Medigus Ultrasonic Surgical Endostapler (MUSE) Registry

The registry evaluates the MUSE System which creates a transoral anterior fundoplication for
the treatment of GERD. The system enables the operator to staple the fundus of the stomach
to the esophagus approximately 3cm superior to the Z-line in 2 or more locations. The
procedure is performed transorally under general anesthesia. The procedural result is
anatomically and functionally similar to standard anterior fundoplication (Dor-Thal
operation). The staples are standard, 4.8mm titanium surgical staples. Each application of
the device fires a quintuplet of staples (5) in three staggered rows. Anti-retching
medications at the time of the procedure are essential.

The study population will be primarily adults aged 18-70 years selected by the investigators
based on SAGES guidelines for fundoplication and consideration of the indications and
contraindications listed in the device Instructions for Use (IFU).

Follow-up data will be collected at 6 months, 1, 2 and 3 years post procedure.

Inclusion Criteria:

Generally follow the guidelines for Laparoscopic Fundoplication published by SAGES
(Society of American Gastrointestinal and Endoscopic Surgeons) Objective evidence of GERD

- Positive acid exposure test or endoscopic evidence of esophagitis AND

- Inadequate symptom control or

- Patient preference from surgery over medications or

- Extra-esophageal manifestations (asthma, hoarseness, cough, chest pain, aspiration)

Exclusion Criteria:

- Significant co-morbidity (for example, American Society of Anesthesiologists Grade 3
or higher)

- BMI >35 or <20

- No response to proton pump inhibitors

- Grade IV esophagitis

- Hiatal hernia >3 cm

- Irreducible hernia of any size

- Gastric outlet obstruction

- Short esophagus

- Esophageal diverticula, strictures or varices

- Esophageal motility disorders