Gastric Electrical Stimulation (GES) for the Treatment of Obesity

Inclusion Criteria:

- Adults ages 21-64 with BMI of 40-45 kg/m^2 or BMI 35-39.9 kg/m^2 with at least one
obesity-related comorbidity, who have failed prior non-surgical weight loss attempts,
and have been within 5% of their current weight for at least one year.

- If diabetic, subject has non-insulin-dependent type 2 diabetes mellitus diagnosed
within the last 7 years, and has an HbA1c level less than 8%.

- If female and of child-bearing age, subject is not pregnant or lactating and is
willing to use effective contraception for the duration of the study.

- Subject is willing and able to complete scheduled study visits, complete on-line
lifestyle educational modules, and complete required procedures.

Exclusion Criteria:

- Subject has a history of medical, surgical, or psychiatric conditions that, in the
opinion of the Investigators, would limit study participation or contraindicate
implantation of the Exilis GES system. Examples includes cardiac abnormalities
contraindicating surgical anesthesia, prior gastrointestinal surgery, gastrointestinal
motility disorders, inflammatory bowel disease, a history of eating disorders,
anticipated future need for magnetic resonance imaging, or allergies to food
ingredients in study test meals.