EndoGastric Solutions

a leader in the endoluminal treatment of digestive diseases

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Data

Clinical Study Data

To date, the TIF procedure with the EsophyX® device has been performed in more than 22,000 patients worldwide. More than 100 peer-reviewed papers from over 75 centers have been published documenting consistent outcomes in over 1,500 unique study patients. The clinical study data demonstrate:

  • Significant control of reflux and improvement in quality of life
  • Elimination of daily PPI therapy in 75% of patients
  • Esophagitis completely healed in 82% of patients post TIF procedure

Throughout existing clinical experience and forthcoming clinical studies, results continue to demonstrate that the TIF procedure:

  • Reconstructs the anatomy and function of the gastroesophageal junction
  • Provides clinical efficacy across a range of outcomes measurements including symptoms and quality of life scores, cessation of PPI therapy, pH-metry changes, and LES pressure

Safety

Throughout both clinical publications and broader commercial experience, the TIF procedure has maintained an excellent safety profile with minimal post‐operative side‐effects such as gas bloat and dysphagia.

  • Rate of post‐fundoplication Serious Adverse Events (SAE) are consistently very low; reported as 2.75% in all clinical publications
  • SAE rate in more than 22,000 TIF procedures performed commercially worldwide is < 0.43% (94 in 22,000 commercial cases); last SAE reported July 2019

Data: TIF Procedure Objective Measures

References for studies sited in weighted average calculations

NP02410-05A
NP02450-01F

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This site is published by EndoGastric Solutions, Inc., and is intended as an information resource to help increase awareness of GERD-related disorders and the available treatment options. This site is not a substitute for medical advice from your physician. The contents of the site are for informational purposes only and are intended to be discussed with your physician. Never disregard any advice given to you by your physician or other qualified healthcare professional. Always seek the advice of a physician or other licensed healthcare professional regarding any questions you have about your medical conditions and treatments.
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© 2019 EndoGastric Solutions, Inc. All rights reserved. EndoGastric, EsophyX, SerosaFuse and TIF names and logos, are registered trademarks of EndoGastric Solutions.
All other product names and logos are trademarks or registered trademarks of their respective holders.

NP02410-01B

  • Company
    • Overview
    • Management Team
    • Board of Directors
    • Investors
    • Corporate Compliance
    • Careers
  • EsophyX Technology
    • Overview
    • SerosaFuse® Fasteners
    • EsophyX® Device
    • Physician Training & Education for TIF Procedure with EsophyX Device
    • Regulatory Labeling
  • TIF Procedure
    • Overview
    • Society Support
    • TIF vs Antireflux Surgery
    • TIF Procedure Reimbursement
  • Data
    • Overview
    • Bibliography
    • European Bibliography
    • Clinical Research
  • Support
    • Overview
    • Training and Education
    • TIF Procedure Reimbursement
    • Marketing Programs
  • News
    • Press Releases
    • Videos
    • Professional Events
    • Blog
  • Contact
  • Privacy
  • Social Media Policy
  • Terms of Use