BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Intragastric For Morbid Obesity

    PMA: P160001 · Supplement: S042 · Decision Aug 8, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Implant, Intragastric For Morbid Obesity
    Trade Name
    Obalon Balloon System
    PMA Number
    P160001
    Supplement Number
    S042
    Device Class
    FDA Class 3
    Product Code
    LTI
    Generic Name
    IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 8, 2019
    Date Received
    June 14, 2019
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the revised protocol for the post-approval study protocol.The Obalon Balloon System Post-Approval Study is a prospective, open-label, single-arm study of the safety and effectiveness of the Obalon 6-month Balloon System, as an adjunct to weight loss for obese adults 22 years of age and older with a Body Mass Index (BMI) of 30 kg/m2 to 40 kg/m2. This is a 12-month follow-up study in which subjects will be treated during the first 6 months with placement (via swallow) of up to three Obalon Balloons in conjunction with a moderate intensity weight loss and behavioral modification program standardized throughout the sites, followed by observational evaluation for an additional 6 months after device removal. This study will include Obalon balloons contained in animal-based capsules (approved in original PMA) and plant-based hydroxy propyl methyl cellulose (HPMC) capsules (being approved under PMA S003). A total of 200 subjects will be enrolled at 10 to 15 sites in the United States; 180 evaluable subjects will be available at 6 months, including a minimum of 50 patients receiving animal-based gelatin capsules and a minimum of 50 patients receiving plant-based HPMC capsules.The primary endpoint is to evaluate the safety of Obalon by assessing the rate of device- or procedure-related Serious Adverse Event(s) (SAEs) (composite safety endpoint). Where the SAE is defined as any AE that results in death or persistent/significant disability and/or incapacity, which may include emergency room visits, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, or requires medical/surgical intervention to prevent any of the above, through 6 months of treatment with the Obalon 6-month Balloon System. The observed rate will be compared to a performance goal of 10% at 6 months assuming an expected 4.5% device or procedure related SAEs rate. The secondary effectiveness endpoint is comprised (1) the mean % Total Body Loss (%TBL) and (2) the proportion of subjects achieving at least -5% TBL through the first 6 months after the device is implanted.Additional endpoints include observational safety and effectiveness analyses including the percentage of subjects and frequency of individual Adverse Events (AEs) that are device- or procedure-related, frequency and cause of early explantations, rates of gastric ulceration, esophageal tear, balloon deflation, means of other weight loss metrics such as % Excess Weight Loss (EWL), Weight Loss (WL) in pounds, and BMI change, percentage of subjects with at least 6%, 7%, 8%, 9%, and 10% TBL, percentage of subjects with at least 25% EWL, patient-reported outcomes assessing tolerability of device and/or quality of life, weight loss metrics by number of balloons placed, weight loss metrics by frequency of weight loss and behavioral modification program counseling. Descriptive analyses will be presented and stratified by capsule type.Follow-up assessments will be in office visits at Day 0, monthly during the first 6 months and at 12 months after initial implant. The Obalon 6-month Balloon System requires removal of all 3 balloons at the end of the 6-month period. Subjects will be followed for an additional 6 month period to ensure there are no Adverse Events as a result of balloon removal or residual events due to balloon use. Subjects with gastric ulcerations at the time of device explant will be followed with endoscopic evaluation every 8 weeks until the ulcer has visually resolved.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LTI Implant, Intragastric For Morbid Obesity