Toinen julkaisu RefluxStopin viiden vuoden seurannan tuloksista. Eihän tässä voi kuin odotella FDA hyväksynnän tuloksia, jotka toivottavasti tulee tässä lähiaikoina (autumn).
Implantica announces second publication of groundbreaking 5-year results from the landmark RefluxStop® clinical study
07.08.2025
| Non regulatory
Implantica AG (publ), a leading medtech company pioneering advanced implantable medical technologies, today announced the second peer-reviewed publication of the remarkable 5-year outcomes from its CE mark clinical study of RefluxStop®, a revolutionary device for the treatment of acid reflux—a condition affecting over 1 billion people worldwide.
The newly released publication focuses on long-term safety and effectiveness outcomes and complements the earlier 5-year report on food passageway-related outcomes. Both studies were published in the prestigious journal Surgical Endoscopy, jointly produced by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the European Association for Endoscopic Surgery (EAES).
The second publication, titled “Five-year clinical outcomes of RefluxStop surgery in the treatment of acid reflux: A prospective multicenter trial of safety and effectiveness,” provides the ultimate validation of RefluxStop®’s consistent and outstanding clinical performance. Key highlights include:
97.9% of patients were free from proton pump inhibitor (PPI) medication use at 5 years, compared to 100% of patients taking PPIs pre-RefluxStop® surgery.
No device-related adverse events reported over the entire 5-year study period.
Quality of life (GERD-HRQL scores) improved by a median of 90% (IQR), p<0.001.
Acid exposure time in lower essophagus (24h pH monitoring), the only objective acid reflux measure, improved by 90.4%, p<0.001.
Access the 5-year full publications:
Effectiveness & Safety Outcomes
Food Passageway Outcomes
Dr. med. Joerg Zehetner of Klinik Beau-Site, Bern, Switzerland, who presented the study’s findings at the SAGES Scientific Conference in California, says:
“RefluxStop® has demonstrated truly stellar results that significantly improve the quality of life for GERD patients. As a surgeon who has treated thousands of patients in Switzerland from all over the world, the safety profile is paramount to me—and this study confirms RefluxStop® as the safest and most effective surgical option for acid reflux sufferers available today. Over five years, there were no complications such as reherniations, migrations, or dislocations—confirmed via contrast-swallow imaging.”
Dr. Zehetner further noted the superior patient experience:
“It is very encouraging to see that RefluxStop has maintained its crucial anatomical position over time, resulting in excellent sustained long-term patient outcomes. Importantly, RefluxStop® uniquely restores the body’s natural anti-reflux barrier—offering unmatched long-term outcomes and safety as shown in this study. Also, postoperative swallowing difficulties were virtually eliminated—no patients required esophageal dilatation during the study, offering a major advantage compared to traditional GERD surgeries.”
Dr. Peter Forsell, founder and CEO of Implantica, added:
“These 5-year results confirm RefluxStop®’s strong potential to redefine the standard of care in GERD surgery. With nearly 50 RefluxStop® Centers of Excellence established across Europe, Implantica is rapidly growing its clinical and commercial infrastructure to support broader adoption. The company is now preparing for its U.S. market launch, pending FDA approval. As we approach the U.S. launch, we believe RefluxStop® is uniquely positioned to become the gold standard in surgical GERD treatment—offering superior patient outcomes, safety, and long-term cost-effectiveness.
With FDA approval pending, global expansion underway, and increasing clinical momentum, we are focused on unlocking significant value for patients, providers, and shareholders alike.”