The EsophyX technology is used to reconstruct the gastroesophageal valve (GEV) and restore its function as a barrier, preventing stomach acids from refluxing back into the esophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope, and enables creation of a 3 cm, 270° esophagogastric fundoplication. The U.S. Food and Drug Administration cleared the original EsophyX device in 2007. The evolving technology, including the latest iteration EsophyX Z+, launched in 2017, enables surgeons and gastroenterologists to use a wide selection of endoscopes to treat the underlying anatomical cause of GERD.
The publication of new clinical data demonstrating high rates of pH normalization and improved clinical outcomes in patients with gastroesophageal reflux disease (GERD) undergoing laparoscopic hiatal hernia repair followed by the Transoral Incisionless Fundoplication (TIF® 2.0 procedure) was announced today by EndoGastric Solutions. The TIF 2.0 procedure is a minimally invasive endoscopic intervention performed with the EsophyX® device that enables anatomic correction of the gastroesophageal valve without the resulting complications associated with traditional fundoplication. The retrospective data are reported in a paper titled “pH Scores in Hiatal Repair with Transoral Incisionless Fundoplication,” and appear in the January – March 2019 issue of the Journal of the Society of Laparoendoscopic Surgeons.1
Hiatal defects are common in GERD patients. In 2016, the U.S. Food and Drug Administration granted EndoGastric Solutions clearance to expand the EsophyX device’s indications for use to include patients with a hiatal defect greater than 2 cm when it is surgically corrected just prior to TIF 2.0 procedure.2
“This is the first study to demonstrate that a concomitant hiatal hernia repair and TIF 2.0 procedure yields statistically significant improvements in pH exposure, an objective measurement in the treatment of GERD,” said Glenn Ihde, MD, a board-certified general surgeon at the Matagorda Medical Group in Bay City, Texas, and lead author of the publication. “Significantly, pH scores were normalized in 95 percent of patients with intact hiatal repair at follow-up assessment. This patient group also experienced a decrease in bloating syndrome related to traditional laparoscopic fundoplication. These promising results warrant further evaluation in additional prospective studies of this set of concomitant procedures.”
The new study is a retrospective analysis of 97 GERD patients evaluated between October 2015 and December 2017 with mean follow-up evaluation at 296 days. Patients in the study experienced heartburn and/or regurgitation and had a history of proton pump inhibitor (PPI) use that averaged 8 years. All patients had positive indications of GERD, 55 of the 97 patients proceeded to hiatal hernia repair with concomitant TIF 2.0 procedure. Of these 55 patients, 29 (53%) had matched pre- and post-operative assessments. Key findings among these 29 patients include:
· Twenty-two of the 29 patients had intact hiatal hernia and TIF procedure repairs.
· Of the 22 intact repairs, 21 patients showed normalization of pH scores (95%).
· A significant improvement in average pH scores from baseline of 35.3 to 10.9 at follow-up (p<0.01).
· A significant improvement in average GERD health-related quality-of-life (HRQL) scores from baseline 33.75 to 9.07 at follow-up (p<0.01).
· A significant improvement in average Reflux Symptom Index (RSI) scores from baseline of 20.32 to 8.07 at follow-up (p<0.01).
· There were no serious adverse events.
“These findings support the safety and efficacy of concomitant hernia repair and TIF 2.0 procedure with the EsophyX device,” said Skip Baldino, President and CEO of EndoGastric Solutions. “This is an important advance for patients with hiatal defects of two centimeters or more, as the data show improved objective and subjective assessments of GERD symptoms. We look forward to additional prospective studies to provide physicians with additional data surrounding improved outcomes for their patients utilizing this approach.”
1 Ihde GM, Pena C, Scitern C, Brewer S. pH Scores in Hiatal Repair with Transoral Incisionless Fundoplication. JSLS. 2019;23(1):e2018.00087
2 Ihde GM, Besancon K, Deljkich E. Short-term safety and symptomatic outcomes of transoral incisionless fundoplication with or without hiatal hernia repair in patients with chronic gastroesophageal reflux disease. Am J Surg. 2011; 202(6):740-7.