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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Realize PAS

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Application Number P070009 / PAS001
Current Plan Approved 09/09/2008
Study Name OSB Lead-Realize PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, single-arm, multi-center study designed to look at the long-term re-operation rates seen with the Swedish Adjustable Gastric Band.
Study Population Description Study population: Subjects are between the ages of 18 and 60 years old who have been diagnosed with morbid obesity and considered appropriate candidates for surgical weight reduction. Indication: Patients with one or more significant medical conditions related to obesity for which the subject is being treated, and which are generally expected to be improved by weight loss. Body Mass Index (BMI) must be greater than or equal to 35 kg/m2 and less than or equal to 40 kg/m2.
Sample Size 300 patients, 8 sites
Data Collection The primary endpoint is the re-operation rate (including band revisions, band replacements, and explants) in years four and five post-implant. Secondary endpoints are: HbA1c levels, serum lipid levels, amount of excess body weight loss, quality of life measured by SF-36, Beck Depression Inventory scale score, adverse event rate, severe adverse event rate
Follow-up Visits and Length of Follow-up Subjects will be followed for five years. During year 1 following implant, evaluations take place at 1, 2, 4, 6, 8, and 10 months. Evaluations will then take place at 12 months, 24 months, 36 months, 48 months, and 60 months.
Final Study Results
Interim Safety Information There were 12 adverse events reported, including atrial fibrillation (2), band infection, cholelithiasis, enterotomy of small bowel, nausea and vomiting, port disconnection, port infection, wound infection, vertigo, liver lobe lesion, and port malfunction. There were no deaths.
Number of Patients 303
Number of Sites 8
Follow-up Rate 77%
Safety Findings The primary safety goal of this study was to determine the reoperation rate (band revision, band replacement, and explants resulting from Serious Adverse Events (SAEs)) of gastric banding at 4 and 5 years post implant. The safety success criterion for this study was an observed device-related reoperations rate significantly lower than 8% for Years 4 and 5 of the study. The observed reoperation rate in the post-approval study was 8.9% with an upper bound 95% confidence interval of 12.08%, which results in failure to reject the null hypothesis (H0: Reoperation rate ? 8%). Therefore, there is no evidence that the reoperation rate is less than 8%.

The most commonly occurring AE related to the study device was GI disorders with 1,117 events experienced by 246 (81.2%) subjects. Of all the adverse events that occurred in Years 4 and 5 of the study, the most commonly occurring AE related to the study device was GI disorders with 289 events experienced by 155 (51.2%) subjects. Overall, gastroesophageal reflux disease (14.2%), vomiting (13.5%), esophageal dilation (8.9%), dysphagia (7.9%), and gastric dilatation (6.3%). The overall explant rate was 8.9% with a 95% CI range of 6.0% to


Most Frequently Occurring Device Related Serious Adverse Events include: device migration (9.2%), catheter related complication (5.0%), cholelithiasis (4.3%), cholecystitis (2.6%), and gastric dilatation (2.3%) were the most common SAEs reported throughout the entire study.

Effect Findings As a result of the reduction in BMI, important and statistically significant reductions in the lipid profile were achieved and were reported since the first year of follow-up including reductions in LDL, triglycerides, and HbA1c values, which were maintained throughout the remainder of the study. There was a statistically significant change in BMI values between each yearly time point and the value at screening. However, there was not a statistically significant change appreciated in the total cholesterol levels. The following are detailed results at 5-years post- surgery in the ITT population:

? %EWL was 35.6 ± 26.84;

? Mean reduction in BMI (kg/m2) was -7.0 ± 5.45 (95% CI: -7.7 to -6.3);

? Mean reduction in absolute weight (lb) and mean % in weight reduction (%) was -43.1 ±

32.5 (95% CI: -47.3 to -39.0), and 16.0 ± 11.9 (95% CI: 14.5 to 17.6) respectively;

? The Physical Component score and the domain scores for SF-36 showed improvement at every post-surgery visit;

? The total transformed score and the domain scores for the IWQOL-Lite showed improvement at every post-surgery visit in the CI-07-0006 cohort;

? Mean reduction in HbA1c (%) was -0.22 ± 0.823 (95% CI: -0.33 to -0.11), which was statistically significant;

? Mean increase in HDL (mg/dL) was 9.3 ± 11.51 (95% CI: 7.7 to 10.8), which was statistically significant;

? Mean reduction in LDL (mg/dL) was -7.3 ± 31.90 (95% CI: -11.6 to -3.0), which was statistically significant;

? Mean reduction in total cholesterol (mg/dL) was -2.0 (95% CI: -7.8 to 2.0), which was not

statistically significant; and

? Mean reduction in triglycerides (mg/dL) was -28.2 ± 110.15 (95% CI: -42.7 to -13.7), which was statistically significant.

Strengths & Weaknesses Enrollment was successful: A sample size of 300 was expected and a total of 303 were studied.

A five-year follow-up was achieved providing long-term safety and effectiveness data. Weaknesses:

No concurrent comparison group, which limits interpretation of the results. Based on this one study, statements comparing the device to alternative treatments cannot be


A 77% follow-up rate was attained. Loss to follow-up limit the interpretation of the study results. The subjects that remain in the study may be different to those that were lost, and therefore, the generalizability of results can be limited.

Label Changes PAS study data must be added to the labeling including: description of the study design and methods, and the new safety information through 5 years of follow-up.

OSB Lead-Realize PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year report 09/27/2009 09/28/2009  
2 year report 09/27/2010 09/27/2010 On Time
3 year report 09/27/2011 09/26/2011 On Time
4 year report 09/26/2012 09/25/2012 On Time
5 year report 09/26/2013 09/26/2013 On Time
6 year report 09/26/2014 09/23/2014 On Time
final report 05/29/2015 05/29/2015 On Time
pages left out of final report 07/29/2015 07/29/2015 On Time

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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