US-based Boston Scientific has received CE Mark in Europe for its WallFlex esophageal fully covered stent, designed to treat refractory benign esophageal strictures, a narrowing of the esophagus caused by scar tissue.
The WallFlex esophageal fully covered stent uses a proprietary Permalume silicone covering to prevent tumour ingrowth, seal concurrent esophageal fistulas and helps reduce food impaction.
The stent is designed for gradual expansion, typically complete after 24 to 72 hours and its progressive-step, flared ends are intended to minimise the risk of migration and may assist in anchoring the fully covered stent within the esophageal lumen.
The Nitinol wire braided construction allows the WallFlex esophageal stent to provide luminal patency in the presence of strictures or tumours.
The stent also provides physicians with clear visualisation during fluoroscopy, aiding in accurate placement.
An additional feature is a Teflon-coated polyester suture that enables removal from refractory benign strictures for up to eight weeks, potentially saving patients from having to visit the hospital to undergo additional dilations to treat their stricture.
Complejo Hospitalario de Navarra endoscopy department chief Dr Javier Jimenez in Pamplona, Spain, said: "I use the WallFlex Esophageal Stent because its small profile and radiopacity facilitate accurate placement, the migration rate is low and stent removal is usually easy."
Both fully covered and partially covered WallFlex esophageal stents have previously received CE Mark and US Food and Drug Administration (FDA) clearance for the palliative treatment of malignant esophageal strictures.
WallFlex esophageal stents are not approved for removal from malignant strictures and are not approved in the US for the treatment of refractory benign esophageal strictures.
Boston Scientific endoscopy president David Pierce said: "This enables physicians in the European Union to provide additional options for the treatment and management of patients suffering from benign esophageal strictures."
According to GlobalData estimates, the peripheral vascular stents market in Europe was valued at $271.6m in 2012 and is expected to grow at a CAGR of 3.8% to reach $351.9m by 2019.
Image: Boston Scientific's WallFlex fully covered esophageal stent. Photo: courtesy of PR Newswire/Boston Scientific Corporation.