Boston's WallFlex stent hits US and Europe
This article was originally published in Clinica
WallFlex, a fully-covered oesophageal stent developed by Boston Scientific, has been granted 510(k) clearance from the US FDA. The Natick, Massachusetts firm has also CE marked the device for sale in Europe. It is intended for the treatment of oesophageal obstructions caused by tumours in patients with oesophageal cancer. A partially covered version of the stent was cleared by the FDA and CE marked last year. The WallFlex devices employ a silicone covering called Permalume, which is designed to prevent tumour ingrowth, seal concurrent oesophageal fistulas and help reduce food impaction. Boston says that its entire WallFlex product line – biliary, enteral and oesophageal – is now available in the US, Europe and other strategic international markets.
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