ReCharge Clinical Trial

• Primary efficacy objective [ Time Frame: 12 months ] [ Designated as safety issue: No ]

  Observe a 10% greater EWL from randomization with the Maestro System after 12 months of VBLOC Therapy compared to control by BMI method.

  Observe clinically meaningful responder rates in the treatment arm of 20% and 25% EWL from implant at 12 months (not statistically based).

• Primary safety objective [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  To demonstrate a 12 month Serious Adverse Event rate related to device, implant/revision and therapy of less than 15%.

To determine the safety and efficacy of the Maestro RC2 System in producing weight loss in obese subjects.

The Maestro RC2 System is a neuromodulation system.

All subjects will be randomized in a 2:1 allocation to treatment or control group.

All subjects will be followed through the 12-month follow-up visit. Subjects in the control group who choose to have an active device will undergo a second surgery.

• Obesity
• Overweight

• Device: Active, implantable, intra abdominal vagal blocking medical device (Maestro RC2 System)
  Active device will deliver VBLOC Therapy
  Other Name: Maestro RC2 System
• Device: Active, implantable, intra abdominal vagal blocking medical device (Maestro RC2 System)
  Control device will deliver no VBLOC Therapy
  Other Name: Maestro RC2 System

• Active Comparator: Active Device
  The treatment group will receive a functional device that will deliver charge to the vagus nerve during the study period
  Intervention: Device: Active, implantable, intra abdominal vagal blocking medical device (Maestro RC2 System)
• Sham Comparator: Non-active Device
  The control group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period
  Intervention: Device: Active, implantable, intra abdominal vagal blocking medical device (Maestro RC2 System)

Inclusion Criteria:

• Informed consent.
• 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 severe obesity related co-morbid condition.
• Females or males.
• 18-65 years of age inclusive.
• Type 2 diabetes mellitus subjects that are well-controlled.
• Failure to respond to supervised diet/exercise program(s) in which the subject was engaged within the last 5 yrs.
• Ability to complete all study visits and procedures.

Exclusion Criteria:

• Concurrent chronic pancreatic disease.
• History of Crohn's disease and/or ulcerative colitis.
• History of bariatric surgery, fundoplication, gastric resection or major upper-abdominal surgery.
• History of pulmonary embolism or blood coagulation disorders.
• Clinically significant hiatal hernias known from subject's medical record as or determined by upper endoscopy prior to implant.
• Current portal hypertension and/or esophageal varices.
• Intra-operative exclusion: hiatal hernia requiring surgical repair or extensive dissection at esophagogastric junction at time of surgery.
• Treatment with weight-loss prescription drug therapy within the prior three months and the use of prescription drug therapy or the use over-the-counter weight loss preparations for the duration of the trial.
• Smoking cessation within the prior six months.
• Known genetic cause of obesity.
• Overall sustained reduction of more than 10% of body weight in the previous 12 months.
• Pre-operative diet with intent to lose weight prior to surgery.