Medigus Gets FDA Exemption for GERD Device

medigus1.jpgMedigus is an Israel-based publicly traded (TASE) medical device company founded in 2000 that specializes in developing innovative endoscopic procedures and devices for carrying out these procedures. According to Globes, it has obtained an Investigational Device Exemption (IDE) certificate from the FDA for its SRS endoscope for the diagnosis of Gastroesophageal Reflux Disease (GERD).

GERD is a very common and serious condition that can lead to more serious problems. Its main symptom is heartburn which occurs when acid in the stomach backs up into the esophagus. When this occurs two to three times per week for three months, the condition is known as GERD, or acid reflux disease. Essentially, a valve separating the esophagus and stomach (known as the lower esophageal sphincter) does not close properly, allowing acid to back up into the esophagus. Studies estimate that approximately 19 million people in the United States may have GERD.

There are a various preliminary treatments for GERD such as a change in diet, positional therapy and certain drugs (such as antacids). The standard surgical treatment is fundoplication, a procedure which staples the esophagus around the stomach thereby reducing the reflux of acid. The Medigus device improves on this procedure with a non-invasive procedure carried out by an endoscope inserted through the patient’s throat. See here for more detail on the technology.

Medigus claims the SRS endoscope has achieved the best ever results for edoluminal treatment of GERD. The FDA exemption permits the company to perform a multi-center trial similar to a Phase III trial, which if successfully completed would allow the company to immediately begin marketing the device in the U.S. The device’s 510K status means the trial can takes less time than would a Phase III trial for a regular drug.

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