Boston Scientific announces FDA clearance and CE mark for WallFlex fully covered oesophageal stent


Complete portfolio of the company’s WallFlex stent family of self-expanding metal stents now available in US, Europe and other international markets.

Boston Scientific Corporation today announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) and CE Mark approval to market its WallFlex fully covered oesophageal stent for the treatment of malignant esophageal strictures (obstructions) caused by tumours in patients with resectable or non-resectable oesophageal cancer. The WallFlex partially covered oesophageal stent was cleared by the FDA and received CE Mark in 2008. Both stents – along with the complete WallFlex stent family of self-expanding metal stents – will be available for hands-on demonstration at the GASTRO 2009 conference, which is being held November 21-25 in London.

“The low profile delivery system (18.5 Fr) of the WallFlex Esophageal Stents has allowed me to traverse tight strictures, facilitating stent placement within malignancies that, in the past, needed to be pre-dilated,” said Drew Schembre, Chief of Gastroenterology at Virginia Mason Medical Center in Seattle, Washington. “Moreover, the fully covered option may be a viable choice for patients with operable oesophageal cancer who are undergoing chemotherapy and radiation treatment in preparation for surgery.”

Patients with obstructions due to esophageal cancer may have difficulty swallowing, resulting in severely limited quality of life. Complete blockages of the esophagus can prevent liquid consumption. The WallFlex Esophageal Stent allows physicians to re-establish patency (openness) of the oesophagus, enabling resumption of oral intake.

The WallFlex fully and partially covered stents employ a proprietary Permalume silicone covering designed to prevent tumour ingrowth, seal concurrent oesophageal fistulas and help reduce food impaction. The stents’ progressive-step, flared ends are designed to reduce the risk of migration and may assist in anchoring the fully covered stent within the esophageal lumen. The multiple wire-braided construction is engineered to allow the stent to adjust to forces within the esophagus such as peristalsis and strictures. In addition, the WallFlex fully covered stent may be reconstrained up to 75 per cent deployment.