Updated ASGE Clinical Practice Guideline Includes TIF 2.0 and cTIF for Management of GERD

Rhea-AI Summary

Merit Medical Systems (NASDAQ: MMSI) announced that the American Society for Gastrointestinal Endoscopy (ASGE) has updated its clinical guidelines to include Transoral Incisionless Fundoplication (TIF 2.0) and cTIF procedures as evidence-based approaches for managing GERD.

The company's EsophyX Z+ Device is designed for these procedures, which help restore anatomy and reconstruct the gastroesophageal valve. A recent multicenter study showed impressive results with a 94% clinical success rate and significant improvements in patient satisfaction from 8% to 79%.

GERD, affecting approximately 20% of Americans, occurs when stomach acid flows into the esophagus. The updated ASGE guidelines suggest TIF for patients with small hiatal hernias (≤2 cm) and cTIF or surgical therapy for those with larger hernias (>2 cm), based on multidisciplinary review.

Positive

• ASGE's inclusion of TIF 2.0 and cTIF in clinical guidelines validates Merit Medical's technology
• Strong clinical evidence with 94% success rate in recent study
• Significant improvement in patient satisfaction from 8% to 79%
• No serious adverse events reported in clinical trials

Negative

• None.

Endoscopic anti-reflux therapy recognized as evidence-based approach to providing relief of GERD symptoms.

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.”

ABOUT MERIT

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.

TRADEMARKS

Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors.

CONTACTS 
PR/Media Inquiries 
Sarah Comstock 
Merit Medical 
+1-801-432-2864 | sarah.comstock@merit.com 

INVESTOR INQUIRIES 
Mike Piccinino, CFA, IRC 
Westwicke - ICR 
+1-443-213-0509 | mike.piccinino@westwicke.com 

^*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.

FAQ

What are the clinical success rates for Merit Medical's TIF 2.0 procedure (MMSI)?

Recent multicenter study showed 94% clinical success rate, with GERD-related quality of life improvements in 89% of patients and no serious adverse events.

How does Merit Medical's EsophyX Z+ Device treat GERD symptoms?

It performs transoral tissue approximation and full-thickness plication to restore anatomy and reconstruct the gastroesophageal valve, reducing acid reflux and GERD symptoms.

What patient criteria did ASGE establish for Merit Medical's TIF 2.0 procedure?

ASGE recommends TIF for GERD patients with small hiatal hernias (≤2 cm) and Hill grade I or II, while suggesting cTIF for larger hernias (>2 cm) and Hill grade III or IV.

What improvement in patient satisfaction was reported for Merit Medical's TIF 2.0 procedure?

Patient satisfaction significantly improved from 8% to 79% according to the recent multicenter study.