ST. LOUIS and NIJMEGEN, the Netherlands, July 17, 2015 /PRNewswire/ -- EndoStim announced publication of interim results of an international multicenter trial demonstrating safety and efficacy of its minimally-invasive therapy in patients with GERD insufficiently controlled by medication [ePub ahead of print. Alimentary Pharmacology & Therapeutics. doi:10.111/apt.13306].
Study results of 41 patients from 10 institutions worldwide show that EndoStim therapy led to significant improvements in both GERD symptoms and patients' esophageal acid exposure, the gold-standard biomarker for GERD, through 6 months of therapy. The study will continue through completion of patients' two-year post-therapy follow-ups.
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 6 month follow-up, 93% were free of PPI dependence.1
Patients' median esophageal pH, measured by 24-hour pH-metry, decreased from 9.9% at baseline to 4.4% at their 6-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 6-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 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. [Surgery. 2015; 157(3):556-567]" 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," commented 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 nondisruptive nature of the EndoStim procedure and no interference of the stimulation on LES relaxation in response to swallows.
EndoStim is a venture-backed medical device company based in St. Louis, Missouri, and Nijmegen, the Netherlands.
EndoStim's neurostimulation therapy is a minimally-invasive, long-term treatment for severe reflux patients that directly targets the patient's weak or dysfunctional lower esophageal sphincter (LES) muscle between the stomach and the esophagus – often the underlying cause of reflux.
The EndoStim system is CE Marked for patients with gastro-esophageal reflux disease with symptom duration of 6 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.
About Reflux Disease
Gastroesophageal reflux disease is a chronic disease that affects hundreds of millions of patients worldwide, and often requires lifelong treatment with acid blocker medications. Symptoms generally occur when weakness or dysfunction in the lower esophageal sphincter muscle allows stomach contents to flow backward into the esophagus causing esophageal inflammation and damage. Acid reflux causes heartburn, regurgitation and can lead to Barrett's esophagus and esophageal cancer. Millions of patients continue to suffer from bothersome GERD symptoms despite maximal medical therapy.
For more information and news about EndoStim, please visit www.endostim.com.
Surgery 2015; 157(3):556-567
© 2015 Elsevier Inc.
Alimentary Pharmacology & Therapeutics 2015; doi:10.111/apt.13306
© 2015 John Wiley & Sons Ltd
1 PPI dependence defined as requiring PPI >50% of daily diary days to control GERD symptoms