Implantica completes 5-year CE study, prepares FDA submission
Medtech company Implantica has finalized its 5-year CE mark study results and is preparing to submit Module 2 of its Premarket Approval application for RefluxStop™ to the FDA.
Implantica, a medical technology company, has announced the completion of its 5-year pivotal CE mark study for its RefluxStop™ device. The company is now preparing to submit Module 2 of its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA), with submission anticipated in the autumn.
Module 2 is considered the most critical component of the PMA application, containing comprehensive clinical and usability data. This includes the final results from the CE mark clinical investigation and a Human Factors Validation Study conducted earlier this year with U.S. surgeons.
Results from the 5-year CE study indicate that the devices remained in place and functional without dislocation or migration in all participants. Furthermore, 24-hour pH monitoring data showed excellent outcomes, with only one subject reporting dissatisfaction. Implantica highlighted this as a significant improvement compared to a competitor's trial, which reported a 42% failure rate in pH tests within the first year.
CEO Dr. Peter Forsell stated that the results align with previously published data and real-world outcomes in Europe, reinforcing the device's potential as a treatment option for acid reflux sufferers. The company suggests these findings will advance RefluxStop's position in the market.
RefluxStop™ currently holds CE marking in Europe and is available in several countries, including Germany, the United Kingdom, and France. The device is not yet approved for sale in the United States.