First U.S. Procedures Successfully Completed With New GERD Implant

Conventional surgeries that encircle the esophagus to treat gastroesophageal reflux disease (GERD) can be associated with swallowing difficulties, gas bloating, and an inability to belch or vomit. Clinicians continue to seek surgical approaches that correct the anatomical cause of reflux while preserving more natural swallowing function. A new device now offers a method designed to restore the natural anti-reflux barrier without encircling the esophagus.

Implantica’s RefluxStop is an implant designed for the treatment of GERD, and its first commercial procedures in the United States were completed on November 4, 2026, at the University of Southern California (USC) in Los Angeles. The cases represented the initial U.S. use of the system in clinical practice. The milestone expands availability of the therapy to American centers.

RefluxStop is designed to address the root cause of reflux by restoring the body’s natural anti‑reflux barrier. The implant aims to restore and maintain the lower esophageal sphincter (LES) in its natural anatomical position without encircling or applying pressure to the food passageway. By avoiding wrapping or constricting the esophageal sphincter, the approach differs from conventional anti‑reflux procedures that are often linked to adverse effects such as dysphagia, inability to belch or vomit, and gas bloating.

RefluxStop is U.S. Food and Drug Administration (FDA) approved and CE‑marked for the treatment of GERD. Long‑term five‑year clinical outcomes published in peer‑reviewed journals support that a significant portion of patients can achieve clinically meaningful results with minimal risks when the device is used according to its indications for use. Commercial performance from multiple centers is reported to align with study findings and indicates effective GERD control without esophageal constriction and with fewer side effects.

The device is indicated to treat acid and non‑acid reflux in patients diagnosed with GERD. Its intended action is to maintain the gastroesophageal junction in a defined intra‑abdominal position to permit natural physiological function of the LES, thereby reducing or eliminating reflux. A dedicated deployment tool is indicated for patients diagnosed with GERD by abnormal impedance‑pH and/or pH testing who are candidates for RefluxStop implantation.

“With RefluxStop we now have a solution that addresses a significant unmet medical need - not only for the approximately 40% of GERD patients who respond inadequately to medication, but also for the more than one-third of sufferers with swallowing difficulties who have no well working treatment today. For decades, we have sought a treatment that provides effective reflux control without compromising patient's natural swallowing,” said Dr. John C. Lipham, Chief of the Division of Upper GI and General Surgery, Keck School of Medicine of USC and Past President and Co‑founder of the American Foregut Society.

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