Spatz3 Adjustable Balloon System® (Spatz3) Post Approval Study

Inclusion Criteria:

1. Age 22 - 65
2. BMI ≥ 35 and <40 kg/m2 or BMI of 30 to 34.9 kg/m2 with one or more major obesity-related comorbid conditions
3. Willingness to comply with the substantial lifelong dietary restrictions required bythe procedure
4. History of obesity (BMI ≥ 30) for at least 2 years
5. History of failure with non-surgical weight loss methods
6. Willingness to follow protocol requirements, including signed informed consent,routine follow-up schedule, completing laboratory tests, completing diet counseling
7. Residing within a reasonable distance from the investigator's office and able totravel to the investigator to complete all routine follow- up visits
8. Ability to give informed consent
9. Women of childbearing potential (i.e., not post-menopausal or surgically sterilized)must agree to use adequate birth control methods. Acceptable birth control methods arelimited to hormonal contraceptives (oral, flexible vaginal ring, skin patch,injection), diaphragms, IUDs, condoms with or without spermicide, and voluntaryabstinence. Should a treatment arm subject become pregnant during the implantationperiod, the balloon will be extracted during the second trimester - the timing ofwhich will be determined via consultation with the subject's obstetrician.

Exclusion Criteria:

1. Prior surgery involving the esophagus, stomach, and duodenum or bariatric surgery.
2. Prior open or laparoscopic bariatric surgery.
3. Prior surgery of any kind on the esophagus, stomach, duodenum or any type of hiatalhernia surgery.
4. Any inflammatory disease of the gastrointestinal tract including esophagitis,Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer or specificinflammation such as Crohn's disease
5. Potential upper gastrointestinal bleeding conditions such as esophageal or gastricvarices, congenital or acquired intestinal telangiectasis, or other congenitalanomalies of the gastrointestinal tract such as atresias or stenoses.
6. A gastric mass.
7. A hiatal hernia > 2cm or severe or intractable gastro-esophageal reflux symptoms.
8. Acid reflux symptoms to any degree that require more than one medication for symptomcontrol.
9. A structural abnormality in the esophagus or pharynx such as a stricture ordiverticulum that could impede passage of the balloon alongside the endoscope.
10. Achalasia or any other severe esophageal motility disorder that may pose a safety riskduring the removal of the device
11. Severe coagulopathy.
12. Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood ofrequiring insulin treatment in the following 12 months.
13. Subjects with any serious health condition unrelated to their weight that wouldincrease the risk of endoscopy
14. Chronic abdominal pain
15. Motility disorders of the GI tract such as gross esophageal motility disorders,gastroparesis or intractable constipation
16. Hepatic insufficiency or cirrhosis
17. Serious or uncontrolled psychiatric illness or disorder that could compromise patientunderstanding of or compliance with follow up visits and removal of the device after 8months.
18. Alcoholism or drug addiction.
19. Patients unwilling to participate in an established medically-supervised diet andbehavior modification program, with routine medical follow-up.
20. Patients receiving daily prescribed treatment with aspirin, anti-inflammatory agents,anticoagulants or other gastric irritants.
21. Patients who are unable or unwilling to take prescribed proton pump inhibitormedication for the duration of the device implant.
22. Patients who are known to have, or suspected to have, an allergic reaction tomaterials contained in the system.
23. Patients who have BOTH:
24. A previous history of a serotonin syndrome AND
25. currently taking any drug known to affect the levels of serotonin in the body [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrinereuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)].
26. Patients who are pregnant or breast-feeding.
27. Subjects with Severe cardiopulmonary disease or other serious organic disease whichmight include known history of coronary artery disease, Myocardial infarction withinthe past 6 months, poorly controlled hypertension, required use of NSAIDs
28. Subjects who have tested positive for H. Pylori, and who have not yet been treated.
29. Subjects taking medications on specified hourly intervals that may be affected bychanges to gastric emptying, such as anti-seizure or anti-arrhythmic medications
30. Subjects who are taking corticosteroids, immunosuppressants, and narcotics
31. Subjects who are taking diet pills
32. Use of an intragastric device prior to this study due to the potential increase inrisk associated with implantation of a balloon in a previously instrumented andpossibly scarred stomach.
33. Participation in any clinical study which could affect weight loss within the past 6months due to the potential to confound findings.
34. Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary arterydisease.
35. Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD),pneumonia or cancer.
36. Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous,scleroderma) or immunocompromised.
37. Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medicalcondition, in the opinion of the investigator because of an increased risk profile.
38. Specific diagnosed genetic or hormonal cause for obesity such as untreatedhypothyroidism or Prader Willi syndrome
39. Eating disorders including night eating syndrome (NES), bulimia, binge eatingdisorder, or compulsive overeating
40. Known history of endocrine disorders affecting weight