Study Found 59% of Patients Undergoing TIF Procedure Had Remission of Gastroesophageal Reflux Disease Symptoms after Six Months
REDMOND, Washington; October 15, 2015 – EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), today announced findings published online by Alimentary Pharmacology and Therapeutics from a new double-blind, sham-controlled, multi-center European study, which further confirmed the efficacy of the company’s Transoral Incisionless Fundoplication (TIF ®) procedure as a viable alternative to proton pump inhibitors (PPIs) to control chronic symptoms of GERD.
Prior to the TIF procedure, patients were required to refrain from PPI consumption for at least 10 days. Of the randomized patients treated with the TIF procedure, 59% were determined to be in remission after six months compared to 9% of patients in the sham treatment arm (p < 0.0001).
The study also reported TIF procedure patients had improved acid reflux time (measurements of esophageal acid exposure) from 8.89 to 3.73 (p = 0.0002) compared to the sham-controlled group which had no changes in acid reflux time.
“It can now be concluded that Transoral Incisionless Fundoplication (TIF2) offers chronic GERD patients, being on long-term treatment with PPI, an effective therapeutic alternative,” stated Lars Lundell, MD, lead investigator of the study and Professor of Medicine at Karolinska University, Huddinge Hospital, Stockholm. “In fact, we can also conclude that the level of scientific proof of its efficacy and therapeutic gain surpasses anything that is available outside the area of traditional laparoscopic anti-reflux therapy.”
This is the second randomized study using a sham-controlled group that was conducted on a demographically balanced and diverse body of 44 patients between 18 and 80 years old. Originally, from 406 initial contacts, 121 patients were screened who suffered from persistent GERD symptoms and relied on daily administration of PPIs for relief for at least six months prior to enrollment.
The paper “Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD” can be found here and a poster will be on display at United European Gastroenterology’s Week (UEGW) Conference in the Oesophageal, Gastric and Duodenal Disorders Section 1, October 26, 2015 09:00 to 17:00 local time at Fira de Barcelona – Gran Via Venue in Barcelona, Spain.
“This data is a new addition to the body of high quality TIF procedure evidence—it’s the fourth randomized controlled trial and second sham-controlled study,” said Skip Baldino, President and CEO of EGS. “This data aligns with RESPECT—our first sham-controlled study. In a recent New England Journal of Medicine editorial,1 the medical device industry was challenged to conduct more sham controlled trials in order to validate novel procedures and devices; Dr. Lundell’s study has also met this most rigorous scientific test.”