Cost comparison analysis indicates significantly lower healthcare utilization by TIF procedure patients
REMOND, Wash. – EndoGastric® Solutions today announced that Surgical Innovation: Advances in Minimally Invasive Surgical Science, Technology, and Training has published five year follow-up data focused on control of GERD symptoms and healthcare economics after a Transoral Incisionless Fundoplication (TIF®) 2.0 procedure in a study called TEMPO (TIF® EsophyX vs Medical PPI Open Label).
At five years post-procedure, these results are the longest available follow-up data from randomized controlled trials of the TIF 2.0 procedure. All primary endpoints of the TEMPO study were met, with 86 percent of patients reporting the elimination of regurgitation and 80 percent of patients reporting elimination of all atypical symptoms. Further, the data released indicates that treatment with the TIF 2.0 procedure improved health-related quality of life scores (p<0.001) and patient satisfaction (two versus 70 percent) for patients with gastroesophageal reflux disease.
“This report offers conclusive evidence that the early benefits and safety reported with the TIF 2.0 procedure in previous shorter-term prospective multi-center randomized reports and prospective multi-center observational studies are sustained at 5 years follow-up—a milestone that has never been achieved by previous endoluminal GERD therapies,” said Karim Trad, MD, Clinical Professor of Surgery at George Washington University School of Medicine and Health Sciences and principal investigator. “The elimination of troublesome symptoms was maintained without significant deterioration over time, with a low re-operation rate of 5% after 5 years. Going forward, the endoscopic TIF 2.0 procedure should be considered as a first-line therapy in carefully selected patients resistant or intolerant to PPIs.”
In the TEMPO study, sixty-three patients who suffered from chronic GERD symptoms were randomly assigned to either undergo TIF 2.0 procedure (n=40) using the EsophyX device or to receive proton pump inhibitor (PPI) therapy (n=23). Six months after the start of the study, all patients receiving PPI treatment (n=21) elected to crossover and receive the TIF 2.0 procedure. At five-year follow-up, data from 44 patients were available for analysis.
This report also included an economic analysis using the Optum healthcare database to determine overall healthcare utilization, which incorporated costs for hospitalizations, outpatient visits and PPI therapy. At two years post-TIF procedure, healthcare utilization and total healthcare costs were significantly less when compared to those associated with laparoscopic Nissen fundoplication ($66,000 for TIF procedures verses $124,000 for laparoscopic Nissen fundoplication patients).
“EndoGastric Solutions has consistently invested in the highest-grade research to validate the long-term effectiveness and healthcare economics of the TIF 2.0 procedure,” said Skip Baldino, President and CEO of EndoGastric Solutions. “We are very encouraged that these investments continue to confirm that the TIF 2.0 procedure is a safe, efficacious, and viable endoscopic alternative to PPIs and more invasive anti-reflux surgery options.”
Detailed results, durability and economic data from the TEMPO trial were published online February 6, 2018, by Surgical Innovation: Advances in Minimally Invasive Surgical Science, Technology, and Training affiliated with the Institute for Research into Cancer of the Digestive System and can be viewed 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.
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