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Product approval

EndoStim's LES Stimulation System approved in Brazil

The minimally-invasive nature of the therapy is designed to preserve natural anatomy, thus avoiding most side effects sometimes associated with anti-reflux procedures

EndoStim’s minimally-invasive therapy for gastroesophageal reflux disease (GERD)  has been approved in Brazil. The company 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, Brazil. "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."

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.

"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 EndoStim.

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.

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