ORBERA™ Post-Approval Study

FDA post-approval study designed to demonstrate the safety and effectiveness of ORBERA™ as an
adjunct to weight reduction for obese adults (22 years of age and older) with a Body Mass
Index (BMI) of ≥ 30 kg/m2 and BMI ≤ 40 kg/m2. Behavioral modification program in conjunction
with endoscopic placement of a single ORBERA™ Intragastric Balloon, filled with saline to an
inflation volume between 400cc and 700cc, for 26 weeks followed by endoscopic ORBERA™
removal. Outcomes include the mean percent Total Body Weight Loss (%TBWL), changes in weight,
device and procedure-related AEs and SAEs: gastric ulcers, esophageal injury, placement and
removal related SAEs, early device removals, and balloon deflations.

Inclusion Criteria:

1. 22 years of age and older;

2. BMI ≥ 30 kg/m2 and ≤ 40 kg/m2;

3. Have a history of obesity (BMI ≥ 30 kg/m2) for ≥ 2 years;

4. Have failed more conservative weight-reduction alternatives, such as supervised diet,
exercise, and behavioral modification programs;

5. Be willing to commit to a long-term supervised diet and behavior modification program
designed to increase the possibility of long-term weight loss maintenance;

6. Be able to follow the requirements outlined in the protocol, including complying with
the visit schedule;

7. Be able to provide written informed consent;

Exclusion Criteria:

1. Presence of more than one intragastric balloon at the same time;

2. Prior gastrointestinal surgery;

3. Has any inflammatory disease of the gastrointestinal (GI) tract including esophagitis,
gastric ulceration, duodenal ulceration, cancer or specific inflammation such as
Crohn's disease;

4. Has any gastrointestinal bleeding conditions such as esophageal or gastric varices,
congenital or acquired intestinal telangiectasis, or other congenital anomalies of the
GI tract such as atresias or stenosis;

5. Has a large hiatal hernia or hernia > 5 cm hernia or ≤ 5 cm associated with severe or
intractable gastro-esophageal reflux symptoms;

6. Has a structural abnormality in the esophagus or pharynx such as a stricture or
diverticulum that could impede passage of the delivery catheter and/or an endoscope;

7. Has achalasia or any other severe motility disorder that may pose a safety risk during
removal of the device;

8. Has a gastric mass;

9. Has a severe coagulopathy;

10. Has hepatic insufficiency or cirrhosis;

11. Has any other medical condition which would not permit elective endoscopy, such as
poor general health or history and/or symptoms of severe renal, hepatic, cardiac,
and/or pulmonary disease;

12. Has serious or uncontrolled psychiatric illness or disorder that could compromise
subject understanding of or compliance with follow-up visits and removal of the device
after 6 months;

13. Alcoholism or drug addiction;

14. Unable or unwilling to take prescribed proton pump inhibitor medication for the
duration of device placement;

15. Unwilling to participate in an established medically-supervised diet and behavior
modification program, with routine medical follow-up;

16. Taking a daily dose of aspirin, anti-inflammatory agents, anticoagulants or other
gastric irritants routinely and not under medical supervision;

17. Females who are pregnant, nursing, or planning a pregnancy within the next year;

18. Known to have, or suspected, allergy to materials contained in ORBERA™;

19. Participation in previous (within 60 days of study day 1) or ongoing clinical trial or
current or past usage (within 60 days of study day 1) of investigational drug or
device, or any use of an intragastric balloon prior to this study;

20. Genetically caused obesity;

21. Prior bariatric surgery or considering bariatric surgery during the study ;

22. Concomitant use of, or unwillingness to avoid any use of, weight loss medications,
weight loss supplements, or weight loss herbal preparations;

23. Has a condition or is in a situation which in the Investigator's opinion may put the
subject at significant risk or may interfere significantly with the subject's
participation in the study.