>1,500
procedures performed in European centers
as of the end of 2025
RefluxStop: international clinical experience
A summary of the international evidence base for the RefluxStop implant (Implantica AG), the reference foreign counterpart of the Reflux Control system: clinical efficacy, regulatory status, adoption, and health economics.
9 countries
in Europe where RefluxStop is available
Germany, United Kingdom, Switzerland, Spain, Italy, France, Austria, Sweden, Norway
>50
implanting centers across Europe
≈35
peer-reviewed articles
published or accepted for publication by the end of 2025
~2%
persistent dysphagia at 5 years
versus 22-45% after Nissen fundoplication and 15-30% after LINX/MSA
5 years
of follow-up in the pivotal trial
0% explantations, migrations, erosions, or dilatations
What RefluxStop is
RefluxStop is an implantable, non-active, single-use silicone device for the surgical treatment of gastroesophageal reflux disease (GERD). It is manufactured by Implantica AG (Vaduz, Liechtenstein / Zug, Switzerland), listed on Nasdaq First North (ticker IMP A SDB); the founder, CEO, and inventor is Dr. Peter Forsell.
The device is placed laparoscopically into an invaginated pouch created from the gastric fundus, outside the esophagus, without encircling or compressing it. The procedure restores all three components of the antireflux barrier: the angle of His (the flap-valve mechanism), the position of the lower esophageal sphincter below the diaphragm, and the integrity of the diaphragmatic crura (crural repair). The implant acts as a mechanical stop that keeps the sphincter in its abdominal position.
Avoiding any encirclement of the esophagus is precisely what explains the low rates of dysphagia and gas-bloat syndrome compared with fundoplication and the magnetic ring (LINX/MSA): the device exerts no compression on the food passageway.
Regulatory status
European Union · CE mark
ApprovedCE mark granted in August 2018 based on the 6-month data of the pivotal trial (50 patients).
United States · FDA PMA
Under reviewModular PMA submission completed: positive feedback on the clinical module (Feb 2025), 6 pre-approval inspections passed (Q4 2025), final response submitted May 20, 2026. Not approved as of the data-collection date; US launch preparation is under way.
United Kingdom · NICE
Positive guidanceIPG803, June 2025: recommended for use in the NHS for patients with ineffective esophageal motility (IEM), which Implantica estimates at up to 40-50% of all GERD patients.
Clinical evidence base
Pivotal trial (CE mark trial, NCT02759094)
A prospective, single-arm, multicenter (4 sites) trial in 50 adults with chronic GERD; surgeries December 2016 to September 2017; follow-up out to 5 years. Exclusion criteria: hiatal hernia >3 cm, LA grade C/D esophagitis, BMI >35, previous esophageal or gastric surgery.
| Time point | GERD-HRQL (quality of life) | 24-h pH monitoring (time pH<4) | PPI use | Dysphagia / device |
|---|---|---|---|---|
| Baseline | 29.5 (median) | 16.35% | 100% (50/50) | 2 mild cases of dysphagia at baseline |
| 6 months to 1 year Bjelović 2020 | −86% | 0.80% at 6 months normalized in 98% of patients | 2.1% (1/47) | no new cases of dysphagia |
| 3 years | −93.1% (→ 2.0) | normal | 0% (0/47) | dysphagia 1/47 · 0 explantations or dilatations |
| 4 years | −90% (→ 3.0) | normal | 2/44 with normal pH monitoring | dysphagia 1/47 · 0 migrations or explantations |
| 5 years 2025, mean 5.7 years | −90% (→ 3.0) | −90.4% (→ 1.57%) | 2.1% (1/47) | 0% explantations, migrations, erosions, dilatations, or recurrent hernias |
Over years 1-5, only 2 procedure-related adverse events were recorded (dyspepsia and mild dysphagia); both resolved.
A dedicated publication on food-passageway sequelae at 5 years: freedom from adverse dysphagia in 97.9%, freedom from odynophagia in 97.9%, gas-bloating absent or improved in 95.7%, and the ability to belch and vomit preserved in 100% of patients.
The 1-, 3-, 4-, and 5-year publications are sequential reports on a single cohort of 50 patients (44 completed the 5-year visit), not independent studies.
Real-world clinical experience
602 patients · 22 centers · 6 countries
The largest real-world safety study (Germany, Switzerland, Spain, Italy, United Kingdom, Austria); mean follow-up 2.0 years, maximum 6.75 years. Serious outcomes and reoperations: 1.99% (12/602), all resolved; two thirds were recurrent hernias caused by crural-repair disruption, unrelated to the device. Asymptomatic erosion 0.66% (early phase, learning curve), explantations 0.5%, dilatation in 1 patient; 21 of 22 centers reported no dilatations at all. Retrospective design.
First meta-analysis: 296 patients
5 studies. GERD-HRQL 27.96 → 3.89; patient satisfaction 93.9%. Overall complication rate 15.2%, mostly self-limiting surgical emphysema; 9.1% without it, and severe complications (Clavien-Dindo 3-4) at 3%.
n=158: GERD-HRQL −90.9% at 2 years
An independent study from two German centers: ≈96% of patients discontinued PPIs, in a cohort that included 22% large hernias, 44% esophagitis, and 10% Barrett's esophagus.
n=28: complete symptom resolution
The Elshafei series, mean follow-up 14 months: all preoperative heartburn, regurgitation, and dysphagia resolved.
n=99: large hernias without added risk
Large (4-10 cm) versus small (≤3 cm) hiatal hernias: no significant difference in adverse-event rates; GERD-HRQL −93.8% (large) and −85.7% (small). For context, standard surgery in large hiatal hernias carries up to 50% reoperation rates over 5 years.
Adoption and commercialization
By the end of 2025, RefluxStop was in use at more than 50 European centers, with over 1,500 procedures performed and roughly 35 peer-reviewed articles published or accepted for publication.
Available in 9 European countries:
GermanyUnited KingdomSwitzerlandSpainItalyFranceAustriaSwedenNorway
Spain 20 centers since 2023
Within about 3 years of launch, 20 centers have opened; the twentieth is MD Anderson Cancer Center Madrid-Hospiten (June 2026), part of a US hospital group. The first public tender for RefluxStop in Spain was won at Hospital Universitario de Getafe (Madrid). GERD affects 15% of Spanish adults.
Italy 400+ implantations
Public tenders worth over €2.3 million (including Palermo and Brunico); RefluxStop and magnetic rings are reimbursed at the fundoplication level.
Germany on the path to DRG
A dedicated procedure code (OPS) has been granted; inclusion in the DRG tariff via the INEK institute is in progress and requires more than 200 procedures from reporting hospitals. The center network keeps growing: Klinikum St. Georg (Leipzig), St. Vincenz (Menden), and others. GERD costs Germany roughly €688 million in lost GDP every year.
United Kingdom NICE IPG803
Positive NICE guidance opened use in NHS public hospitals (Chelsea & Westminster and others); national user meetings for surgeons are being held. About 9.5 million people in the country live with GERD.
United States launch preparation
After the FDA decision, the launch is planned to start with about 50 centers supported by ~40 key opinion leaders; payer dossiers have been prepared and in-house manufacturing is in place.
Health economics
In every published country model, RefluxStop is cost-effective, and against the surgical alternatives (Nissen fundoplication, LINX/MSA) it frequently dominates: cheaper and more effective at the same time. The models are Markov models with a lifetime horizon and QALY as the outcome metric.
| Country / model | RefluxStop ICER (per QALY) | Probability of cost-effectiveness |
|---|---|---|
| United Kingdom York Health Economics Consortium | vs PPI £4,156 · vs Nissen £6,517 · vs MSA £249 | at a £20k threshold: 100% / 93% / 100% |
| Switzerland J Med Econ, 2024 | vs PPI CHF 2,116; dominates Nissen and MSA | at a CHF 100k threshold: 100% / 97% / 100% |
| Italy BMC Gastroenterology, 2026 | vs medical management €3,067 · vs Nissen €6,712 · vs MSA €171 | at a €50k threshold: highly cost-effective against all alternatives |
| Norway Cost Eff Resour Alloc, 2025 | vs PPI NOK 68,262 · vs Nissen NOK 79,543 improving to NOK 55,167 / 48,914 with 5-year data and the n=602 cohort | at a NOK 275k threshold: 100% / 92% |
| Sweden · Spain · United States ISPOR 2025, Medicare | cost-effective against both surgery and medical therapy | Spain: publication under peer review |
Cost context: in Italy, GERD affects ~6.5 million people with direct costs of €1.76 billion per year; in Switzerland, CHF 230 million per year (mostly PPIs). Up to 30-40% of patients do not get adequate relief on PPIs, and long-term PPI use is associated with renal and cardiovascular risks, fractures, infections, and gastric cancer.
Comparison with alternatives
An indirect comparison of long-term RefluxStop outcomes with Nissen fundoplication and the LINX/MSA magnetic ring, based on published data.
| Outcome (long-term data) | RefluxStop | Nissen (fundoplication) | LINX / MSA (magnetic ring) |
|---|---|---|---|
| Persistent dysphagia | ~2% (5 years) | 22-45% | 15-30% |
| Gas-bloating | absent or improved in 95.7% | ~31-53% | ~27-53% |
| Inability to belch / vomit | 0% | 39.8% | better preserved than after Nissen |
| Endoscopic dilatations | ~0 | ~16% | 13-31% |
| Device explantation | ~0.5% | n/a | 4-13% |
| Reoperations | <2% | 7-16% (up to 10 years) | ~10% (1 year) |
| PPI use after surgery | 2% | 12-23% | 12-21% |
Ranges for Nissen and MSA come from the Italian health-economic model (BMC Gastroenterology, 2026), a systematic review of 63 RCTs on fundoplication (cited in the 5-year RefluxStop publication), and the Nature n=602 cohort; short-term LINX vs Nissen figures from the meta-analysis PMID 27981382; overview context from a narrative review of four methods (2025).
Sources
The peer-reviewed publications and official documents this page is built on (DOI, PMID, PMCID). Data collected in August 2026.
Clinical studies: pivotal and real-world
BMC Surgery · 2020
Non-active implantable device treating acid reflux: 1-year results (CE mark trial)
Digestive Diseases and Sciences · 2024RefluxStop: 3-year outcomes
Surgical Endoscopy · 2024Treating acid reflux without compressing the food passageway: 4-year outcomes
Surgical Endoscopy · 2025Five-year clinical outcomes of RefluxStop surgery
Surgical Endoscopy · 2025Food passageway-related sequelae at 5 years after RefluxStop
Nature Scientific Reports · 2026Safety outcomes in 602 GERD patients treated by RefluxStop
J Gastrointest Surg · 2026Safety and clinical outcomes of RefluxStop: systematic review and meta-analysis
Surg Endosc · SwitzerlandRefluxStop in small versus large hiatal hernias (n=99, up to 4 years)
J Laparoendosc Adv Surg TechThe Elshafei series, Germany (n=28): resolution of all preoperative symptoms
Implantica · AUGIS 2024Independent study of 158 patients from two German centers (2 years)
ClinicalTrials.govPivotal trial registration NCT02759094
Health economics
PubMed · United Kingdom
RefluxStop cost-effectiveness analysis (York Health Economics Consortium)
JHEOR · 2024RefluxStop budget impact analysis for the NHS (United Kingdom)
J Med Econ · 2024RefluxStop cost-effectiveness analysis, Switzerland
BMC Gastroenterology · 2026RefluxStop cost-effectiveness analysis, Italy
PharmacoEconomics-Open · 2024RefluxStop budget impact analysis, Italy
Cost Eff Resour Alloc · 2025RefluxStop cost-effectiveness analysis, Norway
Comparison of surgical methods
Regulatory, adoption, corporate reporting
Implantica · June 2025
NICE publishes positive IPG803 recommendations for the NHS
Implantica · May 2026Final response to the FDA in the PMA application for US market approval
Implantica · June 2026Launch of the 20th RefluxStop center in Spain (MD Anderson Madrid-Hospiten)
Implantica · 2024Public tender win: Hospital Universitario de Getafe (Spain)
Implantica · annual reportAnnual Report 2025 (PDF)
Implantica · Q1 2026Interim report January-March 2026