TEMPO Study Level 1 Data Directly Comparing Transoral Incisionless Fundoplication (TIF) Procedure to PPI Use Presented at DDW® 2013
Redwood City, CA (May 21, 2013)–EndoGastric Solutions® (EGS), the leader in endoluminal reconstructive treatment for gastroesophageal reflux disease (GERD), today announced new data from a prospective, randomized, controlled trial show that patients with GERD who underwent Transoral Incisionless Fundoplication (TIF®) procedures with the EsophyX® device experienced significantly better outcomes in reduction of troublesome GERD symptoms after six months than patients who continued to take maximum daily doses of proton pump inhibitor (PPI) medications for that time period.
In this study, Transoral Incisionless Fundoplication (TIF) was superior to maximal PPI dose in elimination of daily troublesome typical and atypical chronic GERD symptoms such as heartburn, regurgitation, globus sensation, hoarseness and cough at 6-month follow-up.
Daily bothersome heartburn was eliminated in 90% of patients in the TIF group versus only 13% in the PPI group. Furthermore, 90% of patients in the TIF group completely ceased PPI use. Both groups achieved similar normalization of distal esophageal acid exposure (54% of patients in the TIF group and 52% of patients in the PPI group). There was no difference between treatment groups in the clinical characterizations of the disease at baseline.
Karim S. Trad, MD, surgeon at George Washington University School of Medicine and Health Sciences, principal investigator of the TIF® versus Medical PPI Management of Refractory GERD symptoms (TEMPO) trial, presented the first six month data from the study during the American Gastroenterological Association’s Late-breaking abstract session at the 2013 DDW® Annual Meeting in Orlando, Florida.
“This randomized controlled study establishes for the first time that, for some patients, the TIF procedure is better than maximal dose PPI therapy in controlling a whole range of GERD symptoms,” said Dr. Trad. “Going forward, TIF should be offered as an alternative to the right patients who are not completely responsive to PPIs, or who are seeking to avoid the long-term side effects of medications”.
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. Patients implement these recommendations in an effort to manage their symptoms and, for many; quality of life becomes negatively impacted over time.
“The TIF procedure’s primary objective is to address failed anatomy in order to augment the body’s natural barrier and protect the esophagus from normal stomach chemistry,” said Mike Kleine, President and CEO of EGS. “Using drugs to artificially neutralize stomach acid for prolonged periods has to be problematic – stomach acid has an important role in normal GI function. A successful outcome for us is to normalize a patient’s life as much as possible.”
The TEMPO data include results from 63 patients treated at seven U.S. centers, including three gastroenterology practices and four general surgery practices. TEMPO was designed to assess the safety and efficacy of the TIF procedure as compared with high-dose PPI therapy to treat symptoms associated with chronic GERD. Patients will continue to be followed until they have completed 12-, 24-, and 36-month follow-up.
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.
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