We had earlier reported that Boston Scientific had received an FDA approval for their WallFlex Biliary RX fully and partially covered stents for the palliative treatment of malignant bile duct strictures. The company recently also received the FDA clearance for promoting its WallFlex Fully Covered Esophageal Stent in the treatment of malignant esophageal strictures caused by tumors in patients suffering from resectable or non-resectable esophageal cancer.
Patients with blockages owing to esophageal cancer could have trouble in swallowing, thereby ensuing in acutely restricted quality of life. Total obstructions of the esophagus may avert liquid consumption. The WallFlex Esophageal Stent enables physicians to restore patency of the esophagus, thus facilitating continuation of oral intake.
“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. Moreover, the fully covered option may be a viable choice for patients with operable esophageal cancer who are undergoing chemotherapy and radiation treatment in preparation for surgery,†commented Drew Schembre, M.D., Chief of Gastroenterology at Virginia Mason Medical Center in Seattle, Washington.
Michael Phalen, President, Boston Scientific Endoscopy, remarked, “The availability of the complete line of WallFlex Fully and Partially Covered Esophageal Stents represents a tremendous milestone for Boston Scien. This advanced line of esophageal stents is designed to improve the quality of life for the thousands of patients suffering from esophageal cancer. We are pleased that our entire WallFlex Stent family — biliary, enteral and now esophageal — is available in the U.S., Europe and other strategic international markets. This underscores our mission to meet the high expectations of our customers and deliver a complete range of innovative treatment options to diagnose, palliate and treat patients with diseases of the gastrointestinal tract.â€
The WallFlex Fully and Partially Covered Stents use a proprietary Permalume silicone casing intended to avert tumor ingrowth, seal concurrent esophageal fistulas and aid in decreasing food impaction. The stents’ progressive-step, flared ends are planned in such a way so as to cut down the possibility of migration and may help in fastening the entirely enclosed stent inside the esophageal lumen.
The numerous wire-braided constructions are engineered to let the stent adapt to forces in the esophagus like peristalsis and strictures. Moreover, the WallFlex Fully Covered Stent could be reconstrained up to 75 percent deployment.
The WallFlex Partially Covered Esophageal Stent was approved by the FDA and was given CE Mark in 2008. Both stents along with the complete WallFlex Stent family of self-expanding metal stents (SEMS) will be accessible for practical display at the GASTRO 2009 conference.