SRS Endoscopic System Receives FDA Clearance for Treatment of Gastroesophageal Reflux Disease (GERD)
OMER, Israel, May 24, 2012 /PRNewswire/ --
The SRS system by Medigus, offers endoluminal treatment for one of the most common chronic conditions
Medigus Ltd. (TASE: MDGS) announced that it has received FDA 510(k) marketing clearance for its SRS endoscopic system.
The SRS device is intended for minimally-invasive endoluminal treatment of GERD. The SRS endoscope is inserted into the esophagus through the mouth and does not entail incisions into the abdominal cavity. The endoscope contains a miniature video camera, ultrasonic sights, and a stapling device that enables the operator to perform partial fundoplication.
The device was cleared for marketing by the U.S. Food and Drug Administration in the 510(k) pathway, having successfully met safety and efficacy criteria during a multi-center clinical trial in five countries and three continents. In addition to the FDA clearance, Medigus already possesses a CE mark for the SRS system.
According to several sources, including the US Market for Gastrointestinal Endoscopic Devices 2011 & 2012, iData Research, the estimated potential market for endoscopic treatment of GERD in the United States is 33 billion US dollars, and the number of patients suffering from GERD among the global population ranges between 5%-17%.
GERD is caused by stomach acid or bile frequently flowing back into the esophagus. This irritates the esophagus, causing acid reflux, heartburn and other severe conditions.
About Medigus Ltd.
Medigus is a medical device company that specializes in developing innovative endoscopic procedures and devices. Medigus is a pioneer developer of a unique proprietary endoscopic device for the treatment of GERD. Medigus has an advanced technology platform that includes the necessary elements for developing a wide range of endoscopic procedures. The platform includes the smallest CCD and CMOS video cameras in the world, endoscopic staplers, ultrasound and endoscopy suites.
Dr. Yaron Silberman
SOURCE Medigus Ltd