Highlights include the presentation of 12-month follow-up data from first randomized controlled trial of Transoral Incisionless Fundoplication (TIF®) procedure with the EsophyX® device
SAN MATEO, Calif. (April 28, 2014) EndoGastric Solutions® (EGS), the leader in endoluminal reconstructive treatment for gastroesophageal reflux disease (GERD), today announced that the first 12-month follow up data from a prospective, controlled study of Transoral Incisionless Fundoplication (TIF®) procedure with the EsophyX® device will be presented at Digestive Disease Week® (DDW) 2014.
On Monday, May 5 at 2:30 p.m. CT, Karim S. Trad, MD, a surgeon at George Washington University School of Medicine and Health Sciences, will present the 12-month follow-up data from the TIF® versus Medical PPI Management of Refractory GERD symptoms (TEMPO) study.
The presentation (Abstract #724) is part of an American Gastroenterological Association (AGA) research forum session, “GERD: Complications and Extraesophageal Presentations,” which will take place in room S106B.
The TEMPO data includes 12-month outcomes from 63 randomized and cross-over patients treated at seven U.S. centers, including three gastroenterology practices and four general surgery practices.
The TEMPO trial was designed to assess the safety and efficacy of the Transoral Incisionless Fundoplication procedure as compared with high-dose PPI therapy to treat symptoms associated with chronic GERD.
The TEMPO investigators will be available for an additional question and answer session on Tuesday May 6 at 9:30-10:30 AM at the EGS DDW Booth #3128.
|TIF Procedure Research and Educational Highlights at DDW:|
|Latest published data and new patient stories.||Sunday, May 4 to Tuesday, May 6
9:30 a.m. – 4:00 p.m. CT
|EGS DDW Booth #3128|
|American Gastroenterological Association’s Clinical Symposium Different Faces of GERD in 2014||Sunday, May 4, 10:00 – 11:30 AM||Room S502|
|American Society of Gastrointestinal Endoscopy’s Learning Center Endoscopic Hands-on Demonstration Session||Sunday, May 4
10:30 a.m. – 12:30 p.m. CT
|American Gastroenterological Association’s session GERD: Complications and Extraesophageal Presentations||Monday, May 5 2:30 – 2:45 PM||S106B|
|Q&A with TEMPO study investigators including Karim Trad, MD, principal investigator||Tuesday, May 6
|EGS DDW Booth #3128|
EndoGastric Solutions did not provide financial support for the following scientific sessions and did not influence the content in any way. However, research presented within these scientific sessions may have been supported by EndoGastric Solutions.
Gastroesophageal Reflux Disease (GERD) is a condition caused by anatomical changes where the muscle at the base of the esophagus relaxes between swallows, allowing corrosive stomach acid to wash back up into the esophagus. The stomach produces hydrochloric acid after a meal to aid in the digestion of food. The cells that line the stomach consists of protective mucus that protect it from erosion, but the lining of the esophagus does not share these resistant features and stomach acid can damage it.
GERD is the most common gastrointestinal-related diagnosis given by physicians during clinical visits in the U.S. It is estimated that pain and discomfort from acid reflux impacts over 23 million people two or more times per week in the U.S. The standard recommendations for symptomatic GERD patients include lifestyle changes (e.g. diet, scheduled eating times, and sleeping positions) and escalating doses of prescription medications for prolonged periods of time. Long-term, maximum dose usage of prescription medications has been linked to a variety of other health complications. Over months or years, patients implement these recommendations attempting to manage their symptoms and the quality of their lives becomes negatively impacted.
About EsophyX2® and Transoral Incisionless Fundoplication TIF®)
The EsophyX device was FDA cleared in 2007, and is commercially available in the United States. Inserted transorally with visual guidance from an endoscope, the EsophyX device is used in the TIF procedure to reconstruct the gastroesophageal valve (GEV), restoring its competency and reestablishing the barrier to reflux. The TIF procedure is a surgical solution that corrects the root cause of Gastroesophageal Reflux Disease (GERD). The TIF procedure is based on traditional surgical principles and offers similar effectiveness to a surgical repair with the safety profile of an incision-free approach. To date, more than 15,000 patients have been treated worldwide. For more information, visit www.GERDHelp.com.
About EndoGastric Solutions®
EndoGastric Solutions, Inc. (www.endogastricsolutions.com), headquartered in San Mateo, California, is a leader in the endoluminal treatment of digestive diseases. EGS’ mission is to combine the most advanced concepts in gastroenterology and surgery to develop products and procedures that address unmet needs in gastrointestinal diseases.
About Digestive Disease Week® (DDW)®
Digestive Disease Week® (DDW®) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 3 – 6, 2014, at McCormick Place, Chicago, IL. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.
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