ReShape Vest™ for the Treatment of Obesity (Europe)

Inclusion Criteria:

• Obesity class II and III (Body mass index (BMI) ≥ 35 kg/m2 to ≤55 kg/m2);

• Failed one or more conservative weight-reduction alternative(s), such as superviseddiet, exercise, and behavior modification program(s) within the last five years;

• Able to comprehend, follow and give signed informed consent;

• Reside within a reasonable distance from the Investigator's treating office and ableand willing to travel to the Investigator's office to complete all routine follow-upvisits;

• Ability to comply with all study requirements for the duration of the study, asoutlined in the protocol, willing to submit to significant lifestyle changes thatinclude diet, eating and exercise habits for the duration of the clinical study;

• Females of childbearing potential (FOCBP) must be willing to avoid pregnancythroughout the duration of the study, including follow-up, and must agree to thefollowing:

• have a negative serum pregnancy test as screening,

• negative urine pregnancy test day of implant,

• and inform the investigator immediately if the subject becomes pregnant;

• Willing to abstain from illegal drugs, including marijuana and tobacco (all forms)during study participation;

• Willing to limit alcohol consumption following the opinion of the Science Group of theEuropean Alcohol and Health Forum of the European Commission;

• Has as stable concomitant medication regimen at the time of screening to mitigate druginduced weight fluctuations. A stable regimen is defined as 90 days without theintroduction of or change in medication;

• Agrees to refrain from any type of reconstructive surgery/procedures that would affectbody weight (such as abdominal lipoplasty or liposuction, mammoplasty, removal ofexcess skin or cool sculpting) during the follow-up period after the placement of theLGV.

Exclusion Criteria:

• Genetically-caused obesity, such as Prader-Willi syndrome; or any disease state knowto affect weight status such as Cushing's syndrome, untreated sleep apnea,inadequately treated thyroid disease;

• History of chronic and/or ongoing clinically significant conditions or disorders ofthe gastrointestinal (GI) tract, i.e. Gastroparesis and Inflammatory Bowel Diseasessuch as Ulcerative Colitis and Crohn's disease;

• Any abnormal stenosis or obstruction of the GI tract;

• Significant acute and/or chronic active infection including H. pylori and urinarytract infection;

• History, or signs and/or symptoms of acid-peptic disease (APD) or gastric or duodenalulcer;

• Diagnosis of portal hypertension, cirrhosis and esophageal varices;

• Presence of renal or liver disease defined as estimated Glomerular Filtration Rate (eGFR) < 45 ml/min/1.73 m2, ALT or AST > 2x upper limit normal (ULN) or totalbilirubin >1.5x ULN;

• Previous stomach or bowel surgery;

• Previous bariatric procedure or device including, but not limited to, intragastricballoons within the past twelve months, sleeve gastrectomy, endoluminal suturing andrestrictive bands;

• History of adhesive peritonitis;

• Presence of a hiatal hernia greater than 3 cm;

• History of bleeding disorders such as hemophilia;

• Unable to tolerate abstinence from blood thinners, such as warfarin, during theperi-operative period;

• Anemia defined as either: Hemoglobin (Hb) value for females of <11.0 g/dl, for males <12.0 g/dl;

• Abnormal blood cell indices deemed to be clinically significant;

• Diabetes requiring insulin at baseline (Type 1 or uncontrolled Type 2 defined as anHbA1c >12%) or a significant likelihood of requiring insulin treatment in thefollowing 24 months;

• History or known allergies to silicone or similar materials;

• Participation in other investigational study protocols. If a subject has recentlycompleted participation in another drug or device study, the subject must have exitedthat study at least 90 days prior to being enrolled in this study. If a subject screenfailed prior to receiving study intervention the subject may participate in the study;

• Concomitant use of (or within 90 days of screening), or unwillingness to avoid any useof, weight loss medications, weight loss supplements, weight loss herbal preparationsand/or participation in any non-study-related organized weight loss program (commercial or medical) at any time during the study;

• Undergoing chronic steroid or immunosuppressive therapy, defined as use of any oraland/or injectable steroid of any dose within 90 days of screening;

• Smoking cessation within two years of study entry;

• Major abdominal surgery (other than appendectomy, cholecystectomy);

• Significant traumatic injury to the abdomen within 90 days prior to enrollment;

• Subjects or immediate family members (e.g., biological parents, children,grandparents) with a known diagnosis or pre-existing symptoms of autoimmune connectivetissue disease such as systemic lupus erythematosus or scleroderma;

• Current use of medications known to cause metabolic disturbances, such as theantipsychotic agents olanzapine, quetiapine, and type 2 diabetes medicationthiazolidinedione (TZD);

• Chronic use of Non Steroid Anti-Inflammatory Drugs (NSAID) which is defined as dailyuse for greater than one month (daily low dose aspirin is acceptable);

• History or presence of malignancy such as cancer within the last five years with theexception of successfully treated non-melanoma skin cancer;

• Any condition that, in the opinion of the Investigator, would compromise thewell-being of the subject or the study or prevent the subject from meeting orperforming study requirements.