FSIEGastroesophageal reflux disease (GERD) is a common ailment affecting millions of patients worldwide and is an important topic of FSIE research. The spectrum of this disease varies widely depending upon patient symptoms and individual patient anatomical and pathological factors. Despite this complexity the mainstays of therapy have been limited to only antacid medications and surgical laparoscopic fundoplication (Nissen) for more than 25 years. Clinicians treating GERD have long known that these two options are very effective for a majority of patients but not nearly all. Studies show that up to 60% of patients are dissatisfied with medication alone but do not want or meet criteria for surgery. This leaves a lot of patients unhappy. This has driven innovation in the field of GERD treatment.
The Endostim technology represents one of these innovations aimed at providing another alternative for GERD therapy. The Endostim device is comprised of a small generator that is implanted under the skin. The device is connected to two lead wires that connect the stimulator to the distal esophagus. It is implanted with a minimally invasive outpatient procedure. The initial international studies demonstrate very promising results both in terms of safety and efficacy. These early data suggest that the EndoStim system can successfully improve patients’quality of life by controlling symptoms and abnormal acid exposure with minimal side effects.
FSIE Innovators have a long standing history of active participation in pivotal trials of new GERD technology including Dr Swanstrom's performance of the first laparoscopic Nissen fundoplication in the United states, Dr Dunst's long term involvement in magnetic lower esophageal sphincter augmentation (LINX Torax Medical) trials and Dr Reavis instrumental role in clinical trials for Transoral Incisionless Fundoplication (TIF Endogastric Solutions) among others. We are excited to announce that innovations team members Drs Swanstrom, Dunst, Reavis and DeMeester have joined a new important study in the treatment of GERD as part of their clinical practice with The Oregon Clinic. The LESS GERD trial is a multicenter, randomized, double-blind, sham-controlled pivotal trial designed to evaluate the safety and efficacy of the EndoStim Lower Esophageal Sphincter (LES) Stimulation System in patients with gastro-esophageal reflux disease (GERD) who experience symptoms despite taking high-dose proton pump inhibitor (PPI) medications. The results from the trial will support EndoStim’s premarket approval application to the U.S. Food and Drug Administration (FDA). Patients seeking information on the trial should visit: www.lessgerd.com or call FSIE doctors at The Oregon Clinic at 503-281-0561 (ask for Lisa or Angi).
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