ASGE更新指南:TIF 2.0及cTIF治療GERD新選擇




更新ASGE臨床實踐指引,包括TIF 2.0和cTIF以管理GERD

內窺鏡抗反流療法被認可為緩解GERD症狀的循證方法。

2025年3月27日,南喬丹,猶他州(GLOBE NEWSWIRE)——全球醫療技術領導者Merit Medical Systems, Inc.(NASDAQ: MMSI)今日宣布,美國消化內視鏡學會(ASGE)更新了其有關胃食道逆流病(GERD)診斷和管理的指引,將經口無切口胃底折疊術(TIF 2.0)和TIF 2.0連續經口無切口胃底折疊術(cTIF)程序納入循證護理方法。

GERD是指胃酸流入食道,導致食道內襯組織受到刺激。常見的不適症狀包括胸口灼熱感、上腹部或胸部疼痛、吞嚥困難和慢性咳嗽。作為一種常見的慢性病,GERD影響約20%的美國人。若不治療,GERD可能隨著時間推移導致其他嚴重併發症。

TIF 2.0是一種微創療法,旨在重建胃食道瓣膜並恢復其作為反流屏障的功能。此外,TIF 2.0還可以與手術性膈疝修補術連續結合,形成cTIF程序。

為了診斷和管理GERD,ASGE使用建議評估、發展和評估框架制定了循證指引。這一更新源於2014年的ASGE指引,修訂後的指引強調了內窺鏡抗反流療法在GERD管理和治療中的作用,包括TIF 2.0和cTIF程序。

ASGE標準實踐委員會及其共同作者表示:“對於確診為GERD且有小型膈疝(≤ 2 cm)和Hill I或II級的患者,ASGE建議評估TIF作為慢性藥物管理的替代方案。對於持續性GERD且有大型膈疝(> 2 cm)和Hill III或IV級的患者,ASGE建議根據多學科評估選擇cTIF或外科治療。”

“ASGE實踐指引的最新更新對於正在遭受GERD困擾的患者來說是一個重要的里程碑。我們了解到TIF 2.0和cTIF都是安全且有效的,現在有了1級證據來證明這一點,這也促成了社會的認可,”加州新港海灘Hoag消化健康研究所的執行醫療主任及消化科醫生Kenneth Chang表示,他也是Merit TIF醫生教育課程的創始成員。“臨床證據不斷增強,最近一項針對85名患者的前瞻性多中心隊列研究顯示,TIF 2.0後的臨床成功率達94%;89%的患者GERD健康相關生活質量分數改善;85%的基線升高的反流症狀指數得以正常化;患者滿意度從8%提高至79%(P < .0001)。沒有出現與TIF 2.0相關的嚴重不良事件。預期隨著這一進展,更多符合條件的患者將能夠接受TIF 2.0或cTIF程序。”

為了幫助治療這一患者群體,Merit Medical提供EsophyX® Z+裝置,用於TIF 2.0和cTIF程序。該裝置旨在恢復解剖結構並重建胃食道瓣膜,幫助緩解GERD症狀,減少可能導致長期併發症和風險的酸性反流。EsophyX Z+裝置配備SerosaFuse快速固定器和配件,適用於消化道的經口組織近似、全層摺疊和結紮,並適用於需要和對藥物療法有反應的症狀性慢性胃食道逆流病患者。它也適用於在症狀性慢性胃食道逆流病患者中縮小接合部並減少膈疝≤2cm的大小。對於膈疝大於2cm的患者,當腹腔鏡膈疝修補術將膈疝減少至2cm或更小時,也可以納入。

對EsophyX Z+裝置的更多了解。

“我們很高興看到TIF和cTIF程序獲得應有的關注,成為治療GERD的循證方法,”Merit的主席兼首席執行官Fred P. Lampropoulos表示。“通過我們的EsophyX Z+技術,我們期待幫助醫生為更多患者提供這一標準護理。”

關於Merit

Merit Medical Systems, Inc.成立於1987年,專注於開發、製造和分銷專有醫療設備,這些設備用於介入、診斷和治療程序,特別是在心臟病學、放射學、腫瘤學、重症護理和內窺鏡領域。Merit在全球擁有超過800人的國內和國際銷售團隊及臨床支持團隊,為客戶提供服務。Merit在全球約有7400名員工。

商標

除非另有說明,否則本公告中使用的商標和註冊商標均為Merit Medical Systems, Inc.及其子公司或授權方的財產。

聯繫方式
公關/媒體查詢
Sarah Comstock
Merit Medical
+1-801-432-2864 | sarah.comstock@merit.com

投資者查詢
Mike Piccinino, CFA, IRC
Westwicke – ICR
+1-443-213-0509 | mike.piccinino@westwicke.com

*Merit Medical將“cTIF”定義為連續經口無切口胃底折疊術,包括在單一麻醉下進行的膈疝修補(HHR)隨後進行的經口無切口胃底折疊術(TIF)程序。

這篇報導展示了最新的ASGE指引更新,突顯了TIF 2.0和cTIF在治療GERD方面的科學依據和臨床有效性。這不僅對患者的治療選擇提供了新的希望,也顯示了醫療技術的進步如何能改善患者的生活質量。隨著這些新技術的推廣,未來的臨床實踐可能會更注重個性化治療,讓更多患者受益。這一變化也提醒我們,持續的臨床研究和數據收集對於推動醫療進步至關重要。

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