Clinical Study Data
To date, the TIF procedure with the EsophyX® device has been performed in more than 20,000 patients worldwide. More than 80 peer-reviewed papers from over 60 centers have been published documenting consistent outcomes in over 1,300 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 18,000 TIF procedures performed commercially worldwide is < 0.42% (1 in every 250 cases); last SAE reported August 2016
References for studies sited in weighted average calculations