Expert Presents Significant Body of Data from Randomized Controlled Trials of EndoGastric Solutions®’ Transoral Incisionless Fundoplication (TIF®) Procedure for GERD at SAGES 2015

Data shows positive results from 192 patients followed up to 12-months at multiple centers

SAN MATEO, Calif.--()--EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), today announced that Karim Trad, MD, presented a review of data from EndoGastric Solutions’ multi-center, randomized, controlled TEMPO and RESPECT studies for the TIF procedure at SAGES 2015, the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons. SAGES runs from April 15 to 18, 2015 in Nashville.

“Taken together, these two well-designed, randomized controlled trials highlight the significant benefits of the TIF procedure in well-selected GERD patients with incomplete symptom control on high-dose PPI therapy,” said Dr. Trad, surgeon at George Washington University School of Medicine and Health Sciences and the principal investigator of the TEMPO study who also participated in the RESPECT study.

“The TIF procedure is capable of dramatically eliminating GERD symptoms, healing esophagitis and improving quality of life with minimal or no side effects. The recent multi-center study data has proven this incisionless, endoluminal approach as more effective than PPI drugs at eliminating troublesome regurgitation in a sub-group of chronic GERD patients, which is a significant achievement for this disease,” concluded Dr. Trad.

Dr. Trad reviewed the results of the RESPECT and TEMPO studies for his presentation, “Endolumenal Therapies are the Best Option,” during a Half-Day Postgraduate Course, Advances in Foregut Surgery that ran from 7:30 a.m. CT to noon CT on Wednesday, April 15.

About the RESPECT Study

RESPECT is the first-ever blinded, randomized, sham- and placebo-controlled, multicenter clinical study of the Transoral Incisionless Fundoplication (TIF®) procedure. As previously reported, 67% 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 reported elimination of troublesome regurgitation per Montreal consensus criteria after six months.1 Meanwhile, of the 42 patients who were randomized to undergo sham surgery and then continued an optimized dose of proton pump inhibitor (PPI) regimen (omeprazole), 45% reported elimination of the same symptom (p=0.023).

In addition, 77% of the TIF patients had healed their reflux esophagitis. The 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).

About the TEMPO Study

TEMPO is a prospective, randomized, multicenter clinical trial during which all 21 patients in the original control arm who had received maximum-dose proton pump inhibitor (PPI) therapy for the first six months of the trial crossed over to undergo the TIF procedure. This group achieved similar positive six-month results to the patients in the original treatment arm. Seventy-seven percent of patients in original treatment arm (n-39) reported a global elimination of daily troublesome regurgitation and atypical symptoms 12 months following the TIF procedure. Esophagitis, or inflammation of the esophagus, remained healed in 100% of the patients in the original treatment arm.2

Over 50 peer-reviewed studies of the TIF procedure have been published in medical journals with results from over 800 unique patients treated.

About GERD

Gastroesophageal Reflux Disease (GERD) is a chronic condition in which the gastroesophageal valve (GEV) allows gastric contents to wash back up into the esophagus, causing heartburn and possible injury to the esophageal lining. The stomach produces hydrochloric acid and other digestive enzymes after a meal to aid in the digestion of food. The cells that line the stomach are coated with a protective mucus that can withstand gastric contents, while the cells that line the esophagus lack the same protection.

GERD is the most common gastrointestinal-related diagnosis made by physicians during clinical visits in the U.S. It is estimated that pain and discomfort from acid reflux impacts over 23 million people two or more times per week in the U.S. The standard recommendations for symptomatic GERD patients include lifestyle changes (e.g. diet, scheduled eating times, and sleeping positions) and escalating doses of prescription medications for prolonged periods of time. Long-term, maximum dose usage of prescription medications has been linked to a variety of other health complications.

About the EsophyX® device

The EsophyX device was FDA cleared in 2007, and is commercially available in the United States. Inserted through the patient’s mouth with visual guidance from an endoscope, the EsophyX device is used to reconstruct the gastroesophageal valve (GEV) in order to restore its function as a barrier to prevent stomach acids from washing back up into the esophagus.

About Transoral Incisionless Fundoplication (TIF®) procedure for reflux

Performed entirely through the mouth without the need for external incisions through the skin, the TIF procedure offers patients who require an anatomical change to correct the underlying cause of GERD, another treatment option beyond traditional surgery. Studies show that for up to three years after the TIF procedure esophageal inflammation (esophagitis) is eliminated and most patients are able to stop using daily PPI medications to control symptoms.

The TIF procedure has an established safety and efficacy profile with more than 16,700 patients treated worldwide. For more information, visit www.GERDHelp.com.

About EndoGastric Solutions®

EndoGastric Solutions, Inc. (www.endogastricsolutions.com), headquartered in San Mateo, California, is a leader in the endoluminal treatment of digestive diseases. EGS’ mission is to combine the most advanced concepts in gastroenterology and surgery to develop products and procedures that address unmet needs in gastrointestinal diseases.

1 Hunter, John G., et al. Efficacy of Transoral Fundoplication vs Omeprazole for Treatment of Regurgitation in a Randomized Controlled Trial, Gastroenterology, Volume 148(2): 324-333.e5, http://www.gastrojournal.org/article/S0016-5085(14)01208-6/abstract

2 Trad KS, Simoni G, Barnes WE, et al. Efficacy of Transoral Fundoplication for Treatment of Chronic Gastroesophageal Reflux Disease Incompletely Controlled with High-Dose Proton-pump Inhibitors Therapy: a Randomized, Multicenter, Open label, Crossover study. BMC Gastroenterol. 2014;14(1):174, http://www.biomedcentral.com/1471-230X/14/174

The EsophyX2 HD device with SerosaFuse fastener and accessories is indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease.

Contacts

EndoGastric Solutions, Inc.
Debbie Donovan, 650-578-5120
ddonovan@endogastricsolutions.com
or
Lazar Partners, LTD
Hollister Hovey, 646-871-8482 (direct)
hhovey@lazarpartners.com

Release Summary

Expert Presents Significant Body of Data from Randomized Controlled Trials of EndoGastric Solutions®’ Transoral Incisionless Fundoplication (TIF®) Procedure for GERD at SAGES 2015

Contacts

EndoGastric Solutions, Inc.
Debbie Donovan, 650-578-5120
ddonovan@endogastricsolutions.com
or
Lazar Partners, LTD
Hollister Hovey, 646-871-8482 (direct)
hhovey@lazarpartners.com