Health Economic Data for TIF Procedure Also Highlighted
REDMOND, Washington – EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), today announced updated one-year clinical data from the RESPECT (Randomized EsophyX® vs. Sham/Placebo Controlled Trial) study, the first-ever randomized, blinded, sham- and placebo-controlled study of the company’s Transoral Incisionless Fundoplication (TIF®) procedure. The RESPECT study, along with a second separate study of health economic data comparing reflux treatment methods including the TIF procedure, will be presented at the American College of Gastroenterology (ACG) 2015 Annual Scientific Meeting, October 16- 21, 2015 in Honolulu, Hawaii.
Eighty-seven patients were randomly assigned to the group that underwent the TIF procedure and then received an ongoing treatment of placebo medication. After more than 12 months, 72% reported elimination of troublesome regurgitation per Montreal consensus criteria.1
The study also found that the mean DeMeester Score decreased from 33.6 to 23.9 at 6 months and to 24.7 at > 12 months post-TIF (p < 0.05).
Eight participating U.S. academic and community centers screened 696 patients of which 129 were enrolled into the RESPECT study: TIF/placebo n=87; SHAM/PPI n=42.
“The 12-month data from the RESPECT study further supports the TIF procedure as an effective treatment option to eliminate troublesome regurgitation and improves the quality of life for select chronic GERD patients,” said Peter Kahrilas, MD, Professor of Medicine-Gastroenterology, Northwestern University and co-principal investigator.
Both groups of patients enrolled in the RESPECT study, and their caregivers, were blinded to therapy during follow-up which occurred at two, 12 and 26 weeks. At the six-month follow-up, all patients were un-blinded and the sham control patients were given the opportunity to have a TIF procedure; 76% of sham/placebo group elected to crossover and receive a TIF procedure after un-blinding.
The RESPECT 12 month follow-up data will be displayed as a poster on Tuesday, October 20, 2015, 9:30 AM – 3:30 PM local time.
“Based on the improvements seen in these patients, we believe the TIF procedure is filling a treatment gap for patients who do not respond to PPI medications and want a less invasive procedure,” said Skip Baldino, President and CEO of EndoGastric Solutions.
About Economic Data Study
Also being presented are results of a two-year study demonstrating the improved cost and healthcare utilization benefits of the TIF procedure in comparison to PPI medication and Nissen fundoplication.
In this study, the Optum healthcare database was utilized to determine overall resource utilization, which includes costs for hospitalizations, outpatient visits and PPI therapy. Of the 13,293 total patients included in the analysis, 10,486 patients were on high-dose PPI therapy, 2,734 underwent Nissen fundoplication, and 73 patients had the TIF procedure. At two years post-TIF procedure, median costs were comparable to those post-Nissen (TIF – $7,397, Nissen – $8,412) and healthcare utilization and total healthcare costs decreased compared to those associated with PPIs (TIF – $7,397, PPIs – $9,697).
“The TIF procedure is showing potential not only as a desirable GERD treatment, but as a cost-effective solution for patients,” said Lauren Gerson, MD, MSc, gastroenterologist at California Pacific Medical Center in San Francisco, CA. Dr. Gerson is the lead author of the study; this poster will also be on display Tuesday, October 20, 2015, 9:30 AM – 3:30 PM local time.
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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