Positive six-month results were maintained a year after TIF procedure; all control patients crossed over to receive TIF procedure and achieved similar results to original treatment group
Data Presented at DDW® 2014
CHICAGO (May 5, 2014)—EndoGastric Solutions® (EGS), a leader in endoluminal reconstructive treatment for gastroesophageal reflux disease (GERD), today announced that new data show that a vast majority of patients with GERD who underwent the Transoral Incisionless Fundoplication (TIF®) procedure with the EsophyX® device continued to report complete elimination of all troublesome regurgitation and esophagitis for a full year after the procedure.
This new 12-month analysis of the prospective, randomized, multicenter clinical trial known as TEMPO also showed that all 21 patients in the original control arm who had received maximum-dose proton pump inhibitor (PPI) therapy for the first six months of the trial crossed over to undergo the TIF procedure. This group achieved similar positive six-month results to the patients in the original treatment arm.
The new 12-month analysis was presented by principal investigator, Karim S. Trad, MD, as part of an American Gastroenterological Association (AGA) research forum earlier today at Digestive Disease Week® (DDW®) 2014 (Abstract #724), taking place here through May 6.
“This study confirms that in well-selected GERD patients with incomplete symptom control on high-dose PPI therapy, the TIF procedure is capable of dramatically and durably eliminating GERD symptoms, healing esophagitis and improving quality of life,” said Dr. Trad, a surgeon at George Washington University School of Medicine and Health Sciences who reported on the 12 months follow-up data at DDW. “This incisionless, endoluminal approach offers a subgroup of patients who are dissatisfied with PPIs a less invasive option than current surgical approaches, with minimal or no side-effects. We are planning to follow our study patients for up to three years.”
Seventy-seven percent of patients in original treatment arm (n-39) reported a global elimination of daily troublesome regurgitation and atypical symptoms 12 months following the TIF procedure. Esophagatis, or inflammation of the esophagus, remained healed in 100% of the patients in the original treatment arm.
At the end of the first six months of the study, only 5% (1/21) of patients in the control group who received maximum-dose PPI therapy reported global elimination of regurgitation and atypical symptoms; this proportion increased to 67% (14/21) six months after these patients crossed over and had the TIF procedure (P < 0.001). Additionally, 71% (15/21) of the cross-over patients were completely off PPIs six months following the TIF procedure.
“These results add to the growing body of Tier-1 clinical data supporting use of the TIF procedure as an important therapeutic option for many long-term GERD sufferers, particularly those who no longer respond to drug therapy, but aren’t prepared for the risk and recovery time of traditional open or laparoscopic surgery,” said Skip Baldino, President and CEO of EGS.
“The presentation of the one-year outcomes from this important study represents one of the most important clinical milestones for EGS and the entire endoluminal procedure category to date. This is just one of many presentations and publications we expect during 2014. I believe this evidence will have a substantial impact on the utilization of and reimbursement for endoluminal approaches for GERD – and is one of the key reasons why I wanted to join EGS at this time,” continued Baldino.
The primary outcome of TIF® versus Medical PPI Management of Refractory GERD symptoms (TEMPO) trial was elimination of daily troublesome regurgitation and atypical symptoms as evaluated by two validated instruments—Reflux Disease Questionnaire and Reflux Symptom Index; secondary outcomes included healing of esophagitis, normalization of esophageal acid exposure and PPI use in the TIF treated patients at 6 and 12 months.
This TEMPO data presented at the American Gastroenterological Association’s session GERD: Complications and Extraesophageal Presentations at the 2014 DDW® Annual Meeting in Chicago, Illinois include results from 63 patients treated at seven U.S. centers, including three gastroenterology practices and four general surgery practices.
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 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. 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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