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LES stimulation therapy

EndoStim LES stimulation therapy is safe and efficacious

At six month follow-up, 93% were free of PPI dependence and patients' median oesophageal pH, measured by 24-hour pH-metry, decreased from 9.9% at baseline to 4.4%

The interim results of an international multi-centre trial show that EndoStim’s neurostimulation minimally-invasive therapy device in patients with gastro-oesophageal reflux disease (GERD) insufficiently controlled by medication, demonstrated safety and efficacy leading to significant improvements in both GERD symptoms and patients' oesophageal acid exposure, the gold-standard biomarker for GERD, through six months of therapy. The study will continue through completion of patients' two-year post-therapy follow-ups. The outcomes of 41 patients from 10 institutions worldwide were published in  the journal Alimentary Pharmacology & Therapeutics.

Implantation of EndoStim’s system is performed using standard laparoscopic techniques - after trocar placement, dissection of fat tissue is performed to expose the muscle wall of the distal oesophagus. In the presence of a small hiatal hernia, repair by caudal retraction of the oesophagus and tightening of the hiatus by standard surgical procedure is indicated.

The bifurcated lead is then introduced into the abdominal cavity and using a guiding needle, the electrodes at the proximal end of the lead are inserted and secured into the oesophageal muscle wall. Upper gastrointestinal endoscopy is performed to identify the Z-line by trans-illumination and to avoid perforation during electrode placement. The distal end of the bipolar lead is retracted through the abdominal wall and connected to the implanted pulse generators (IPG).

After a functionality test of the whole implanted system by the operator, the IPG is then placed into a subcutaneous pocket 3–5cm below the left costal margin. After the anaesthetics have worn off, the IPG is programmed for electrical stimulation therapy. Patients usually stay over in the hospital for one night for observation and are advised to wear an elastic compression bandage over the subcutaneous pocket and the IPG for 10–14 days to prevent formation of a seroma.

Prior to treatment with EndoStim, 91% of patients were taking at least daily proton pump inhibitor (PPI) medication and 58% were taking PPI at least twice daily. At their six month follow-up, 93% were free of PPI dependence. In addition, patients' median oesophageal pH, measured by 24-hour pH-metry, decreased from 9.9% at baseline to 4.4% at their six-month follow-up.

Quality of life measured by the validated GERD-Health Related Quality of Life questionnaire also significantly improved from a median score at baseline of 31.0 without PPI and 16.5 with PPI to 5.0 at six-month follow-up (score 0 = no disruption of quality of life disruption due to GERD symptoms, 45 = maximum disruption of quality of life due to GERD symptoms). Patients also reported significantly fewer days and nights with heartburn and/or regurgitation, and also reported improved overall sleep quality and less disruption of work and other activities due to GERD.

"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." commented Professor Dr Peter D Siersema, Chief of the Department of Gastroenterology and Hepatology at the University Medical Center, Utrecht, the Netherlands, and the senior author of this trial.

The study also looked at a subgroup of patients with significant hiatal defect that required a hiatal repair procedure at the same time as the EndoStim procedure. The results were encouraging; these patients responded equally well to therapy as those without a hiatal defect as long as the hiatal defect was repaired.

"This is an important finding because now we can consider EndoStim therapy in those patients with significant hiatal defects by combining EndoStim with a simple hiatal repair procedure," said Professor Dr Carsten Gutt, Chief of Surgery at Klinikum Memmingen, Germany.

Consistent with prior reports on LES stimulation, Kappelle et al. report that side effects commonly observed after anti-reflux surgery were not observed in patients treated with EndoStim, likely due to the non-disruptive nature of the EndoStim procedure and no interference of the stimulation on LES relaxation in response to swallows.

The EndoStim system is CE Marked for patients with gastro-oesophageal reflux disease with symptom duration of six months or longer. EndoStim is available in a number of countries throughout Europe, Latin America, and Asia Pacific. The EndoStim system is not approved for sale in the US and is limited by US federal law to investigational use only.

To access this paper, please click here

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