SRS Endoscopic System for Gastroesophageal Reflux Disease Receives FDA Clearance

SRS Endoscopic System for Gastroesophageal Reflux Disease Receives FDA Clearance

The SRS system by Medigus, offers endoluminal treatment for one of the most common chronic conditions

PR Newswire – Omer, Israel, May 24, 2012 – 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.

SRS Overview

Medigus has designed and created an entire endoscopic system for intra-luminal treatment of Gastroesophageal Reflux Disease (GERD).

Medigus’ SRS™ innovative endoscopy system for the treatment of GERD performs an anterior fundoplication in lieu of the current sugical procedure, but without opening the abdominal cavity. The SRS™ endoscopy system is CE marked and FDA cleared.

The SRS endoscope combines a surgical stapler, ultrasonic sights for accurate positioning and a miniaturized video camera in a single instrument – all of which are Medigus’ proprietary technologies.

The SRS endoscope contains all of the requisite tools to complete the entire procedure while it is controlled by the physician from the outside of the patient’s body with a unique, dedicated handle and control systems.

Globes [online] is reporting that Medigus Ltd., an Israeli company, which developed an endoscopy system for the treatment of gastroesophageal reflux disease (GERD), has filed for an IPO on the Tel Aviv Stock Exchange.

We, of course, have decided to follow up to find out how the system works. According to the manufacturer, the system’s crux is in the tip and the stapling cartridge:

The distal tip includes all the elements of a standard gastroscope and in addition includes the ultrasound measurement device, the anvil of the stapler and specialized screws for anchoring the scope while the procedure is performed. All this is included in a distal tip measuring only 15mm in diameter.

To perform the procedure:

1. The SRS endoscope is introduced into the stomach much like a standard gastroscope.

2. The operator selects a stapling site in the esophagus, 2.3 – 3.0 cm above the GE junction.

3. The operator inputs the distance from the incisors.

4. The endoscope is advanced into the stomach, and retroflexed to 180°.

5. It is then pulled back so that the cartridge is at the selected stapling site.

6. The endoscope is further flexed to 270°, until the tip is aligned with the cartridge.

7. The ultrasonic sight verifies that alignment is perfect and that the distance between the anvil and the tip is small enough.

8. The operator then cranks a flywheel which extrudes two tiny screws, which penetrate distal tip SRS System: Endoscopic Partial Anterior Fundoplicationthe tissue, and lock the anvil and cartridge together.

9. The staples are then fired, the screws are withdrawn, and the scope is extended, and withdrawn.

10. The SRS is reloaded with a new cartridge, and the procedure is repeated.

11. The final result is an antero-lateral wrap, which tapers from 120 to 180 degrees, and augments the angle of His.

Source : http://www.medigus.com/NEWS/2012/FDA/News.aspx

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