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The SRS Endoscopic Stapling System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach in order to create anterior partial fundoplication for treatment of symptomatic chronic Gastro Esophageal Reflux Disease in patients who require and respond to pharmacological therapy.

The Medigus SRS is an Endoscopic Surgical Stapling System. The system enables the operator to staple the fundus of the stomach to the esophagus, in 2 or more locations around the esophageal circumference, entirely through the mouth, without any incisions. The system consists of three main parts: the endoscopic stapler, the control console and several accessories. The endoscopic stapler is a single use, sterile device which resembles an endoscope in appearance and material construction. The distal tip of the device contains a video camera, ultrasonic range finding sight, illumination, irrigation port, insufflation port, and the staple anvil. The distal tip is retroflexed to align with the staple cartridge located in the stapler. An alignment pin in the distal tip is used for initial positioning of the anvil against the cartridge. The cartridge is provided sterile and contains standard, 4.8 mm titanium surgical staples. Each application of the device fires five staples in 3 staggered rows. A new cartridge is loaded for each application. The control console includes the insufflation, light and camera electronics. The associated accessories include: - . Irrigation bottle with liquids for irrigation of the camera lens - Silicon tubes for connecting the console and other accessories to the stapler . - . Standard overtube for protecting patient's pharynx - Tweezers to remove and replace staple cartridge . - . Staple cartridges Differences between the predicate device and subject device are summarized as follows: - The subject device has a single console whereas the predicate had two consoles. - The subject device has an improved user interface and software controls . compared to the predicate. - . The subject device uses an electric motor to power staple ejection, whereas the predicate device manually ejected staples. - . The subject device contains an alignment pin mechanism to allow accurate alignment of the stapling anvil and cartridge. - The subject devices uses an LED for illumination, whereas the predicate . contained a Xenon lamp. - . The subject device contains a CMOS camera, whereas the predicate contained a CCD camera.

The SRS Endoscopic Stapling System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach in order to create anterior partial fundoplication for treatment of symptomatic chronic Gastro Esophageal Reflux Disease (GERD) in patients who require and respond to pharmacological therapy.

The Medigus SRS is an Endoscopic Stapling System. The device consists of the following components and accessories: - . The flexible endoscope combines a video camera, ultrasound sensor (range finder) and a stapler mechanism. The distal end of the endoscope is capable of retroflexion. The system enables creation of an endoluminally anterior partial fundoplication by stapling together the soft tissue of the fundus (upper part of the stomach) and the esophagus. - The endoscopy suite includes the ISL (Insufflation, Suction and Light) console and the CCU . (Camera Control Unit) console. - The associated accessories include: . - Irrigation bottle with liquids for irrigation of the camera lens l - Suction canister for extracting liquids during the procedure . - . Silicon tubes for connecting the ISL and other accessories to the endoscope - . Disposable air filter of the suction ISL input channel - I Overtube for protecting patient's pharynx