TIF 2.0 procedure provides improved quality of life and elimination of daily PPI use for up to 10 years in patients with symptomatic GERD;
TIF 2.0 procedure combined with laparoscopic hiatal hernia repair is a safe and effective option for patients with severe GERD and hiatal hernia
REDMOND, Wash – EndoGastric® Solutions today announced the presentation of two clinical abstracts highlighting the efficacy of Transoral Incisionless Fundoplication (TIF®) 2.0 procedure for gastroesophageal reflux disease (GERD). The TIF 2.0 procedure is a minimally invasive procedure that enables physicians to perform an endoscopic gastric fundoplication. One abstract reports follow-up data to 10-year post-TIF 2.0 procedure and the other reports results of TIF 2.0 procedure immediately following laparoscopic hiatal hernia repair in patients with GERD. The abstracts are being displayed as posters on Saturday, June 2 at Digestive Disease Week (DDW) 2018 taking place in Washington, DC June 2-5.
Study Results
Transoral Incisionless Fundoplication with EsophyX (TIF 2.0) For Gastro-Esophageal Reflux Disease: Three- To Ten-Year Outcomes in A Prospective Observational Single-Center Study
Presented by: Professor Pier Alberto Testoni – San Raffaele Hospital, Milano, Italy
Session Number: 5230; Abstract Number: Sa1950
In this single-center study, TIF 2.0 procedure was performed using EsophyX® device in a series of 50 consecutive patients with symptomatic GERD responsive to PPIs. For the 3- to 10- year post-TIF period patients underwent annual assessment using the GERD-HRQL questionnaire and recording of PPI usage and results were compared with pre-TIF baseline values. Key study findings include:
- Over the 10-year follow-up the mean GERD-HRQL score was significantly reduced compared with the pre-TIF score (46±19) but appeared substantially unchanged between 2 and 10 years post-TIF procedure.
- The percentages of patients who stopped or halved their PPI therapy 3, 5, 7 and 10 years after TIF procedure were 84.4%, 73.5%, 83.3%, and 91.7%, respectively; this rate remained substantially stable and similar to that at 2 years (87.8%).
- TIF 2.0 procedure using the EsophyX device achieved a significant GERD-HRQL score improvement compared to baseline and lasting elimination of daily dependence on PPI in about 73-91% of patients for up to 10 years.
Efficacy of Combined Transoral Incisionless Fundoplication and Laparoscopic Hiatal Hernia Repair
Presented by: Dr. Viktor E. Eysselein – Harbor UCLA Medical Foundation, California, USA
Session Number: 5230; Abstract Number: Sa1932
This study evaluated TIF 2.0 procedures performed immediately after laparoscopic hiatal hernia repair in GERD patients with hiatal hernia greater than 2 cm and concluded the procedure is safe and an effective therapeutic option for patients with severe GERD and large hiatal hernia. Between June 2015 and September 2017, 27 patients with chronic GERD symptoms refractory to double-dose PPI and with a Hill Grade greater than 2, underwent the concomitant procedure. Patients were evaluated for indication, PPI use, pre- and post-procedure symptoms, patient satisfaction and complications 1-29 months post procedure (median follow-up was 11 months). Key study findings include:
- Daily PPI use was eliminated in 85% (23/27) of patients.
- At post-procedure follow-up, 96% (26/27) of patients reported satisfaction with concomitant procedure set.
- Specific GERD symptom prevalence improvements after treatment were noted: heartburn 70% to 26%; regurgitation 63% to 11%; cough 26% to 15% and hoarse voice 11% to 3%.
- There were no postoperative complications, and no dysphagia or gas-bloating symptoms were reported.
“These results underscore the clinical benefits the TIF 2.0 procedure can provide to a broad array of GERD patients,” said Dr. Peter Janu, Director of the Ascension NE WI Reflux Center of Excellence. “The improvements in health-related quality of life scores and elimination of daily proton pump inhibitor therapy (PPIs) use for up to 10-years suggests that the TIF 2.0 procedure is a viable and important treatment option for patients who do not want to undergo traditional more invasive surgical procedures or are intolerant to PPIs. Additionally, while the TIF 2.0 procedure has been shown to be effective in GERD patients with hiatal hernia less than two centimeters, this new data continues to reinforce that in combination with laparoscopic hiatal hernia repair, it’s also a safe and effective option for patients with a larger hiatal hernia.
“Dr. Testoni’s 10-year follow-up data adds to the durability evidence supporting the clinical utility of the TIF 2.0 procedure,” said Skip Baldino, President and CEO of EndoGastric Solutions. “Consistent with the FDA’s expanded label of the EsophyX device in June 2017, Dr Eysselein’s data further confirm that concomitant laparoscopic repair is safe and effective treatment options for the millions of patients with a larger hiatal hernia.
DDW Product Theater
EndoGastric Solutions is also sponsoring a symposium at DDW 2018 titled “Shaping the Future of GERD Management: Updates on the TIF 2.0 Procedure with EsophyX Device” from 1:15 p.m. EDT to 2:00 p.m. EDT on Sunday, June 3, in the DDW Product Theater. During the symposium, faculty will present the clinical utility of the TIF 2.0 procedure, including its concomitant use following hiatal hernia repair. Faculty members are:
- Kenneth J. Chang, M.D., Executive Director of the H.H. Chao Comprehensive Digestive Disease Center and Chief of the Division of Gastroenterology & Hepatology, Department of Medicine, UC Irvine School of Medicine
- Barham K. Abu Dayyeh, M.D., M.P.H., Gastroenterologist at the Mayo Clinic
- Peter G. Janu, M.D., Director of the Ascension Reflux Center of Excellence
About GERD
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 United States (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 medications—proton pump inhibitors; 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 dependency on PPIs.
About Transoral Incisionless Fundoplication (TIF®) procedure for reflux
A minimally invasive endoscopic treatment, performed without the need for external incisions through the skin, the TIF 2.0 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 five 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.
About Reimbursement
Commercial and federal insurance providers, representing over 100 million lives, have recognized the value of the TIF procedure through recently expanded contract and coverage reimbursement. 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.
Indications
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.
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Contact:
Debbie Donovan
EndoGastric Solutions, Inc.
Phone: +1 408-621-0216
ddonovan@endogastricsolutions.com
Erich Sandoval
Lazar Partners
Phone: +1 917-497-2867
esandoval@lazarpartners.com
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.