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12-month data validates HH repair before TIF for GERD

Study participants saw 80 percent improvement for heartburn and regurgitation one-year post procedure when hiatal hernia and gastroesophageal valve were repaired sequentially

EndoGastric Solutions has announced the presentation of data from the Transoral Incisionless Fundoplication (TIF) 2.0 procedure using the EsophyX device before hiatal hernia repair (HHR) in patients with chronic gastroesophageal reflux disease (GERD) symptoms. The study evaluated the symptom resolution, safety, patient satisfaction and efficacy of this approach. The prospective study data was presented at the American College of Gastroenterology 2017 Annual Scientific Meeting, in Orlando, FL.

“While some patients may experience temporary relief from PPI medications, this study offers substantial evidence that HHR-TIF 2.0 procedures can provide lasting relief from chronic GERD symptoms, and improve patients’ quality of life,” said co-author of the study, Dr Peter Janu of Wisconsin. “Our symptomatic outcomes confirm the excellent safety profile and the effectiveness of this combination procedure up to one year despite the initial larger hiatal hernia.”

The EsophyX technology is used to reconstruct the gastroesophageal valve (GEV) and restore its function as a barrier, preventing stomach acids refluxing back into the oesophagus. In June 2017, the FDA expanded the indication for the EsophyX device to include patients with hiatal hernias larger than 2cms when a laparoscopic hiatal hernia repair (HHR) reduces the hernia to 2cms or less.

The EsophyX device with SerosaFuse fasteners and accessories are indicated for use in transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract. They are indicated for the treatment of symptomatic chronic GERD in patients who require and respond to pharmacological therapy.

Transoral Incisionless Fundoplication procedure for reflux is performed without the need for external incisions through the skin, the TIF procedure offers patients who require an anatomical repair an effective treatment option to correct the underlying cause of GERD.

In the study, 99 patients with a confirmed diagnosis of GERD symptoms at two community-based hospitals underwent the TIF 2.0 procedure immediately following a laparoscopic HHR in the same anaesthetic session. All participants enrolled were symptomatic on proton pump inhibitor (PPI) medications with hiatal hernias between 2 and 5cms.

Overall, the study met the primary efficacy and safety endpoints with no treatment-related adverse events, concluding that TIF 2.0 procedures can be safely and efficiently performed immediately following HHR. The study also met the secondary endpoints, with most patients reporting 80 percent improvement for heartburn and regurgitation and more than 50 percent improvement for bloating and dysphagia.

“Findings from the prospective study support HHR-TIF 2.0 procedures as a potential new option for patients suffering from hiatal hernias greater than 2cms,” said co-author of the study, Dr Peter Mavrelis of Indiana. “We are excited to share these results and build upon the robust clinical data supporting the TIF 2.0 procedure as a durable treatment option for patient suffering from GERD.”

“EndoGastric Solutions would like to congratulate the lead investigators, Drs Janu and Mavrelis, for publishing a very important study,” said Skip Baldino, President and CEO, EndoGastric Solutions. “This compelling data and the FDA’s expanded label indication, will provide millions of patients access to a durable and effective solution to treat chronic symptoms of GERD.”

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