EU Approves Boston Scientific Stent for Esophageal Strictures

Natick, Mass.-based medical device maker Boston Scientific Corporation has earned the CE mark from the European Union for its Wallflex esophageal fully covered stent to treat refractory benign esophageal strictures.

Benign esophageal strictures are a narrowing of the esophagus caused by scar tissue. The primary treatment is dilation of the esophagus, which may need to be repeated after a period of time if the stricture recurs.

“Fully covered esophageal stents are a valid therapeutic option in patients with benign refractory esophageal strictures,” said Javier Jimenez, M.D., chief of the endoscopy department at Complejo Hospitalario de Navarra in Pamplona, Spain. “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.”

“The advantage of the Wallflex esophageal fully covered stent is its ease of use and now removability, which allows me to treat patients with refractory benign strictures,” said Peter D. Siersema, M.D., Ph.D., professor of gastroenterology and head of the department of gastroenterology and hepatology at University Medical Center in Utrecht, The Netherlands.

The nitinol wire braided construction is designed to allow the Wallflex esophageal stent to provide luminal patency in the presence of strictures or tumors. The stent is designed for gradual expansion, typically complete after 24 to 72 hours, and features a Permalume silicone coating intended to prevent tumor in-growth, seal concurrent esophageal fistulas and help reduce food impaction. 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. The Wallflex stent also reportedly provides physicians with clear visualization during fluoroscopy, aiding in accurate placement. The progressive step flared ends assist in anchoring the stent within the esophageal lumen.

“Building on the best of Boston Scientific’s industry-leading stents, the expanded indication for the WallFlex esophageal fully covered stent demonstrates our commitment to physician needs and dedication to improving patient outcomes,” said David Pierce, president of endoscopy at Boston Scientific. “This enables physicians in the European Union to provide additional options for the treatment and management of patients suffering from benign esophageal strictures.”

Both fully covered and partially covered Walflex esophageal stents have previously received CE mark and U.S. Food and Drug Administration 510(k) clearance for the palliative treatment of malignant esophageal strictures. The stents are not approved for removal from malignant strictures and are not approved in the United STates for the treatment of refractory benign esophageal strictures.