REDMOND, Wash.--(BUSINESS WIRE)--EndoGastric Solutions today announced the publication of new clinical data demonstrating high rates of pH normalization and improved clinical outcomes in patients with gastroesophageal reflux disease (GERD) undergoing laparoscopic hiatal hernia repair followed by the Transoral Incisionless Fundoplication (TIF® 2.0 procedure). The TIF 2.0 procedure is a minimally invasive endoscopic intervention performed with the EsophyX® device that enables anatomic correction of the gastroesophageal valve without the resulting complications associated with traditional fundoplication. The retrospective data are reported in a paper titled “pH Scores in Hiatal Repair with Transoral Incisionless Fundoplication,” and appear in the January - March 2019 issue of the Journal of the Society of Laparoendoscopic Surgeons.1
Hiatal defects are common in GERD patients. In 2016, the U.S. Food and Drug Administration granted EndoGastric Solutions clearance to expand the EsophyX device’s indications for use to include patients with a hiatal defect greater than 2 cm when it is surgically corrected just prior to TIF 2.0 procedure.2
“This is the first study to demonstrate that a concomitant hiatal hernia repair and TIF 2.0 procedure yields statistically significant improvements in pH exposure, an objective measurement in the treatment of GERD,” said Glenn Ihde, MD, a board-certified general surgeon at the Matagorda Medical Group in Bay City, Texas, and lead author of the publication. “Significantly, pH scores were normalized in 95 percent of patients with intact hiatal repair at follow-up assessment. This patient group also experienced a decrease in bloating syndrome related to traditional laparoscopic fundoplication. These promising results warrant further evaluation in additional prospective studies of this set of concomitant procedures.”
“This is the first study to demonstrate that a concomitant hiatal hernia
repair and TIF 2.0 procedure yields statistically significant
improvements in pH exposure, an objective measurement in the treatment
of GERD”
Glenn Ihde, MD
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The new study is a retrospective analysis of 97 GERD patients evaluated between October 2015 and December 2017 with mean follow-up evaluation at 296 days. Patients in the study experienced heartburn and/or regurgitation and had a history of proton pump inhibitor (PPI) use that averaged 8 years. All patients had positive indications of GERD, 55 of the 97 patients proceeded to hiatal hernia repair with concomitant TIF 2.0 procedure. Of these 55 patients, 29 (53%) had matched pre- and post-operative assessments. Key findings among these 29 patients include:
- Twenty-two of the 29 patients had intact hiatal hernia and TIF procedure repairs.
- Of the 22 intact repairs, 21 patients showed normalization of pH scores (95%).
- A significant improvement in average pH scores from baseline of 35.3 to 10.9 at follow-up (p<0.01).
- A significant improvement in average GERD health-related quality-of-life (HRQL) scores from baseline 33.75 to 9.07 at follow-up (p<0.01).
- A significant improvement in average Reflux Symptom Index (RSI) scores from baseline of 20.32 to 8.07 at follow-up (p<0.01).
- There were no serious adverse events.
“These findings support the safety and efficacy of concomitant hernia repair and TIF 2.0 procedure with the EsophyX device,” said Skip Baldino, President and CEO of EndoGastric Solutions. “This is an important advance for patients with hiatal defects of two centimeters or more, as the data show improved objective and subjective assessments of GERD symptoms. We look forward to additional prospective studies to provide physicians with additional data surrounding improved outcomes for their patients utilizing this approach.”
About GERD
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.
About Reimbursement
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.
Indications
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.
1 Ihde GM, Pena C, Scitern C, Brewer S. pH Scores in Hiatal Repair with Transoral Incisionless Fundoplication. JSLS. 2019;23(1):e2018.00087
2 Ihde GM, Besancon K, Deljkich E. Short-term safety and symptomatic outcomes of transoral incisionless fundoplication with or without hiatal hernia repair in patients with chronic gastroesophageal reflux disease. Am J Surg. 2011; 202(6):740-7.