US registry data shows long-term positive outcomes for GERD patients choosing TIF procedure

EndoGastric Solutions Reports Two-Year Durability Data from TIF Registry for GERD Patients Choosing Transoral Incisionless Fundoplication (TIF^®)

EndoGastric Solutions^® (EGS) announced publication of US registry data showing that long-term gastroesophageal reflux disease (GERD) sufferers who underwent an incisionless procedure maintained symptom relief without the need to take proton pump inhibitor medicines for two years.

Data from the EndoGastric Solutions^® (EGS) Transoral Incisionless Fundoplication (TIF^®) registry show that outcomes from the procedure observed at six and 12 months remained stable across a range of evaluation methodologies at 24-month follow-up. The TIF procedure reconstructs the gastroesophageal valve which has been found to be the primary cause of GERD.

“These new findings demonstrate the long-term positive outcomes that come from treating the underlying cause of GERD with this innovative, incisionless approach,” said Reginald Bell, MD, general surgeon at SurgOne Foregut Institute in Englewood, CO and lead author of the paper. “Because the side-effect profile of this procedure is almost non-existent and patients were able to remain off medical therapy, patients now have a very attractive option that fills the treatment gap between PPIs and traditional surgery.”

Patient quality of life scores, measured using a series of validated questionnaires, improved and were sustained compared to baseline at 6-, 12-, and 24-month follow-up intervals (p=<0.001). The data show that quality-of-life scores remained the same over time, suggesting durability of outcomes from 6 months post procedure to 24-month follow-up.

“EGS remains dedicated to developing safe, effective, and low-risk technologies and procedures that treat the tens of thousands of GERD patients who fall into the treatment gap between medical prescription therapy and invasive surgery,” said Skip Baldino, EGS President and CEO. “We are extremely pleased to see the patients who utilized the TIF procedure feeling so much better for so long without the need for medicines to control their symptoms. Given these long-term, real-life outcomes, we believe our TIF procedure can significantly enhance the quality of life for GERD patients.”

The results were published in the November issue of the journal American Surgeon in a study designed to assess the impact of the TIF procedure on patients with chronic GERD at 6-, 12- 24- and 36 month follow-up points. The publication reports results following TIF procedures in 127 consecutive patients prospectively enrolled in the registry and treated at 14 U.S. centers, including 13 general surgery practices and one gastroenterology practice.