Novel GERD Device Demonstrates Long-Term Safety in Real-World Study

Gastroesophageal reflux disease affects over 1 billion people worldwide, and many patients ultimately require procedural management. Surgical options exist but may introduce adverse effects such as dysphagia, odynophagia, or inability to belch or vomit. Long-term safety data are essential to inform procedure selection and patient counseling. Now, a new device now demonstrates large-scale, long-term safety outcomes in routine practice.

Implantica AG’s RefluxStop is a CE-marked device designed to prevent gastroesophageal reflux. The device’s real-world safety outcomes in 602 patients treated across 22 centers in six European countries, with follow-up of up to 6.75 years, have been published in Scientific Reports. The publication represents the most comprehensive assessment of the implant’s long-term safety reported to date.

Unlike long-established procedures that apply a circumferential constraint, the device does not encircle the esophagus or place pressure on the food passageway. Instead, it restores and maintains the lower esophageal sphincter in its original, natural position. Its mechanism focuses on reconstructing all three components of the anti-reflux barrier to support the body’s natural anatomical physiology. The company reports that the implant is CE-marked for the prevention of gastroesophageal reflux, while U.S. market entry remains pending Food and Drug Administration (FDA) approval.

A multi-center real-world safety analysis, “Safety outcomes in 602 GERD patients treated by RefluxStop: a multi-center real-world study from 22 centers across six European countries,” has been published in Scientific Reports. The study includes follow-up of up to 6.75 years and represents the most comprehensive assessment of the device’s long-term safety to date. Results were also presented at the 2025 American Foregut Society Meeting.

Key findings report that more than 98% of patients experienced no serious safety issues requiring reoperation. All events were resolved satisfactorily in all patients. Reoperation occurred primarily for recurrence of the repaired hiatal hernia in 1.33% of patients, accounting for two-thirds of reoperations; recurrence rates in standard-of-care surgical procedures are described as approximately tenfold higher than observed in this study. All other serious events occurred only in 1 of 602 patients and were mainly associated with the learning curve of a new surgical procedure.

“As we close in on FDA approval of RefluxStop, real-world data confirming previously reported excellent outcomes is more important than ever. I strongly believe the accumulated clinical evidence positions RefluxStop to drive a paradigm shift in the treatment of GERD worldwide,” said Dr. Peter Forsell, inventor of RefluxStop and Founder and CEO of Implantica.

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