Boston Scientific receives new EU approval for WallFlex oesophageal stent

Boston Scientific has been granted European CE Mark approval for a new device for its WallFlex Oesophageal Fully Covered Stent in a new indication.

The fully-covered metal stent has been approved for the treatment of refractory benign oesophageal strictures, a narrowing of the oesophagus caused by scar tissue. The primary treatment of this condition is dilation of the oesophagus, which may need to be repeated after a period of time.

Boston Scientific's new device features a Nitinol wire braided construction that allows the device to provide luminal patency in the presence of strictures or tumours.

Other benefits include the fact it is designed for gradual expansion, typically complete after 24 to 72 hours and features a Permalume silicone coating to prevent tumour in-growth, seal concurrent oesophageal fistulas and reduce food impaction. 

David Pierce, president of endoscopy at Boston Scientific, said: "The expanded indication for the WallFlex Oesophageal Fully Covered Stent demonstrates our commitment to physician needs and dedication to improving patient outcomes."

This comes after the firm launched its new OffRoad Re-Entry Catheter System in the US earlier this month.