Quality-of-Life Survey Scores on Medications and Presence of Esophagitis Appear to Be Best Correlated Predictors of Success
SAN MATEO, Calif. (June 9, 2014)–EndoGastric Solutions® (EGS), a leader in endoluminal reconstructive treatment for gastroesophageal reflux disease (GERD), announced publication of US registry data on patient factors predictive of positive outcomes following transoral incisionless fundoplication (TIF). The study demonstrates that patients with an objective diagnosis of GERD who experience persistent typical symptoms while taking proton pump inhibitor (PPI) medication are likely to respond favorably to the TIF procedure.
In this study, presence of esophagitis—inflammation of the esophagus—objectively confirmed a diagnosis of GERD. Persistent typical symptoms of GERD were measured by several validated surveys; however, a GERD-HRQL score of ≥ 15 while on PPIs was found to be a positive predictor for a successful outcome from a TIF procedure.
This new data has been published online in the journal Surgical Endoscopy; abstract is available here.
“GERD is a very common condition. Many patients do not respond adequately to medical therapy and seek minimally invasive treatment options” said Reginald Bell, MD, general surgeon at SurgOne Foregut Institute in Englewood, CO. and primary author on the paper. “This data helps physicians identify patients with troublesome reflux symptoms who are most likely to have a successful outcome following the TIF procedure.”
The analysis includes results from 158 consecutive patients who underwent the TIF procedure at 14 U.S. centers, including 13 general surgery practices and one gastroenterology practice. The study was designed to assess the impact of the TIF procedure on patients with chronic GERD. Follow-up is ongoing for the registry study patient population; the median follow-up for this analysis was 22 (range 10-43) months.
“The data informs clinical practice by shedding light on proper patient selection and adds to the existing body of evidence on TIF,” said Skip Baldino, EGS President and CEO. “The data should provide additional insights on proper patient selection and could be used to define specific patients that are most likely to benefit from our technology.”
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.
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.
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.
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 15,000 patients 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.
Contacts:
Josh DeFonzo
EndoGastric Solutions, Inc.
Phone: 650-578-5120
jdefonzo[at]endogastricsolutions[dot]com
Hollister Hovey
Lazar Partners, LTD
Phone: 646-871-8482 (direct)
hhovey[at]lazarpartners[dot]com
Twitter: @GERDHelp
Facebook: GERDHelpcom
Google+: GERDHelp
The EsophyX device with SerosaFuse fasteners is indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia < 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease.
