Implantica has announced positive two-year results for its RefluxStop device, a novel implant designed for the management of gastro-oesophageal reflux disease (GORD). The study, presented at the Association of Upper Gastrointestinal Surgery (AUGIS) of Great Britain and Ireland 2024 Conference, reveals a significant improvement in the quality of life for patients suffering from this condition.
The study, conducted in Germany, involved 158 patients diagnosed with GORD, a condition characterized by the recurring backflow of stomach acid into the esophagus. This reflux leads to symptoms such as heartburn, bad breath, and nausea, significantly impacting patients' daily lives.
Key Findings on RefluxStop Efficacy
The data revealed that 96.4% of patients in the retrospective analysis were able to discontinue the use of proton pump inhibitors (PPIs), which are the standard of care for GORD. Furthermore, a 90.9% improvement was observed in the GERD-HRQL (Gastroesophageal Reflux Disease Health-Related Quality of Life) score. Notably, many patients in the study presented with complex conditions, including large hiatal hernias, active esophagitis, and precancerous changes, which often complicate GORD treatment.
Dr. Thorsten Lehmann, an author of the study, commented, "This paper shows that RefluxStop could allow me to offer more patients with large hiatal hernia the durable benefits of a surgical treatment for GORD."
RefluxStop Mechanism and Advantages
Unlike existing treatments that typically encircle the esophagus, RefluxStop is designed to reconstruct all three components of the anti-reflux barrier. Implanted near the left side of the esophagus, above the lower esophageal sphincter, the device restores and supports the natural anatomy in the area, effectively reducing acid backflow.
Regulatory and Market Landscape
RefluxStop received CE marking in August 2018, and Implantica is currently pursuing approval from the US Food and Drug Administration (FDA). One of the existing technologies in the market is Johnson & Johnson MedTech’s Linx reflux management system, which received CE marking in 2008 and FDA approval in 2012. The Linx system consists of magnetic titanium beads connected with titanium wires, forming a ring surgically implanted around the lower end of the esophagus.
Implantica’s CEO, Dr. Peter Forsell, expressed confidence in the device, stating that the results are "reassuring that we are on the right path to bring this unique solution to patients as quickly as possible."
These new data build upon previous findings published in Nature journal Scientific Reports in July, which indicated that the device improved or completely resolved symptoms in 90% of patients with ineffective esophageal motility.
