Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Obalon Balloon System
• Generic Name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Applicant: ReShape Lifesciences, Inc.; 1001 Calle Amanecer; San Clemente, CA 92673
• PMA Number: P160001
• Supplement Number: S042
• Date Received: 06/14/2019
• Decision Date: 08/08/2019
• Product Code: LTI
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No

Approval Order 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.