EndoGastric Solutions® (EGS) has 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. Abstract is available here.
"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.
About GERD
Gastroesophageal Reflux Disease (GERD) is a chronic condition in which the gastroesophageal valve (GEV) allows gastric contents to wash back up into the esophagus, causing heartburn and possible injury to the esophageal lining. The stomach produces hydrochloric acid and other digestive enzymes after a meal to aid in the digestion of food. The cells that line the stomach compose a protective mucus that can withstand gastric contents, while the cells that line the esophagus lack the same protection.
GERD is the most common gastrointestinal-related diagnosis made 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.
About the EsophyX® device
The EsophyX device was FDA cleared in 2007, and is commercially available in the United States. Inserted through the patient's mouth with visual guidance from an endoscope, the EsophyX device is used to reconstruct the gastroesophageal valve (GEV) in order to restore its function as a barrier to prevent stomach acids from washing back up into the esophagus.
About Transoral Incisionless Fundoplication (TIF®) procedure for reflux
Performed entirely through the mouth without the need for external incisions through the skin, the TIF procedure offers patients who require an anatomical change to correct the underlying cause of GERD, another treatment option beyond traditional surgery. Studies show that for up to three years after the TIF procedure esophageal inflammation (esophagitis) is eliminated and most patients are able to stop using daily PPI medications to control symptoms.
The TIF procedure has an established safety and efficacy profile with more than 16,000 patients treated worldwide. For more information, visit www.GERDHelp.com.