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.
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.
Dr. Peter Forsell, CEO and founder of Implantica, says, “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 reflux1.