EndoStim LES Stimulation therapy demonstrates long term safety and efficacy results in treating reflux patients

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Mar 25, 2015, 09:34 ET

ST LOUIS and the HAGUE, Netherlands, March 25, 2015 /PRNewswire/ -- EndoStim announced publication of two-year results of LES Stimulation therapy for chronic gastro-esophageal reflux disease (GERD) in the March issue of the journal Surgery [Surgery. 2015; 157(3):556-567], establishing the long term safety and efficacy of its minimally-invasive therapy.

The study included 25 patients with severe GERD with an average duration of 11 years and taking prescribed daily proton pump inhibitor (PPI) medication for an average duration of 5.6 years prior to the study. The study highlights significant improvements in patients' quality of life, GERD symptoms including heartburn and regurgitation, and objectively measured esophageal acid exposure; results were consistent with previously reported outcomes in the same cohort of patients after one year of therapy [Endoscopy. 2013; 45:595-604].

Patients' median esophageal pH decreased from 10% at baseline to 4% after two years of continuous stimulation therapy. Quality of life measured by the validated GERD-Health Related Quality of Life questionnaire also significantly improved from a median score at baseline of 23.5 without PPI and 9 with PPI to 0 at two-year 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).

After two years of EndoStim therapy, 90% of patients were able to eliminate their dependence on PPI medications¹ (76% of patients were completely free of PPI use, and 14% reduced PPI use to <50% of days).

"Esophageal acid exposure, an objective and robust measure of GERD, improved significantly from baseline to two years, demonstrating a sustained long-term effectiveness of LES stimulation therapy and confirming that LES stimulation can be recommended for management of GERD in patients looking for an alternative to traditional antireflux surgery," explained Dr. Edy Soffer, Professor of Clinical Medicine in the Gastroenterology Division at the University of Southern California's Keck School of Medicine.

In an accompanying editorial, Professor Stephen Attwood, Surgeon at North Tyneside General Hospital and Honorary Professor at Durham University, comments that "the improvements are profound," and are "backed by objective testing with pH monitoring." He further remarks that "There is no other therapy for GERD with this magnitude of effect or lack of side-effects." [Surgery. 2015; 157(3):568-569]

In the study, no serious adverse events related to the procedure, device, or therapy were reported. Additionally, no patients reported gastrointestinal side effects, such as new-onset dysphagia (difficulty swallowing), bloating, inability to belch, or diarrhea, which are often reported with traditional anti-reflux procedures, further supporting the excellent safety profile of LES stimulation that was already reported at one year.

Preliminary results of an ongoing international multicenter trial in 10 sites worldwide have confirmed the positive outcomes of this trial.

About EndoStim

EndoStim is a venture-backed medical device company based in St. Louis, Missouri, and the Hague, 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.

References:

Surgery 2015; 157(3):556-567
© 2015 Elsevier Inc.

¹ Dependence on PPI medications defined as requiring PPI >50% of daily diary days to control GERD symptoms

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SOURCE EndoStim