Medigus Ltd., a medical device company specializing in developing innovative endoscopic procedures and apparatus, has received US FDA clearance 510 (k) for marketing SRS endoscopic system. The SRS unit is intended for minimally invasive endovascular treatment of gastroesophageal reflux disease (GERD).

The SRS endoscope is inserted through the mouth into the oesophagus and involves incisions in the abdominal cavity. The endoscope includes a video camera miniaturized ultrasonic views and a clipping device which allows the operator to perform partial fundoplication.

The device was cleared for marketing by the US Food and Drug Administration (Agency for the Control of Food and Drug Administration) by the method of regulation 510 (k), having successfully met the criteria for safety and efficacy in a multi-centre clinical trial conducted in five countries and three continents. In addition to the release by the FDA, CE has already Medigus for SRS.

According to several sources, including the report US Market for Gastrointestinal Endoscopic Devices 2011 & 2012 (US Market for Gastrointestinal Endoscopic Devices 2011 & 2012), iData Research, estimated the potential market for the endoscopic treatment of GERD in the United States is of $33 billion and the number of patients who suffer from GERD among the global population varies from 5 per cent to 17 per cent.

GERD is often caused by the return of stomach acid or bile into the oesophagus. This irritates the oesophagus, causing acid reflux, heartburn and other serious conditions.

The Medigus is the pioneer developer of a unique and proprietary endoscopic device for the treatment of GERD. The Medigus has an advanced technology platform that includes the necessary elements for developing a wide range of endoscopic procedures.