Implantica receives FDA approval for RefluxStop GERD implant after eight years since EU launch

Implantica announced that the U.S. Food and Drug Administration has granted approval for its gastroesophageal reflux disease (GERD) implant, RefluxStop, following a rigorous Premarket Approval review.

The device is implanted via minimally invasive keyhole surgery at the upper stomach and is intended to reduce or stop acid from entering the esophagus, offering an alternative to long‑term medication for patients who cannot tolerate drugs.

RefluxStop has been available in Europe since 2018, where the company reports treatment of about 1,800 patients across more than 60 specialized centers. The U.S. market, with an estimated 78 million GERD sufferers, presents a significant opportunity.

The company plans a targeted launch at leading U.S. centers and among experienced reflux surgeons, with expectations that adoption will grow as physicians become familiar with the technology.