(RTTNews) - Medical device maker Boston Scientific Corp. (BSX:
News ), Friday said it received 510(k) clearance from the U.S. Food and Drug Administration and CE Mark approval to market WallFlex Fully Covered Esophageal Stent for the treatment of malignant esophageal strictures caused by tumors in patients with resectable or non-resectable esophageal cancer.
With this approval, the company said its complete portfolio of WallFlex Stent family of self-expanding metal stents is now available in U.S., Europe and other international markets
While commenting on the approval, Boston Scientific also noted that WallFlex Partially Covered Esophageal Stent was cleared by the FDA and received CE Mark in 2008.
Michael Phalen, president, Boston Scientific Endoscopy said, "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."
TheWallFlex Esophageal Stent is indicated enabling physicians to remove obstructions of the esophagus reestablishing oral intake of patients, there by increasing life expectancy of patients.
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.
WallFlex Fully and Partially Covered Stents employ a proprietary Permalume silicone covering designed to prevent tumor ingrowth, seal concurrent esophageal strictures and help reduce food impaction.
Drew Schembre, chief of Gastroenterology at Virginia Mason Medical Center in Seattle, Washington said, "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."
Hands-on demonstration of both Stents are indicated to occur during Gastro 2009 conference, scheduled to take place from November 21-25 in London.
BSX is currently trading at $8.14, down $0.07 or 0.85%, on the NYSE.
 | | To receive FREE breaking news email alerts for Boston Scientific Corp and others in your portfolio |
|
by RTT Staff Writer
For comments and feedback: contact editorial@rttnews.com