EndoGastric Solutions announced new data that the majority of patients with GERD who underwent the transoral incisionless fundoplication (TIF) procedure with the EsophyX device continued to report complete elimination of regurgitation and esophagitis for a full year after the procedure. These results were presented at Digestive Disease Week in Chicago, IL.
Researchers conducted a 12-month analysis of TEMPO, a prospective, randomized, multicenter trial that assessed elimination of daily troublesome regurgitation and atypical symptoms as evaluated by 2 validated instruments. All 21 patients from the original control arm who had received maximum-dose proton pump inhibitor (PPI) therapy for the first 6 months crossed over to undergo the TIF procedure. These patients achieved similar positive 6-month results to patients in the original treatment arm.
Global elimination of daily troublesome regurgitation and atypical symptoms 12 months post-TIF was reported in 77% of patients in the original treatment arm. Esophagitis remained healed in all of the patients in the original treatment arm. Also, 71% (n=15) of the cross-over patients were completely off PPIs 6 months following the TIF procedure.
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