Medical device firm EndoStim has presented the interim results of an international multicenter trial, which showed safety and efficacy of its minimally-invasive therapy in patients with gastroesophageal reflux disease (GERD) insufficiently controlled by medication.
EndoStim’s neurostimulation therapy is a minimally-invasive and long-term treatment for severe reflux patients, which directly targets the patient’s weak or dysfunctional lower esophageal sphincter (LES) muscle between the stomach and the esophagus.
According to the firm, the study results of 41 patients from 10 institutions across the globe demonstrated that EndoStim therapy led to significant improvements in both GERD symptoms and patients’ esophageal acid exposure.
The company will continue the trial through completion of patients’ two-year post-therapy follow-ups.
Senior author of the trial and Dr Peter Siersema said: "Our results show uniformity in outcome across multiple centers as well as consistency with the results reported in a single center study with published results up to two years of follow-up."
The trial also examined a subgroup of patients with significant hiatal defect that required a hiatal repair procedure at the same time as the EndoStim procedure. These patients also reacted equally well to therapy as those without a hiatal defect as long as the hiatal defect was repaired.
The EndoStim system received CE mark approval to treat patients with GERD with symptom duration of six months or longer.
EndoStim is commercially available in multiple countries across the Europe, Latin America, and Asia Pacific. It is not approved for sale in the US and is limited by US federal law to investigational use only.