Longest follow-up data from randomized controlled trial classifies the TIF procedure as a durable alternative to medications and traditional anti-reflux surgery
REDMOND, Wash. – EndoGastric® Solutions (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), today announced the presentation of four-year follow-up data from TEMPO (TIF® EsophyX vs Medical PPI Open Label), a prospective, randomized, multicenter clinical study confirming long-term control of chronic GERD symptoms after a Transoral Incisionless Fundoplication (TIF®) 2.0 procedure.
During the study trial, sixty-three patients who suffered from chronic GERD symptoms were randomized to either undergo TIF 2.0 procedure (n=40) using the EsophyX device or take proton pump inhibitor (PPI) therapy (n=23); all remaining PPI patients (n=21) elected to cross over and receive TIF procedures six months after the start of the study.
All primary endpoints of the study were met with 89 percent of patients reporting the elimination of regurgitation and 87 percent of patients reporting elimination of all atypical symptoms at four years post-procedure.
Dr. Karim S. Trad, Clinical Professor of Surgery at George Washington University School of Medicine and principal investigator will present the study data on September 7 at 2:00 PM PST as part of the Minimally Invasive Surgery Week 2017, Society of Laparoendoscopic Surgeons (SLS) 2017 Annual meeting at the Hilton Union Square Hotel in San Francisco, California.
“This new four-year analysis represents an important clinical milestone for patients who no longer benefit from PPI therapy and are seeking lasting relief from chronic GERD symptoms,” said Dr. Trad. “The results of this comprehensive study confirm the endoscopic TIF 2.0 procedure as a durable alternative to PPIs and more invasive anti-reflux surgery operations.”
“The recent data from this multi-center study reaffirms the existing clinical evidence that supports the TIF 2.0 procedure as an effective long-term treatment option for patients who suffer from GERD symptoms despite the use of PPIs,” said Skip Baldino, President and CEO of EndoGastric Solutions. “Many thanks to Dr. Trad and the other investigators for their continued contributions to improve long-term patient outcomes.”
Gastroesophageal reflux disease (GERD) is a chronic condition in which the gastroesophageal valve (GEV) allows gastric contents to reflux (wash backwards) into the esophagus, causing heartburn and possible injury to the esophageal lining. In the U.S., GERD is the most common gastrointestinal-related diagnosis physicians make during clinical visits. Pain and discomfort from acid reflux impact more than 80 million Americans at least once a month according to estimates. The first treatment recommendations for GERD patients is to make lifestyle changes (e.g., diet, scheduled eating times and sleeping positions). Patients are instructed to take prescription medications; unfortunately, it is a common practice to increase medication doses and, over time, become dependent on these medications to control symptoms. A variety of other health complications are linked to the long-term, maximum-dose usage of prescription medications.
About Transoral Incisionless Fundoplication (TIF®) procedure for reflux
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. Most patients stopped using daily medications to control symptoms and had their esophageal inflammation (esophagitis) eliminated up to three years after the TIF procedure based on studies.
There are more than 20,000 TIF patients treated worldwide since the EsophyX® device launched. In the past ten years, over 60 centers published more than 80 peer-reviewed papers. These studies document consistent outcomes on over 1,300 unique study patients. For more information, visit www.GERDHelp.com.
About EsophyX® technology
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 esophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope. The U.S. Food and Drug Administration cleared the original EsophyX device in 2007. EndoGastric Solutions® launched the third generation EsophyX device, the EsophyX Z model, in 2015. The evolving EsophyX technology now enables surgeons and gastroenterologists to use a wider selection of endoscopes to treat the underlying anatomical cause of GERD. These options include low profile and larger high-definition models.
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. The device is also indicated to narrow the gastroesophageal junction, and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic GERD. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less.
About EndoGastric Solutions®
Based in Redmond, WA, EndoGastric Solutions, Inc. (www.endogastricsolutions.com), is a medical device company developing and commercializing innovative, evidence-based, incisionless surgical technology for the treatment of GERD. EGS has combined the most advanced concepts in gastroenterology and surgery to develop the Transoral Incisionless Fundoplication (TIF®) 2.0 procedure—a minimally invasive solution that addresses a significant unmet clinical need. Join the conversation on Twitter: @GERDHelp Facebook: GERDHelpcom and Google+: GERDHelp.