EndoGastric Solutions yesterday touted the results of a study that showed its EsophyX device was effective at treating certain hiatal hernia patients who have gastroesophageal reflux disease (GERD).
The study concluded that and transoral incisionless fundoplication (TIF) using EsophyX is an effective treatment for patients with a hiatal hernia (HH) that is larger than 2 cm and contributes to GERD. It was published in the latest issue of Surgical Innovation.
The study found that among 99 patients observed for 12 months after treatment with EsophyX, symptoms of heartburn, regurgitation and difficulty swallowing had improved. GERD health-related quality of life scores improved by 19 points at six months and 17 points at 12 months. No adverse events were reported and subjects did not report common side effects that occur with the traditional surgical fundoplication (gas bloat and inability to belch or vomit).
“The results of this study, which comprised the largest patient cohort and longest follow-up time for the evaluation of HH+TIF, further confirm that the combined approach is safe and effective in addressing both aspects of the anti-reflux barrier,” said principal investigator Dr. Peter Janu, a general and vascular surgeon at Ascension Medical Group in Wisconsin, in a news release. “In addition, our data suggest that combining the two procedures and definitively addressing any hiatal defect may have a positive impact on efficacy and durability of reflux control.”
“The results of this study further support that concomitant laparoscopic HH repair and endoscopic TIF 2.0 valve reconstruction provide an effective solution for treating reflux without the adverse events associated with traditional surgical antireflux procedures,” added EndoGastric Solutions president & CEO Skip Baldino. “These findings are important because they demonstrate that a larger population of patients (those with HH >2cm) could benefit from and should be considered candidates for surgical treatment of their refractory reflux disease.”
EndoGastric Solutions’ first version of the EsophyX device won FDA clearance in 2007 and the third-generation Z model launched in 2015.