|One of Boston Scientific's line of Wallflex esophageal stents won a CE mark.--Courtesy of Boston Scientific|
Boston Scientific ($BSX) nabbed a new CE mark that allows one of its esophageal stents to be used to treat narrowing of the esophagus caused by benign scar tissue--another win as the company seeks to restore steady revenue expansion after a years-long slump.
Previously, the WallFlex Fully Covered Esophageal Stent earned a CE mark and U.S. FDA approval to alleviate pain caused by malignant esophageal growths. While Boston Scientific doesn't have the expanded indication in the U.S., the European Union regulatory nod still helps the company expand the product's long-term revenue potential. On a wider scale, expanded approval for existing products is also part of the Massachusetts device company's multifaceted strategy to restore steady revenue growth. That focus has also included acquisitions and a slew of new product approvals.
Boston Scientific said its WallFlex fully covered esophageal stent features a silicone coating designed to prevent tumor in-growth. It's designed to be expanded gradually over the course of 24 to 72 hours as a treatment for what are formally known as refractory benign esophageal strictures. Additionally, it includes a Teflon-coated polyester suture that allows it to be removed for up to 8 weeks, something the company said can save patients from having to hit the hospital for additional procedures.
David Pierce, president of Boston Scientific's endoscopy arm, said in a statement that the expanded indication will give European Union physicians expanded treatment options for patients who suffer from benign esophageal strictures.
Of course, Boston Scientific isn't alone in the field by any means. Among its competitors: Cook Medical, which began testing whether it's possible to remove a self-expanding metal esophageal stent after its job is done. Esophageal stents are typically placed permanently to treat conditions relating to esophageal cancer and other related blockages and conditions. The Cook Medical study, announced last December, is expected to enroll up to 130 patients at as many as 15 U.S. sites.
Last May, Boston Scientific enrolled the first patient in a study of a related product--its self-expanding WallFlex Biliary RX Stent, with a goal of broadening the indication to drain bile before pancreatic cancer surgery. It had previously obtained FDA and CE mark approval status to treat pain and discomfort related to the disease for up to a year.
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