US FDA clears Boston Scientific's fully covered oesophageal stent
21 Nov 2009
US medical devices maker Boston Scientific yesterday 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 Esophageal Stent for the treatment of malignant esophageal strictures (obstructions) caused by tumors in patients with resectable or non-resectable esophageal cancer.
The WallFlex Partially Covered Esophageal 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 (SEMS) - 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, M.D., 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 esophageal 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 esophagus, enabling resumption of oral intake.
The WallFlex Fully and Partially Covered Stents employ a proprietary Permalume silicone covering designed to prevent tumor ingrowth, seal concurrent esophageal 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 (involuntary contractions) and strictures. In addition, the WallFlex Fully Covered Stent may be reconstrained up to 75 percent deployment.
"The availability of the complete line of WallFlex Fully and Partially Covered Esophageal Stents represents a tremendous milestone for Boston Scientific," said Michael Phalen, President, Boston Scientific Endoscopy.
"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 US, 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."