EndoGastric Solutions Receives FDA Clearance For First Transoral Surgical Product: StomaphyX(TM) Gets Clearance First

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Acid Reflux/GERD;  Clinical Trials / Drug Trials;  Medical Devices
Article Date: 03 Apr 2007 - 0:00 PDT

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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 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. EGS sponsored a multicenter trial for the ELF 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."

About EndoGastric Solutions, Inc.

EndoGastric Solutions(TM) is a pioneer in endoluminal procedures for the treatment of gastrointestinal diseases, including GERD and obesity. EndoGastric Solutions' mission is to utilize the most current wisdom in gastroenterology and surgery to develop new transoral procedures and products to address the largest unmet needs in gastrointestinal diseases. EndoGastric Solutions technologies involve modifying current open surgical and/or laparoscopic approaches by using transoral access instead of abdominal incisions. The company designs and manufactures single use instruments that will enable these incisionless solutions, and focuses on clinically based products for use by gastroenterologists and surgeons.

StomaphyX is available in the United States. EsophyX is not available for sale or use in the United States. Both devices are CE marked and available in the European Union.

EndoGastric Solutions, Inc.
http://www.endogastricsolutions.com