Updated ASGE Clinical Practice Guideline Includes TIF 2.0 and cTIF for Management of GERD
SOUTH JORDAN, Utah, March 27, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ:MMSI), a global leader of healthcare technology, announced today that the American Society for Gastrointestinal Endoscopy (ASGE) updated its guideline on the diagnosis and management of gastroesophageal reflux disease (GERD) to include Transoral Incisionless Fundoplication (TIF 2.0) and TIF 2.0 Consecutive Transoral Incisionless Fundoplication (cTIF)* procedures as evidence-based approaches to care.
GERD occurs when stomach acid flows into the esophagus, causing irritation of the tissue lining. Uncomfortable symptoms can include heartburn, upper stomach or chest pain, trouble swallowing, and chronic cough. A common chronic condition, GERD affects about 20% of people in the United States.1 Left untreated, GERD can lead to other serious complications over time.
A minimally invasive therapy, the TIF 2.0 procedure reconstructs the gastroesophageal valve and restores its function as a reflux barrier. TIF 2.0 can also be combined consecutively with a surgical hiatal hernia repair, in a procedure referred to as cTIF.
To diagnose and manage GERD, the ASGE developed an evidence-based guideline using the Grading of Recommendations Assessment, Development, and Evaluation framework. Updated from the 2014 ASGE guideline, the revised guideline addresses the role endoscopic anti-reflux therapy plays in the management and treatment of GERD, including TIF 2.0 and cTIF procedures.
"In patients with confirmed GERD with small hiatal hernias (≤ 2 cm) and Hill grade I or II who meet specific criteria, the ASGE suggests evaluation for TIF as an alternative to chronic medical management," the ASGE Standards of Practice Committee and co-authors wrote. "In patients with persistent GERD with large hiatal hernias (> 2 cm) and Hill grade III or IV, the ASGE suggests either cTIF or surgical therapy based on multidisciplinary review."3
"The recent update to the ASGE practice guidelines is a significant milestone for patients suffering with GERD. We have learned that TIF 2.0 and cTIF are both safe and efficacious and we now have level 1 evidence to prove it, which has led to societal endorsement," said Kenneth Chang, Executive Medical Director and Gastroenterologist at Hoag Digestive Health Institute in Newport Beach, CA, and founding faculty member of Merit's TIF physician education course. "The clinical evidence continues to build with a recent prospective multicenter cohort study4 of 85 patients (81 included in the outcomes analysis) examined patient-reported and clinical outcomes of GERD patients assessed at last follow-up within 12 months after TIF 2.0. Results showed a clinical success rate of 94%; GERD Health-Related Quality of Life scores improved in 89% of patients; elevated Reflux Symptom Index score normalized in 85% of patients with elevated baseline; and patient satisfaction improved from 8% to 79% (P < .0001). There were no TIF 2.0-related serious adverse events. The expectation is that with this evolution, more patients that qualify for TIF 2.0 or cTIF will have access to the procedure."
To help treat this patient population, Merit Medical offers the EsophyX® Z+ Device for use during TIF 2.0 and cTIF procedures. Designed to restore anatomy and reconstruct the gastroesophageal valve, the EsophyX Z+ Device helps provide relief of GERD symptoms and reduce acid reflux that can lead to long-term complications and risk. The EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the junction and reduce hiatal hernia ≤2cm in size in patients with symptomatic chronic gastroesophageal reflux disease. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less.
Learn more about the EsophyX Z+ Device.
"We're thrilled to see the TIF and cTIF procedures receive the attention they deserve as evidence-based approaches to treating GERD," said Fred P. Lampropoulos, Merit's Chairman and Chief Executive Officer. "Through our EsophyX Z+ technology, we look forward to helping physicians offer this standard of care to more patients."
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Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves customers worldwide with a domestic and international sales force and clinical support team totaling more than 800 individuals. Merit employs approximately 7,400 people worldwide.
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*Merit Medical defines the term "cTIF" as a consecutive Transoral Incisionless Fundoplication, which consists of a Hiatal Hernia Repair (HHR) followed by a Transoral Incisionless Fundoplication (TIF) procedure under a single anesthesia setting.
1. National Institute of Diabetes and Digestive and Kidney Disorders (NIH). 2020. "Definition & Facts for GER & GERD." Last modified July 2023. Definition & Facts for GER & GERD - NIDDK
2. Janu et al. 2019. "Laparoscopic Hiatal Hernia Repair Followed by Transoral Incisionless Fundoplication with EsophyX Device (HH + TIF): Efficacy and Safety in Two Community Hospitals." Surgical Innovation 26, no. 6 (Dec): 675–86. doi: 10.1177/1553350619869449.
3. The ASGE Standards of Practice Committee et al. 2024. "American Society for Gastrointestinal Endoscopy Guideline on the Diagnosis and Management of GERD: Summary and Recommendations." Gastrointest Endosc (Dec 17): S0016-5107(24)03559-4. doi: 10.1016/j.gie.2024.10.008.
4. Canto et al. 2025. "Outcomes of Transoral Incisionless Fundoplication (TIF 2.0): A Prospective Multicenter Cohort Study in Academic and Community Gastroenterology and Surgery Practices." Gastrointest Endosc 101, no. 1 (Jan): 90–102.e1. doi: 10.1016/j.gie.2024.08.016.
