TEMPO Study Level 1 Data Directly Comparing Transoral Incisionless Fundoplication (TIF) Procedure to PPI Use Presented at DDW® 2013
Redwood City, CA (May 21, 2013)–EndoGastric Solutions® (EGS), the leader in endoluminal reconstructive treatment for gastroesophageal reflux disease (GERD), today announced new data from a prospective, randomized, controlled trial show that patients with GERD who underwent Transoral Incisionless Fundoplication (TIF®) procedures with the EsophyX® device experienced significantly better outcomes in reduction of troublesome GERD symptoms after six months than patients who continued to take maximum daily doses of proton pump inhibitor (PPI) medications for that time period.
In this study, Transoral Incisionless Fundoplication (TIF) was superior to maximal PPI dose in elimination of daily troublesome typical and atypical chronic GERD symptoms such as heartburn, regurgitation, globus sensation, hoarseness and cough at 6-month follow-up.
Daily bothersome heartburn was eliminated in 90% of patients in the TIF group versus only 13% in the PPI group. Furthermore, 90% of patients in the TIF group completely ceased PPI use. Both groups achieved similar normalization of distal esophageal acid exposure (54% of patients in the TIF group and 52% of patients in the PPI group). There was no difference between treatment groups in the clinical characterizations of the disease at baseline.
Karim S. Trad, MD, surgeon at George Washington University School of Medicine and Health Sciences, principal investigator of the TIF® versus Medical PPI Management of Refractory GERD symptoms (TEMPO) trial, presented the first six month data from the study during the American Gastroenterological Association’s Late-breaking abstract session at the 2013 DDW® Annual Meeting in Orlando, Florida.
“This randomized controlled study establishes for the first time that, for some patients, the TIF procedure is better than maximal dose PPI therapy in controlling a whole range of GERD symptoms,” said Dr. Trad. “Going forward, TIF should be offered as an alternative to the right patients who are not completely responsive to PPIs, or who are seeking to avoid the long-term side effects of medications”.
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. Patients implement these recommendations in an effort to manage their symptoms and, for many; quality of life becomes negatively impacted over time.
“The TIF procedure’s primary objective is to address failed anatomy in order to augment the body’s natural barrier and protect the esophagus from normal stomach chemistry,” said Mike Kleine, President and CEO of EGS. “Using drugs to artificially neutralize stomach acid for prolonged periods has to be problematic – stomach acid has an important role in normal GI function. A successful outcome for us is to normalize a patient’s life as much as possible.”
The TEMPO data include results from 63 patients treated at seven U.S. centers, including three gastroenterology practices and four general surgery practices. TEMPO was designed to assess the safety and efficacy of the TIF procedure as compared with high-dose PPI therapy to treat symptoms associated with chronic GERD. Patients will continue to be followed until they have completed 12-, 24-, and 36-month follow-up.
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 secrete large amounts 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.
About EsophyX® 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. TIF is a surgical solution that corrects the root cause of Gastroesophageal Reflux Disease (GERD), a disease that affects over 60 million people in the U.S. The TIF procedure is based on traditional surgical principles and is minimally invasive and offers similar effectiveness to a surgical repair with the safety profile of a transoral approach. To date, more than 10,000 patients have been treated worldwide. For more information, visit www.GERDHelp.com.
About EndoGastric Solutions®
EndoGastric Solutions, Inc. (www.endogastricsolutions.com), headquartered in Redwood City, California, is a leader in the endoluminal treatment of digestive diseases. EGS’ mission is to utilize the most current wisdom in gastroenterology and surgery to develop procedures and products that address unmet needs in gastrointestinal diseases.
About Digestive Disease Week® (DDW®)
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 18 – 21, 2013, at the Orange County Convention Center, Orlando, FL. 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.
EndoGastric Solutions, Inc.