Updated ASGE Clinical Practice Guideline Includes TIF 2.0 and cTIF for Management of GERD
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.
Merit Medical Systems (NASDAQ: MMSI) ha annunciato che la Società Americana di Endoscopia Gastrointestinale (ASGE) ha aggiornato le sue linee guida cliniche per includere la Fundoplicatio Transorale Senza Incisione (TIF 2.0) e le procedure cTIF come approcci basati su evidenze per la gestione del GERD.
Il dispositivo EsophyX Z+ dell'azienda è progettato per queste procedure, che aiutano a ripristinare l'anatomia e ricostruire la valvola gastroesofagea. Uno studio multicentrico recente ha mostrato risultati impressionanti con un tasso di successo clinico del 94% e miglioramenti significativi nella soddisfazione dei pazienti, passando dall'8% al 79%.
Il GERD, che colpisce circa il 20% degli americani, si verifica quando l'acido dello stomaco fluisce nell'esofago. Le linee guida aggiornate dell'ASGE suggeriscono il TIF per i pazienti con piccole ernie iatali (≤2 cm) e cTIF o terapia chirurgica per quelli con ernie più grandi (>2 cm), sulla base di una revisione multidisciplinare.
Merit Medical Systems (NASDAQ: MMSI) anunció que la Sociedad Americana de Endoscopia Gastrointestinal (ASGE) ha actualizado sus guías clínicas para incluir la Fundoplicación Transoral Sin Incisión (TIF 2.0) y los procedimientos cTIF como enfoques basados en evidencia para el manejo de la ERGE.
El dispositivo EsophyX Z+ de la compañía está diseñado para estos procedimientos, que ayudan a restaurar la anatomía y reconstruir la válvula gastroesofágica. Un reciente estudio multicéntrico mostró resultados impresionantes con una tasa de éxito clínico del 94% y mejoras significativas en la satisfacción del paciente, pasando del 8% al 79%.
La ERGE, que afecta aproximadamente al 20% de los estadounidenses, ocurre cuando el ácido del estómago fluye hacia el esófago. Las guías actualizadas de la ASGE sugieren TIF para pacientes con pequeñas hernias hiatales (≤2 cm) y cTIF o terapia quirúrgica para aquellos con hernias más grandes (>2 cm), basándose en una revisión multidisciplinaria.
Merit Medical Systems (NASDAQ: MMSI)는 미국 소화기 내시경학회(ASGE)가 임상 지침을 업데이트하여 경구 무절개 위식도 접합술(TIF 2.0) 및 cTIF 절차를 GERD 관리의 근거 기반 접근법으로 포함시켰다고 발표했습니다.
회사의 EsophyX Z+ 장치는 이러한 절차를 위해 설계되어 있으며, 해부학을 복원하고 위식도 밸브를 재구성하는 데 도움을 줍니다. 최근 다기관 연구에서는 94%의 임상 성공률과 환자 만족도가 8%에서 79%로 증가한 인상적인 결과를 보여주었습니다.
GERD는 약 20%의 미국인에게 영향을 미치며, 이는 위산이 식도로 흘러 들어갈 때 발생합니다. 업데이트된 ASGE 지침은 작은 식도열공탈장(≤2 cm) 환자에게 TIF를, 더 큰 탈장(>2 cm) 환자에게는 cTIF 또는 수술 치료를 제안합니다. 이는 다학제적 검토를 기반으로 합니다.
Merit Medical Systems (NASDAQ: MMSI) a annoncé que la Société Américaine d'Endoscopie Gastro-Intestinale (ASGE) a mis à jour ses lignes directrices cliniques pour inclure la Fundoplicature Transorale Sans Incision (TIF 2.0) et les procédures cTIF comme approches basées sur des preuves pour la gestion du RGO.
Le dispositif EsophyX Z+ de l'entreprise est conçu pour ces procédures, qui aident à restaurer l'anatomie et à reconstruire la valve gastro-œsophagienne. Une récente étude multicentrique a montré des résultats impressionnants avec un taux de succès clinique de 94% et des améliorations significatives de la satisfaction des patients, passant de 8% à 79%.
Le RGO, qui affecte environ 20% des Américains, se produit lorsque l'acide gastrique remonte dans l'œsophage. Les lignes directrices mises à jour de l'ASGE suggèrent le TIF pour les patients présentant de petites hernies hiatales (≤2 cm) et le cTIF ou une thérapie chirurgicale pour ceux ayant des hernies plus grandes (>2 cm), sur la base d'une revue multidisciplinaire.
Merit Medical Systems (NASDAQ: MMSI) gab bekannt, dass die American Society for Gastrointestinal Endoscopy (ASGE) ihre klinischen Richtlinien aktualisiert hat, um die Transorale Inzisionsfreie Fundoplikation (TIF 2.0) und cTIF-Verfahren als evidenzbasierte Ansätze zur Behandlung von GERD aufzunehmen.
Das EsophyX Z+ Gerät des Unternehmens ist für diese Verfahren konzipiert, die helfen, die Anatomie wiederherzustellen und die gastroösophageale Klappe zu rekonstruieren. Eine aktuelle multizentrische Studie zeigte beeindruckende Ergebnisse mit einer 94% klinischen Erfolgsquote und signifikanten Verbesserungen der Patientenzufriedenheit von 8% auf 79%.
GERD, das etwa 20% der Amerikaner betrifft, tritt auf, wenn Magensäure in die Speiseröhre fließt. Die aktualisierten ASGE-Richtlinien empfehlen TIF für Patienten mit kleinen Zwerchfellhernien (≤2 cm) und cTIF oder chirurgische Therapie für Patienten mit größeren Hernien (>2 cm), basierend auf einer interdisziplinären Überprüfung.
- 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
- None.
Insights
The ASGE's inclusion of TIF 2.0 and cTIF procedures in its updated clinical practice guidelines marks a significant clinical validation milestone for Merit Medical's EsophyX Z+ technology. This formal recognition legitimizes these procedures as evidence-based approaches for GERD management, providing the crucial third-party endorsement that often drives widespread clinical adoption.
The clinical evidence supporting this guideline update is compelling. The referenced multicenter study demonstrated a
With GERD affecting approximately
Inclusion in clinical guidelines typically drives three key commercial benefits: increased physician adoption, expanded insurance coverage, and improved reimbursement pathways. This positions Merit's EsophyX Z+ Device as a standard of care option for appropriate GERD patients seeking alternatives to lifelong medication or more invasive surgical approaches - a meaningful competitive advantage in the gastrointestinal endoscopy market.
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
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
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.
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CONTACTS
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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)?
How does Merit Medical's EsophyX Z+ Device treat GERD symptoms?
What patient criteria did ASGE establish for Merit Medical's TIF 2.0 procedure?
What improvement in patient satisfaction was reported for Merit Medical's TIF 2.0 procedure?
