"Redmond, Washington - April 2, 2007 - EndoGastric Solutions, the world leader in endoluminal intragastric surgery, is pleased to announce that it has received clearance from the US FDA for its StomaphyX™ device. StomaphyX™ is indicated for use in endoluminal transoral tissue approximation and ligation in the Gastrointestinal (GI) tract.
'This is a major event in the history of our company,' said Thierry Thaure, EndoGastric Solutions’ President and Chief Executive Officer. 'StomaphyX™ is our first product cleared for commercialization in the United States and represents the first US product launch in our portfolio of endoluminal surgical products.'
So far, EndoGastric Solutions has been best known for its pioneering work in the reconstruction of the gastroesophageal valve for the treatment of GERD (GastroEsophageal Reflux Desease). EGS (EndoGastric Solutions) sponsored a multicenter trial for the ELF EsophyX™ procedure (EndoLuminal Fundoplication) for which enrollment was completed in late 2006.
'After carefully incubating our technologies and know-how, we are now evolving rapidly and delivering a portfolio of products to the market,' said Thaure. 'Our European experience, consisting of over 250 EsophyX cases, has facilitated the rapid iteration of our products and has positioned us for an imminent US corporate launch'."