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.
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 25,000 TIF procedures have been performed worldwide. More than 140 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.
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