This new device is showing some signs of promise in the management of acid reflux.
Below are descriptions from the manufacturer, Implantica, on how it works with an accompanying video.
This 2020 paper in BMC Surgery, Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results, concluded "The new principle of RefluxStop™ is safe and effective to treat GERD according to investigation results. At 1-year follow-up, both the GERD-HRQL score and 24-h pH monitoring results indicate success for the new treatment principle. In addition, with the dynamic treatment for acid reflux, which avoids compressing the food passageway, prevalence of dysphagia and gas bloating are significantly reduced."
This 2022 paper in Surgical technology International, RefluxStop™ Therapy - a New Minimally Invasive Technology in Anti-reflux Surgery found "the initial results, and the rate of side effects compared to Nissen fundoplication are described. Implantation of the CE-certified RefluxStop™ has been used for 3 years and the initial studies show encouraging success rates. In addition, side effects are significantly reduced."
A June 2023 study published in British Journal of Surgery, RefluxStop – A Novel Device to Address Gastroesophageal Reflux Disease in the Context of Esophageal Hypomotility concluded, "RefluxStop shows promising results over four years in a challenging patient population burdened with GERD and esophageal motility disorders."
An August 2023 article in Diseases of the Esophagus, RefluxStop – A Novel Device to Address Gastroesophageal Reflux Disease in the Context of Esophageal Hypomotility concluded, "This study adds to a growing body of evidence that the RefluxStop procedure is safe and effective in management of GERD patients. Notably, a considerable improvement in PPI usage and health-related quality of life parameters were appreciated. Additional studies are required to further validate the role of this procedure in disease management."
In a panel discussion at the 2023 meeting of the American Foregut Society, Dr. Lehmann, Center Director and Chief Physician of the Clinics for General and Visceral Surgery Friedrichshafen & Tettnang, Germany and who has performed more than 120 RefluxStop procedures, said, "By not encircling the esophagus, RefluxStop provides negligible dysphagia in GERD patients."
This 2024 paper pubblished in Scientific Reports, "Multicentric short term and safety study of ineffective esophageal motility patients treated with RefluxStop device" concluded, "the RefluxStop device is a promising new technology for the treatment of GERD. Given its minimally invasive nature and potential advantages for patients with esophageal motility disorders, initial findings suggest a low incidence of complications and quick recovery time during short-term follow-up. However, further studies and longer follow-up are necessary to prove long-lasting positive effects as a novel anti-reflux procedure."
However, "Two severe adverse events need mentioning: one postoperative slipping of the RefluxStop with need of immediate revisional operation on the first postoperative day (Clavien–Dindo Score 3b) and one device migration with no necessary further intervention."
A paper published in Surgery Open Science January 2025, looked at the clinical outcomes of 79 German recipients concluding: "Analysis of this cohort that underwent RefluxStop surgery indicates excellent safety and effectiveness over this short-term follow-up. Significant improvements in quality of life and PPI use were observed in a population where half had either large hiatal hernia >3 cm or reoperation for previously failed antireflux surgery, a demographic with usually much higher complication rates."
"Results of 28 patients in a Retrospective Analysis" published in March 2025 concluded, "RefluxStop provides excellent safety and effectiveness outcomes for GERD treatment. Dysphagia completely resolved (0%) with 88.6% improvement in median GERD-HRQL score and satisfaction achieved in 96.4% of patients."
This device is not yet available in US. (2024)
From Implantica, "The RefluxStop is approved (CE Marked) for commercial use in Europe. The procedure is currently performed only in a few countries in Europe, where the necessary pre& post-surgery care is provided to patients. Implantica is currently working on making RefluxStop available globally, however, it is difficult to estimate the timing for approval in each specific country. We are working on US FDA clearance, but not there yet."
The device won Medtop Tech's Most Innovative Device Category Award in 2023, described here.
Page update 14 April 2025