Implantica AG has announced the submission of the second clinical module of its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for RefluxStop™, a device designed for the treatment of gastroesophageal reflux disease (GERD). This submission also includes responses to the FDA’s findings from the first module of the PMA application.
RefluxStop™: A Novel Approach to GERD Treatment
RefluxStop™ is designed to address the underlying cause of GERD by surgically restoring the natural physiological function of the lower esophageal sphincter. Unlike traditional treatments such as Nissen fundoplication, which involves encircling the esophagus, RefluxStop™ aims to reconstruct the anti-reflux barrier without applying pressure to the food passageway. This approach may reduce common side effects associated with fundoplication, such as swallowing difficulties and the inability to belch or vomit.
Clinical Evidence and Potential Benefits
The submission is supported by data from a pivotal 5-year study conducted to obtain the CE mark for RefluxStop™. According to Implantica, the study demonstrated that RefluxStop™ not only treats acid reflux more effectively but also exhibits substantially reduced complication rates compared to the standard Nissen fundoplication procedure. Nearly 1,000 patients have been treated with RefluxStop™ across more than 35 centers in Europe.
Addressing a Significant Unmet Need
GERD affects approximately 27% of the adult population in the U.S., and a significant proportion of these patients, around 40%, do not respond adequately to proton pump inhibitors (PPIs), the most common medication used to manage the condition. RefluxStop™ offers a potential alternative by eliminating the need for PPIs to manage GERD symptoms, as demonstrated in the 5-year CE mark study.
Expert Commentary
Dr. Peter Forsell, CEO of Implantica, highlighted the enthusiasm for RefluxStop™ among surgeons, noting the device's potential to become the standard of care for GERD patients in the U.S., pending FDA approval. He also expressed gratitude to the FDA for allowing Implantica to participate in the expedited module process, based on the excellent 5-year clinical results from the RefluxStop™ CE mark study.
