Endostim Implantation

Abstract

Gastroesophageal reflux disease (GERD) is common and the primary treatment consists of acid suppression agents. Patients who do not respond to such agents, or are reluctant to use them, are offered a surgical therapy, typically a fundoplication. Concerns about side effects of fundoplication have led to adoption of endoscopic and alternative surgical approaches. Electrical stimulation of the lower esophageal sphincter (LES) was conceived as such an approach. Acute stimulation in animal models and in humans showed a consistent enhancement of LES pressure. Open label studies in patients with GERD showed a sustained and significant improvement in esophageal acid exposure and in GERD Health-Related Quality of Life. Good safety profile, lack of dysphagia, and the efficacy observed in these studies, led to a multicenter, sham-controlled pivotal clinical trial. However, the study failed to show a superiority of stimulation over placebo in the main efficacy endpoint, leading to its termination.