Healthcare Industry News:  osteoporosis 

Devices Interventional Gastroenterology

 News Release - February 26, 2008

EndoGastric Solutions(TM) Announces Results of EsophyX(TM) Multi-Center GERD Study

85% of patients remain symptom-free and off daily GERD medication at 1 year after transoral incisionless fundoplication surgery

REDMOND, Wash., Feb. 26 (HSMN NewsFeed) -- EndoGastric Solutions, the world leader in natural orifice surgery products and procedures, announces outstanding results at the completion of 1-year follow-up on GERD patients in the phase 2 multi-center study of the first generation transoral incisionless fundoplication (TIF 1) procedure and first-generation EsophyX device. EndoGastric Solutions is the first company to successfully design truly incisionless transoral surgical products that mimic the outcomes of the more invasive gold-standard antireflux surgeries, laparoscopic fundoplications (i.e. Nissen, Toupet or Hill procedures). The EsophyX device enables surgeons and advanced interventional gastroenterologists to offer their patients substantive anatomical repair without incisions (no skin or internal dissection) for front-line surgical management of gastroesophageal reflux disease (GERD) patients.

Dr. John Hunter, Professor and Chairman of the Department of Surgery at Oregon Health & Science University in Portland, Oregon, states, "For years, the medical community has been looking for less invasive ways to treat GERD patients to reduce their dependence on pharmaceuticals. Our department has studied the effects of these pharmaceuticals and is concerned that there are additional detrimental effects that should be avoided. EsophyX is an impressive technology with impressive results that advances the treatment of GERD a giant leap forward."

Dr. Todd Overcash, Medical Director of Bariatric and Minimally Invasive Surgery at Munroe Regional Medical Center in Ocala, Florida, is the United States leader of NOS (Natural Orifice Surgery) procedures performed. He was among the first U.S. surgical teams that went to Europe last fall to train on this new technique. He has now performed more EsophyX procedures than any surgeon in the U.S. and states: "Having performed 38 advanced TIF procedures with the EsophyX device in the last three months, I can attest that this incisionless technique offers our patients a tremendous improvement in their quality of life. It allows them the ability to eat foods and beverages they could not tolerate before the procedure but, most importantly, it allows them to discontinue their use of GERD medications in the majority of cases, which is especially important for women in the face of osteoporosis. With no skin incisions, no cutting of vessels, and no dissection of the fundus, the EsophyX device represents a new era in antireflux treatment and offers patients an innovative, state-of-the-art surgical procedure that will allow them to no longer live their lives pill-to-pill."

Dr. Scott Melvin, Professor of Surgery, Director of the Center for Minimally Invasive Surgery and Chief of the Division of General & Gastrointestinal Surgery at The Ohio State University (OSU) Medical Center, will be demonstrating this new TIF technique at a live case course at OSU February 29th: "I am very impressed with the clinical results for EsophyX, including the reduction/elimination of hiatal hernia and reduction/elimination of esophagitis. These multi-center study results confirm the 2 year outcomes seen in the first EsophyX study. With over 750 Natural Orifice Surgical cases performed to date, utilizing EndoGastric Solutions technology platforms, it is clear that TIF is a mainstream procedure that most advanced foregut surgeons should be incorporating into their clinical practice. Any surgeon considering being a natural orifice surgeon should come see the techniques and learn more at our course."

"We are very pleased with the outstanding results of our first two GERD clinical studies," states Thierry Thaure, CEO of EndoGastric Solutions (EGS) Inc. "These results were achieved with the first version of the EsophyX device and TIF 1 procedure. We believe in continuous improvement and are already teaching a much improved TIF 2 technique in our training center in Redmond, Washington that has shown even stronger outcomes. We are encouraged that surgeons and advanced surgical endoscopists are rapidly adopting these new incisionless procedures, as patients are demanding a permanent solution for their reflux disease in the face of failing pharmacological therapy."

About EndoGastric Solutions

EndoGastric Solutions (EGS) is a privately held corporation located in Redmond, Washington and Redwood City, California. EGS is a pioneer in developing incisionless transoral procedures for the treatment of upper gastrointestinal diseases, including gastroesophageal reflux disease (GERD) and other GI conditions. EsophyX and StomaphyX(TM) are cleared by the FDA for specific indications, are CE marked, and are available for sale in the U.S. and Europe.

For more information about EndoGastric Solutions, Inc., EsophyX(TM) and StomaphyX(TM), please visit:

US: http://www.endogastricsolutions.com
EU: http://www.egseurope.eu
Other locations: http://www.egsglobal.net

For more information about the Ohio State University Medical Center Leap into the Future with Advances in Transoral Foregut Surgery course please visit: http://www.cmis.ohio-state.edu


Source: EndoGastric Solutions

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