The approval allows Implantica to begin commercial launch activities in the United States, the world’s largest medical device market, it states.

“FDA approval represents a transformational milestone for Implantica and follows the FDA’s full review of the RefluxStop PMA application, including the long-term clinical evidence supporting the 5-year safety and effectiveness of the therapy,” the company states.

“FDA approval of RefluxStop is a defining landmark for Implantica and the culmination of many years of clinical development, scientific work, and rigorous regulatory review. Most importantly, it means that we can now bring RefluxStop to the United States, where an estimated 78 million people suffer from acid reflux,” says Dr. Peter Forsell, CEO and founder of Implantica.

RefluxStop is designed to address the underlying cause of acid reflux by restoring and maintaining the natural anatomy of the gastroesophageal junction, without encircling or applying pressure on the food passageway.