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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) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Study Status Terminated
Application Number P000008 S017/ PAS002
Date Current Protocol Accepted 03/03/2016
Study Name Apollo-001
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description NOTE: The PAS requirement for the lower BMI patients is being closed prior to its completion because in clinical practice LAP-BAND is not widely used for the lower BMI patients. Continuing enrollment would not have added value. In addition, the label already reflects long-term performance for the higher BMI patients. Therefore, no labeling update is needed at this time.
New enrollment study designed to evaluate the safety and effectiveness of Lap-Band. Prospective single-arm cohort.
Study Population Description Patients with BMI >=30 kg/m2 and <40 kg/m2 and 1 or more obesity-

related comorbidities. There is no control group in this study.

Sample Size 325 subjects will be enrolled across 20 U.S. sites. Assuming 20% attrition, a sample size of 260 subjects at 5 years provides 84% power to test the hypothesis that the reduction in diabetes prevalence at 5 years will be at least 5%. This will be tested using a 1-sided exact binomial test with a 5% significance level. Up to 65 subjects can be enrolled per site.

Data Collection Primary safety endpoint: 5-year explant rate; Secondary effectiveness

endpoints: 5-year responder rate (where response is defined as achieving >=

7% TBL), diabetes prevalence at 5 years, and change in obesity-related comorbidities at 5 years compared to baseline

Follow-up Visits and Length of Follow-up 10 Years - In-office visits before and after surgery, at 1, 2, 3, and 6 months, and 1, 3, 5,

7, and 10 years after surgery. Patients will complete a questionnaire at 2, 4,

6, 8, and 9 years after surgery.

Interim or Final Data Summary
Actual Number of Patients Enrolled 175 patients received device implant, 32 with low BMI of 30.00- 34.99
Actual Number of Sites Enrolled 13
Patient Follow-up Rate 92.2% at 1 year (based on the number of subjects (77) eligible for the 1-year visit)
Final Safety Findings The 1-year rates for device explant, band slippage, and erosion are same at 3.1% for low BMI patients of 30.00-34.99. The 1-year rate is 0% for device explant, 1.4% for slippage, and 0% for erosion in patient with BMI of 34.00-39.99 The long-term safety information is available from the 5-year HERO-002 study.

Final Effect Findings Final effectiveness findings (key endpoints):

The 1-year responder rate is 73.7% for low BMI patients (30.00-34.99), and 86.2% for patients with BMI of 34.00-39.99. The long-term effectiveness information is available from the 5-year the HERO-002 study.

Study Strengths & Weaknesses Strength: Long-term data available through 5-years of follow-up from the 5-year the HERO-002 study.

Weaknesses: Slow study enrollment was observed for lower BMI patients, since in clinical practice the device is not widely used for lower BMI patients. Therefore, the study was closed prior to its completion, since enrolling more patients would not have added value.
Recommendations for Labeling Changes The label already reflects long-term performance; therefore, no additional labeling update is needed at this time.

Apollo-001 Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 08/17/2011 11/25/2011 Overdue/Received
one year report 02/16/2012 02/15/2012 On Time
18 month report 08/16/2012 08/17/2012 Overdue/Received
two year report 02/15/2013 02/13/2013 On Time
Interim Progress Report 08/14/2013 08/14/2013 On Time
three year report 02/15/2014 03/13/2014 Overdue/Received
six month report 03/24/2015 03/26/2015 Overdue/Received
one year Report 09/24/2015 10/16/2015 Overdue/Received
18 month report 03/24/2016 03/25/2016 Overdue/Received
two year report 09/24/2016 09/26/2016 Overdue/Received
30 month report 03/24/2017 03/22/2017 On Time
Final Report 05/22/2017 05/22/2017 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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