NIJMEGEN, Netherlands and ST. LOUIS, Dec. 2, 2015 /PRNewswire/ — EndoStim is pleased to announce approval of its minimally-invasive therapy for gastroesophageal reflux disease (GERD) in Brazil.
EndoStim received approval from ANVISA, the Brazilian health authority, for its EndoStim II LES Stimulation System. EndoStim’s neurostimulation therapy is a long-term treatment option for patients with chronic reflux who may not be ideally treated with medication therapy. The minimally-invasive nature of the therapy is designed to preserve natural anatomy, thus avoiding most side effects sometimes associated with anti-reflux procedures.
“We believe that EndoStim will have an important impact in the treatment of GERD, a common disease in Brazil. EndoStim is unique because it truly addresses the underlying problem of reflux without significantly changing the patient’s anatomy,” commented Dr. Richard Gurski, Chief of Digestive Surgery at the Hospital de Clinicas Porto Alegre. “The published results so far are very promising; EndoStim can change the way we treat reflux, especially for patients who are unsatisfied with their medical therapy.”
“We are thrilled to collaborate with Dr. Gurski and other specialists throughout Brazil to launch our technology,” added Simone Arins, Vice President of Business Development – Latin America, at EndoStim.
More than 250 GERD patients worldwide have been successfully treated with EndoStim therapy to date.
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.