Implantica completes Human Factors Validation Study for RefluxStop™ as part of the US FDA Premarket Approval Process
Implantica AG (publ.), a medtech company at the forefront of bringing advanced technology into the body, announces completion of the Human Factors Validation Study with 16 US surgeons as part of the US FDA Premarket Approval (PMA) process for RefluxStop™.In March, 16 foregut surgeons in the United States (U.S.) participated in a Human Factors Validation Study of the RefluxStop™ procedure at Northwestern University’s Simulation Lab in Chicago. RefluxStop™ is an innovative new surgical procedure for the treatment of gastroesophageal reflux disease (GERD).
The goal of the study is to