REDWOOD CITY, Calif.―EndoGastric Solutions (EGS), a company that focuses on endoluminal reconstructive treatment for gastroesophageal reflux disease (GERD), today announced the presentation of two-year data from the Transoral Incisionless Fundoplication (TIF®) US Registry at the 2013 SAGES Annual Meeting during the therapeutic endoscopy scientific session in Baltimore.

The TIF procedure was safe and effective in eliminating or improving a range of typical and atypical GERD symptoms, including heartburn and reflux, in up to 81 percent of patients in the study, EGS reported today. Also, in 81 percent of patients undergoing endoscopy 24 months after their TIF procedure, esophagitis was fully healed or notably improved.

“This two-year data demonstrates the long-term value of a transoral anatomic correction in the treatment of GERD patients with mild to moderate disease,” said Mike Kleine, president and CEO of EGS. “We are very encouraged by the sustained response seen by patients with either typical or atypical symptoms.”

Twenty-four months after the EsophyX2 device was used in TIF procedures, more than two-thirds of patients completely eliminated the need for daily proton pump inhibitor (PPIs) therapy, according to EGS. Symptom control achieved at six months remained stable over time, indicating durability of the TIF procedure.

“The TIF procedure is an attractive option because it dramatically shifts the risk-benefit ratio associated with correcting the underlying anatomical defect and allows a majority of patients to stop taking daily medication for reflux,” said Karim Trad, MD, FACS, SAGES presenter and an investigator in this prospective multicenter registry of patients with chronic GERD.

The risks associated with medical management of GERD patients for years or decades are becoming more evident. Traditional surgical interventions for GERD have historically been reserved for patients with the most severe disease. However, most patients have been unwilling to accept the well-documented side effects of difficulty swallowing and gas bloat associated with traditional surgery. In stark contrast, the TIF procedure offers an alternative option to select GERD patients because almost none of these side effects occurred in the TIF registry population.

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. TIF is a surgical solution that corrects the root cause of GERD—a disease that affects more than 60 million people in the United States.

The TIF procedure is based on traditional surgical principles, is minimally invasive and offers similar effectiveness to a surgical repair with the safety profile of a transoral approach. To date, more than 10,000 patients have been treated worldwide.