EndoGastric Solutions Announces 12-Month Registry Data Show Durable Elimination of Troublesome Regurgitation and Heartburn for GERD Patients Who Underwent Transoral Incisionless Fundoplication (TIF®)
Results show 74% of patients were able to stop taking and remain off proton pump inhibitor medications at 12-month follow up
SAN MATEO, Calif.--(BUSINESS WIRE)--EndoGastric Solutions® (EGS), the leader in endoluminal reconstructive treatment for Gastroesophageal Reflux Disease (GERD), today announced that data from its Transoral Incisionless Fundoplication (TIF®) registry show that outcomes from the procedure observed at 6-months remained stable across a range of evaluation methodologies at 12-month follow-up. The one-year findings showed that 78 percent of patients experienced elimination of troublesome heartburn symptoms and 83 percent stopped experiencing regurgitation. Seventy-four percent of patients completely stopped medical therapy with proton pump inhibitor medications.
“This data contributes significantly to the body of evidence that the TIF procedure is able to control troublesome symptoms of GERD patients for an extended period of time”
“This data contributes significantly to the body of evidence that the TIF procedure is able to control troublesome symptoms of GERD patients for an extended period of time,” said Erik B Wilson, MD, FACS, Professor of Surgery at University of Texas Health Science Center and the first author of the publication. “When a procedure allows patients to significantly reduce or completely eliminate their use of PPI therapy, they can avoid a range of potential harmful long-term side effects.”
The results were published in the February 2014 issue of the journal Surgical Laparoscopy Endoscopy and Percutaneous Techniques. The data show that quality-of-life scores remained the same or slightly improved over time, suggesting durability of outcomes between 6- and 12-month follow-up.
The publication reports results following TIF procedures in 100 consecutive patients enrolled in the registry and treated 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 at 12-month follow-up. Patient follow-up is ongoing for this registry study.
Gastroesophageal Reflux Disease (GERD) is a condition caused by anatomical changes where the muscle at the base of the esophagus relaxes between swallows, allowing corrosive stomach acid to wash back up into the esophagus. The stomach produces hydrochloric acid after a meal to aid in the digestion of food. The cells that line the stomach consists of protective mucus that protect it from erosion, but the lining of the esophagus does not share these resistant features and stomach acid can damage it.
GERD is the most common gastrointestinal-related diagnosis given 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. Patients implement these recommendations trying to manage their symptoms and the quality of their lives becomes negatively impacted by these recommendations.
About EsophyX® and Transoral Incisionless Fundoplication (TIF®)
The EsophyX device was FDA cleared in 2007, and is commercially available in the United States. Inserted transorally with visual guidance from an endoscope, the EsophyX device is used in the TIF procedure to reconstruct the gastroesophageal valve (GEV), restoring its competency and reestablishing the barrier to reflux. The TIF procedure is a surgical solution that corrects the root cause of Gastroesophageal Reflux Disease (GERD). The TIF procedure is based on traditional surgical principles and offers similar effectiveness to a surgical repair with the safety profile of an incision-free approach. To date, more than 15,000 patients have been 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.