ST. LOUIS and NIJMEGEN, The Netherlands – EndoStim, Inc., a medical device company, announced new data presented on its neurostimulation therapy for gastroesophageal reflux disease (GERD) at the 2016 United European Gastroenterology (UEG) annual meeting in Vienna, Austria. The presentations included: updated results from EndoStim’s international patient registry, results of EndoStim in patients with reflux related to bariatric surgery, and the first report of EndoStim therapy in patients with failed esophageal peristalsis and in patients post lung transplant.
EndoStim has developed a revolutionary minimally-invasive device designed to provide long-term reflux control by restoring normal esophageal function through neurostimulation. The therapy 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.
- Interim results from EndoStim’s international patient registry
This study reported interim results of a prospective multi-center observational registry of lower esophageal sphincter stimulation for GERD. To date, data is available from 105 patients in 11 sites at baseline, 72 patients at 6-month follow-up, and 42 patients at 12-month follow-up. Results were presented by Prof. Joachim Labenz, MD, Chair of the Department of Internal Medicine, Diakonie Klinikum, Siegen, Germany, who commented: “It is encouraging to see that the safety and effectiveness of LES stimulation shown in international trials are replicated in a routine clinical practice setting. It is especially exciting to see significant improvement in symptoms such as regurgitation, recurrent cough, recurrent pneumonitis, and change of voice that commonly afflict patients dissatisfied with PPI.”
- EndoStim in patients with GERD related to laparoscopic sleeve gastrectomy (LSG)
Dr. Yves Borbély, MD, FACS, Head of Upper GI Surgery, University Hospital Inselspital Bern, Switzerland, presented the results of 22 patients with LSG-associated reflux disease. LSG is one of the most commonly performed bariatric procedures, but can result in de-novo GERD and may worsen pre-existing GERD. As part of an international patient registry, 17 patients received EndoStim at least 1 year after their LSG procedure and 5 patients received the EndoStim device before or during their LSG procedure. Both groups of patients reported significant reduction in GERD symptoms as well as esophageal acid exposure. Dr. Borbély commented: “The effect of EndoStim on reflux in this population addresses an important unmet clinical need. I believe LES stimulation therapy could open the door for more obese patients to be treated with LSG who are currently excluded due to pre-existing reflux and at the same time help resolve the problem for a growing number of patients who suffer from GERD post-LSG.”
- First report of EndoStim in patients with failed esophageal peristalsis
Dysmotility associated with GERD is a challenging problem in anti-reflux surgery due to increased rates of dysphagia with Nissen fundoplication and poor reflux control with partial fundoplication. Results were presented by Prof. Alejandro Nieponice, MD, PhD, Director of the Esophageal Institute, Hospital Universitario, Fundación Favaloro, Buenos Aires, Argentina. Results from 8 patients with GERD and >50% failed peristalsis, including 2 patients post-lung transplant, were presented. All patients had poor symptom control with high-dose PPI prior to receiving EndoStim. At their last follow-up post LES stimulation therapy, patients reported significantly improved symptoms, improved esophageal acid exposure and reduced PPI use. Prof. Nieponice noted, “It is impressive to see adequate symptom control, with no dysphagia, in this group of difficult patients.” Long-term data in this sub-group of GERD patients is being collected.
The Lost Reflux Patient
Additionally, an independent study of “Lost Patients” – under-treated GERD patients in community clinics in Germany, was presented at UEG Week by Prof. Joachim Labenz. The “LOPA II” study follows the original LOPA study, which showed that nearly half of GERD patients in the GP setting on daily PPI therapy for at least one year complained of heartburn or regurgitation symptoms at least 2 days per week despite their medication. The majority had not undergone definitive GERD diagnostics to identify the reason(s) for insufficient PPI effect.
- Inadequate Symptom Control on Long-Term PPI Therapy in GERD – Fact or Fiction?
The “LOPA II” study of 368 GERD patients seen in 16 general practice clinics in Germany assessed the main reasons for patients’ dissatisfaction with PPI therapy. The study included patients who were prescribed at least 1 year of PPI therapy and were at least partially dissatisfied with their therapy. The majority (84%) cited remaining symptoms as their reason for dissatisfaction. Additional complaints included concern about the long-term risk of daily medication (34%), not wanting to take medication every day (30%), and side effects from the PPI (6%). Of these dissatisfied patients, only 10% had received prior GERD diagnostics (pH-metry and/or manometry), and only 8% previously consulted a surgeon regarding their reflux.
According to Prof. Labenz, “These patients should be systematically identified and considered for further diagnostics and/or treatment modification. Following the survey, 75% of the patients reported that they plan to visit a reflux center for further diagnostics and consultation. Importantly, this study can also help create awareness to the problem of PPI refractory reflux among community physicians.”
EndoStim is a medical device company based in St. Louis, Missouri, and Nijmegen, The Netherlands, developing and commercializing a revolutionary treatment for GERD. The EndoStim system is CE Marked for patients with gastro-esophageal reflux disease with symptom duration of six months or longer, and 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.
For more information about EndoStim, visit www.endostim.com. For more information about EndoStim’s clinical trial in the United States, visit www.lessgerd.com.
For more information, please contact: