May 5, 2014

Medical Device Daily

EGS: TIF dramatically eliminates GERD symptoms in most patients

CHICAGO — Gastroesophageal reflux disease (GERD) patients with incomplete symptom control even on the maximum dose of proton pump inhibitor (PPI) therapy have a new, less invasive option than surgery. EndoGastric Solutions (EGS; San Mateo, California) released new data at Digestive Disease Week (DDW) in Chicago that show most GERD patients 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, multi-center clinical trial known as TEMPO also showed that all 21 patients in the original control arm who had received maximum-dose 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, according to EGS. DDW is considered the largest gastroenterology meeting and is jointly sponsored by the American Gastroenterological Association (AGA; Bethesda, Maryland) Institute, the American Association for the Study of Liver Diseases,(AASLD; Alexandria, Virginia), the American Society for Gastrointestinal Endoscopy (ASGE; Downers Grove, Illinois), and the Society for Surgery of the Alimentary Tract.(SSAT; Beverly, Massachusetts).  The meeting kicked off Saturday and will run through Tuesday. Karim Trad, MD, principal investigator of the TEMPO study, presented the new analysis as part of an AGA research forum on earlier today at DDW. 

“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 Trad, a surgeon at George Washington University School of Medicine and Health Sciences (Washington). “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.” 

According to the new analysis, 77% of patients in the original treatment arm (39 patients) 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% (one out of 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 out of 21) six months after these patients crossed over and had the TIF procedure.

Additionally, 71% (15 out of 21) of the cross-over patients were completely off PPIs six months following the TIF procedure. This is significant data for the patient population that have an absolute need for an answer to their symptoms, Trad told Medical Device Daily.

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