help reduce the risk of stent migration.

Additionally, durable silastic polymer (Permalume) covering of the fully and partially covered stents is designed to reduce the potential for tumor ingrowth.

Kenneth Binmoeller, an investigator for the WallFlex Biliary RX fully covered stent study, said: “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.”