The ReNEW Study: Maestro® New Enrollment Post-Approval Study Protocol

The study evaluates the safety and efficacy of the vBloc Therapy delivered by the Maestro
Rechargeable System for the treatment obesity. The Maestro Rechargeable System delivers
intermittent, electrical blocking signals to the anterior and posterior trunks of the
intra-abdominal vagus nerve (termed vBloc Therapy) and is designed to reduce sensations of
hunger and produce satiety leading to weight loss.

Subjects in the observational arm (100 subjects total) will receive the device implant and
use the vBloc Achieve Weight Management Program.

The randomized sub-study (100 subjects) will randomly assign subjects (1:1) to either
treatment (50 subjects) or control (50 subjects). The treatment arm will receive the device
implant and use of the vBloc Achieve Weight Management Program. The control arm will
participate in the Control Weight Management (CWM) during a 6 month period prior to receiving
the device implant and using the vBloc Achieve program.

The vBloc Achieve Weight Management Program consists of recommendations regarding diet,
exercise and behavior modification, and will be utilized by all subjects following their
device implant.

Inclusion Criteria:

1. Signed informed consent

2. Body mass index (BMI) ≥ 40 kg/m2 to 45 kg/m2 or BMI ≥ 35 kg/m2 to 39.9 kg/m2 with one
or more obesity related co-morbid conditions

3. Females or males. Note: females of child-bearing potential must have a negative urine
pregnancy test at Screen and also within 14 days of implant procedure followed by
physician-approved contraceptive regimen for the duration of the study period.

4. At least 18 years of age

5. Failure to respond to supervised diet/exercise program(s) in which the subject was
engaged within the last five years

6. Ability to complete all study visits and procedures

Exclusion Criteria:

1. Patients with cirrhosis of the liver, portal hypertension, or esophageal varices.

2. Patients with a large (>5cm) symptomatic hiatal hernia

3. Patients for whom magnetic resonance imaging (MRI) is planned

4. Patients at high risk for surgical complications

5. Patients who have a permanently implanted, electrical-powered medical device or
gastrointestinal device or prosthesis (e.g. pacemakers, implanted defibrillators,
neurostimulators)

6. Patients for whom shortwave, microwave, or therapeutic ultrasound diathermy is planned
Note: Diathermy is any treatment that uses high-frequency electromagnetic radiation,
electric currents, or ultrasonic waves to produce heat in body tissues. Patients
absolutely CANNOT be treated with any type of shortwave, microwave, or therapeutic
ultrasound diathermy device whether or not it is used to produce heat. These
treatments should not be applied anywhere on the body.

7. Current medical condition that, in the opinion of the investigator, would make the
subject unfit for surgery or that would be exacerbated by intentional weight loss.
Some examples include diagnosis of cancer, recent heart attack, recent stroke or
serious trauma.

8. Recent cessation of cigarette smoking (prior 2 months)

9. History of bariatric surgery, Nissen fundoplication, gastric resection, major
upper-abdominal surgery, or other abdominal procedures at the discretion of the
investigator (acceptable surgeries include cholecystectomy or hysterectomy)

10. Patients with recent (<2 years) or current history of illicit drug abuse

11. Patients with significant psychiatric disease including borderline personality
disorder, psychosis, schizophrenia, unstable depression, suicidal ideation, or mental
retardation