Implantica Continues US Approval Process for RefluxStop, Releases New European Studies
Implantica has submitted its final response to the US FDA regarding RefluxStop's premarket approval application. The company also released new cost-effectiveness studies for the device in Europe.
Implantica, a medical technology company, has advanced its application process for the RefluxStop device in the United States. The company has submitted its final response to the U.S. Food and Drug Administration (FDA) concerning Module 3 of the Premarket Approval (PMA) application.
RefluxStop, designed to treat acid reflux, already holds CE marking in Europe and is available in several countries including Germany, the United Kingdom, Switzerland, Spain, Italy, France, Austria, Sweden, and Norway. The device is not yet available for sale in the USA.
Further updates emerge from European research. A health economics study conducted in Italy demonstrates RefluxStop's cost-effectiveness compared to current treatments for GERD. Additionally, long-term data presented at Digestive Disease Week (DDW) 2026 in Switzerland highlighted the device's safety and efficacy, even in complex patient cases.
Implantica is awaiting the FDA's decision regarding market approval in the U.S. The company aims to enhance treatment options for individuals suffering from acid reflux through advanced medical technology.