Significantly More TIF/Placebo Patients Experienced Elimination of Troublesome Regurgitation as Compared to Sham/PPI Patients
SAN MATEO, Calif.–EndoGastric Solutions (EGS) announces that Gastroenterology, the official journal of the American Gastroenterological Association (AGA) Institute and the most prominent journal in the field of gastrointestinal disease, has published landmark data from the first-ever blinded, randomized, sham- and placebo-controlled clinical study of the Transoral Incisionless Fundoplication (TIF®) procedure.
Of the 87 patients who were randomly assigned to the group that underwent the TIF procedure and then received an ongoing course of placebo medication, after six months 67% reported elimination of troublesome regurgitation per Montreal consensus criteria.1 Meanwhile, of the 42 patients who were randomized to undergo sham surgery and then continued to take optimized doses of proton pump inhibitor (PPI) regiment (omeprazole), 45% reported elimination of the same symptom (p=0.023).
“Consistent with the Montreal definition, the RESPECT (Randomized EsophyX® vs. Sham/Placebo Controlled Trial) study enrolled patients with troublesome regurgitation and objectively confirmed gastroesophageal reflux disease (GERD). This is the first ever randomized blinded trial to focus exclusively on regurgitation,” said John Hunter, MD, Mackenzie Professor & Chairman of Surgery, Oregon Health & Science University and co-principal investigator.
“The data demonstrates that the TIF procedure is more effective than optimized PPI drugs at eliminating troublesome regurgitation in selected chronic GERD patients with hiatal hernia less than 2 cm,” continued Dr. Hunter.
In addition, 77% of the TIF patients had healed their reflux esophagitis. TIF procedure was also associated with a decrease in all acid exposure parameters while patients in the control group had no detectable improvements in pH control (p<0.001).
“In other studies, the therapeutic gain of PPI therapy over placebo for the control of regurgitation is modest. Data from this well designed study suggest that the TIF procedure provides an attractive option to manage troublesome GERD symptoms, especially considering a notable absence of troublesome dysphagia and bloating after the TIF procedure,” said Peter Kahrilas, MD, Professor of Medicine-Gastroenterology, Northwestern University and co-principal investigator.
“We are pleased to have the RESPECT data published in Gastroenterology,” said Skip Baldino, President and CEO of EndoGastric Solutions. “In a recent New England Journal of Medicine editorial,2 the medical device industry was challenged to conduct more sham controlled trials in order to validate novel procedures and devices; we are thrilled that RESPECT has met this most rigorous scientific test.”
Both groups of patients enrolled in the RESPECT study, and their caregivers, were blinded to therapy during follow-up which occurred at two, 12 and 26 weeks. At the six month follow-up, all patients were un-blinded and the sham control patients were given the opportunity to have a TIF procedure.
Eight participating academic and community centers screened 696 patients of which 129 were enrolled into the RESPECT study. The investigators, consisting of 15 general surgeons and a gastroenterologist, will follow the patients for 12 months. Additional information about the RESPECT study can be found at www.clinicaltrials.gov. Abstract is available here.
Gastroesophageal reflux disease (GERD) is a common gastrointestinal disease that affects nearly 20 percent of the U.S. population. It 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 United States (U.S.), GERD is the most common gastrointestinal-related diagnosis physicians make during clinical visits. Some patients may have mild or moderate symptoms of GERD, while others have more severe manifestations causing chronic heartburn, asthma, chronic cough, and hoarse voice or chest pain. Left untreated, GERD can develop into a pre-cancerous condition called Barrett’s esophagus, which is a precursor for esophageal cancer. The first treatment recommendation for patients with GERD is to make lifestyle changes (e.g., diet, scheduled eating times and sleeping positions). Proton pump inhibitor (PPI) medications are commonly used to treat GERD, but there are a variety of health complications associated with long-term dependency on PPIs, and more than 10 million Americans are refractory to PPI therapy and may opt for surgery.
About Transoral Incisionless Fundoplication (TIF® 2.0 procedure) for Reflux
The TIF 2.0 procedure enables an incisionless approach to fundoplication in which a device is inserted through the mouth, down the esophagus and into the upper portion of the stomach. This approach offers patients looking for an alternative to traditional surgery an effective treatment option to correct the underlying cause of GERD. Based on clinical studies, most patients stopped using daily medications to control their symptoms and had their esophageal inflammation (esophagitis) eliminated up to five years after the TIF 2.0 procedure. Additionally, clinical results have demonstrated that concomitant laparoscopic hiatal hernia repair (LHHR) immediately followed by TIF 2.0 procedure is safe and effective in patients requiring repair of both anatomical defects.
Over 22,000 TIF procedures have been performed worldwide. More than 100 peer-reviewed papers have consistently documented the sustained improved clinical outcomes and exemplary safety profile the TIF procedure provides to patients suffering from GERD. For more information, please visit www.GERDHelp.com.
With the support of clinical societies, commercial and federal insurance providers, representing more than 100 million lives, have recognized the value of the TIF 2.0 procedure through recently expanded coverage policies. The TIF 2.0 procedure is a covered benefit for all Medicare beneficiaries across the country.
For the TIF 2.0 procedure, physicians and hospitals can reference CPT Code 43210 EGD esophagogastric fundoplasty. CPT is a registered trademark of the American Medical Association.
About EsophyX® Technology
The EsophyX technology is used to reconstruct the gastroesophageal valve (GEV) and restore its function as a barrier, preventing stomach acids from refluxing back into the esophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope, and enables creation of a 3 cm, 270° esophagogastric fundoplication. The U.S. Food and Drug Administration cleared the original EsophyX device in 2007. The evolving technology, including the latest iteration EsophyX Z+, launched in 2017, enables surgeons and gastroenterologists to use a wide selection of endoscopes to treat the underlying anatomical cause of GERD.
The EsophyX device, with SerosaFuse® fasteners and accessories, is indicated for use in transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract. It is 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 ≤ 2 cm in size in patients with symptomatic chronic GERD. Patients with hiatal hernias larger than 2 cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2 cm or less.
About EndoGastric Solutions®
Based in Redmond, Washington, 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 products and procedures to treat gastrointestinal diseases, including the TIF 2.0 procedure—a minimally invasive solution that addresses a significant unmet clinical need. Join the conversation on Twitter: @GERDHelp Facebook: GERDHelp and LinkedIn: EndoGastric Solutions.
# # #