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 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 U.S., GERD is the most common gastrointestinal-related diagnosis physicians make during clinical visits. Pain and discomfort from acid reflux impact more than 80 million Americans at least once a month according to estimates. The first treatment recommendations for GERD patients is to make lifestyle changes (e.g., diet, scheduled eating times and sleeping positions). Patients are instructed to take prescription medications; unfortunately, it is a common practice to increase medication doses and, over time, become dependent on these medications to control symptoms. A variety of other health complications are linked to the long-term, maximum-dose usage of prescription medications.
About Transoral Incisionless Fundoplication (TIF®) procedure for reflux
Performed without the need for external incisions through the skin, the TIF procedure offers patients who require an anatomical repair an effective treatment option to correct the underlying cause of GERD. Most patients stopped using daily medications to control symptoms and had their esophageal inflammation (esophagitis) eliminated up to three years after the TIF procedure based on studies.
There have been more than 20,000 TIF patients treated worldwide since the EsophyX® device launched. In the past ten years, over 60 centers published more than 80 peer-reviewed papers. These studies document consistent outcomes on over 1,300 unique study patients. For more information, visit www.GERDHelp.com.
Commercial and federal payer partnerships representing over 100 million lives have recognized the value of the TIF procedure through recent contract and coverage reimbursement expansions. EndoGastric Solutions has confirmed coverage for all Medicare enrollees through Medicare Administrative Contractors (MACs)—CGS, First Coast, NGS, Noridian, Novitas, Palmetto, WPS.
Annually, the Federal Register posts unadjusted average payments specific to the CPT® code for physicians and hospital Ambulatory Payment Codes (APC), allowing patients to receive access to treatment more easily for GERD. For the TIF procedure, physicians can reference CPT Code 43210 EGD esophagogastric fundoplasty and hospitals can reference APC 5362 Level 2 Laparoscopy Procedures. CPT is 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 refluxing back into the esophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope. The U.S. Food and Drug Administration cleared the original EsophyX device in 2007. EndoGastric Solutions® launched the third generation EsophyX device, the EsophyX Z model, in 2015. The evolving EsophyX technology now enables surgeons and gastroenterologists to use a wider selection of endoscopes to treat the underlying anatomical cause of GERD. These options include low profile and larger high-definition models.
The EsophyX device with SerosaFuse® fasteners and accessories are indicated for use in transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract. They are 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 ≤ 2cm in size in patients with symptomatic chronic GERD. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less.
About EndoGastric Solutions®
Based in Redmond, WA, 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 the Transoral Incisionless Fundoplication (TIF®) 2.0 procedure—a minimally invasive solution that addresses a significant unmet clinical need. Join the conversation on Twitter: @GERDHelp Facebook: GERDHelp and Google+: GERDHelp, LinkedIn: EndoGastric Solutions.
EndoGastric Solutions, Inc.
Phone: +1 408-621-0216