EndoStim has implanted first patient with the EndoStim device in its lower esophageal sphincter stimulation for GERD (LESS GERD) clinical trial.
The trial will evaluate the GERD patients who experience symptoms despite taking high-dose proton pump inhibitor (PPI) medications.
The company will use the results from the trial to secure approval for the device from the US Food and Drug Administration (FDA).
LESS GERD trial is a multicenter, randomized, double-blind and sham-controlled pivotal study, which will recruit around 110 patients at around 30 sites in the US and Europe.
The company has implanted the device at the Keck School of Medicine of the University of Southern California in Los Angeles.
EndoStim's LES stimulation system is a minimally-invasive and implantable device that will offer long-term reflux control by restoring normal esophageal function through neurostimulation.
The therapy is said to directly target the patient's weak or dysfunctional LES muscle between the stomach and the esophagus, which is the cause of reflux.
The trial will evaluate the effects of the EndoStim system System on GERD outcomes, including esophageal acid exposure, GERD symptoms such as heartburn and regurgitation and ability to avoid dependence on PPI medications.
EndoStim LES stimulation system secured CE mark approval to treat patients with gastroesophageal reflux disease with symptom duration of six months or longer.
The study investigator Dr Nicholas Shaheen said: "Published international data suggest that the EndoStim system can successfully control symptoms and abnormal acid exposure in the esophagus and significantly improve patients' quality of life with minimal side effects.”