Sometimes referred to as "The Pacemaker for the Lower Oesophageal Sphincter", Endostim is a new treatment which had its first clinical trial in 2010. Although it currently carries the CE mark permitting implantation in Europe, it has not yet received FDA approval for the US market.
An electrical stimulator is placed in the abdomen with leads to the muscles of the lower oesophageal sphincter.
It uses low energy electrical impulses to strengthen a weak or improperly functioning lower oesophageal sphincter muscle to restore the natural anti-reflux barrier between the stomach and oesophagus without interfering with normal oesophageal function such as swallowing.
In January 2012, a report published in Neuorgastroenterology and Motility following initial experimentation [r-xxii], concluded: "Short-term stimulation of the LES in patients with GERD significantly increases resting LESP without affecting esophageal peristalsis or LES relaxation. Electrical stimulation of the LES may offer a novel therapy for patients with GERD."
A paper published in Surgical Endoscopy in October 2012 [r-xxiii] reported on a pilot trial: "Electrical stimulation of the lower esophageal sphincter (LES) improves LES pressure without interfering with LES relaxation. The aim of this open-label pilot trial was to evaluate the safety and efficacy of long-term LES stimulation using a permanently implanted LES stimulator in patients with gastroesophageal reflux disease (GERD)."
A report was published on PR Newswire in February 2013 of the first patient being treated in Germany. [r-xxiv]
A paper published in Endoscopy in 2013 [r-xxv] concluded: "During the long term follow-up of 12 months, LES – EST was safe and effective for the treatment of GERD. There was a significant and sustained improvement in GERD symptoms, reduction in esophageal acid exposure with elimination of daily PPI usage, and no stimulation-related adverse effects."
"Two-year results of intermittent electrical stimulation of the lower esophageal sphincter treatment of gastroesophageal reflux disease" were published in Surgery in March 2015 [r-xxvi] concluding, “LES-EST is safe and effective for treating patients with GERD over a period of 2 years. LES-EST resulted in a significant and sustained improvement in GERD symptoms, and esophageal acid exposure and eliminated PPI use in majority of patients (16 of 21). Further, LES-EST was not associated with any gastrointestinal side effects or adverse events.”
In March 2015, PR Newswire reported Endostim had released a "second generation" stimulator that was smaller in size with "improved MRI conditional compatibility for head and extremity imaging procedures, adding support for 3T MRI machines in addition to the 1.5T MRI machines." [r-xxvii]
NICE has been notified about this procedure and is developing guidance on it. [r-xxvix]