3-Year Study Shows Device Aids with Long-Term Control of Chronic GERD Symptoms

EndoGastric Solutions (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), has announced the presentation of three-year follow-up data from TEMPO, a prospective, randomized, multicenter clinical study. The data confirms long-term control of chronic GERD after a Transoral Incisionless Fundoplication (TIF) procedure with the EsophyX device. The study will be presented at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 2016 Annual meeting, taking place from March 16-19, 2016 in Boston, Massachusetts.
 
Sixty-three patients who suffered from troublesome chronic GERD symptoms were randomized to either undergo the TIF procedure (n=40) using the EsophyX device or take proton pump inhibitor (PPI) therapy (n=23); all patients in PPI control group crossed over and received TIF procedures six months after the start of the study.
 
At up to 36 months follow-up, 91 percent of patients reported elimination of troublesome regurgitation, 70 percent were able to completely stop PPI therapy, and reflux esophagitis healed in 87 percent of patients.
 
“Our data demonstrates that the benefits of transoral incisionless fundoplication are sustained up to three years following the procedure. Symptom control, reduction in acid exposure, healing of esophagitis, and cessation rates of PPIs are maintained over time, proving that the TIF procedure is a durable alternative to PPIs and more invasive anti-reflux operations” said Karim Trad, MD, Clinical Professor of Surgery at George Washington University School of Medicine and Health Sciences and principal investigator, who will present the data.
 
The data will be presented the SS08 Flexible Endoscopy session starting at 3:30 PM to 5:30 PM on Thursday, March 17, 2016 in Ballroom A moderated by Frederick L. Greene, MD and G. V. Rao, MS, MAMS.
 
EGS will also provide demonstrations of the EsophyX device for the TIF procedure at booth #416 in the SAGES exhibit hall from March 16-18.
 
“The ongoing, excellent results from this multi-center study represent another clinical milestone and add to the existing strong body of clinical evidence that support the TIF procedure as an excellent treatment option for patients who no longer benefit from PPIs and are seeking long-term relief from ongoing GERD symptoms,” said Skip Baldino, President and CEO of EndoGastric Solutions. “Our thanks to Dr. Trad and the other investigators for their ongoing commitment to providing the GERD patients they serve with a full armamentarium of treatment options.”
 
In 2015 SAGES, in cooperation with the three primary GI societies—AGA, ACG, ASGE, jointly sponsored an application to the American Medical Association for a new Category I Current Procedural Terminology (CPT) code. CPT 43210: EGD esophagogastric fundoplasty became effective January 1, 2016.