In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
Multiple-center, non-randomized, cohort study
Study Population Description
Patients enrolled in the study LBMI-001:
Obesity (BMI ¡Ý 30 kg/m2 and < 35 kg/m2 with
or without comorbid conditions and BMI ¡Ý 35 kg/m2 and < 40 kg/m2 without any severe comorbid conditions) at time of LBMI-001 enrollment
Up to 149 patients
Effectiveness: The percent of subjects treated with the LAP-BAND® who achieve successful weight loss, at
5 years post- implantation, will be statistically non-inferior to 60%, where successful weight loss is defined as at least 30% Excess Weight Loss (EWL).
Safety: The primary measure is the percentage of those subjects who are explanted within 5 years postimplantation. Additionally safety measurements will include the incidence of adverse events, by severity and relation to device, observed over the study assessment period.
Followup Visits and Length of Followup
5 years post implantation
Final Study Results
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled
Patient Followup Rate
Final Safety Findings
The 5-year explant rate (including explants with replacement) was 14.8%. Therefore, the primary safety endpoint
that the 5-year explant rate is significantly lower than 32.5% has been met.
Final Effectiveness Findings
76.9% of subjects attained successful weight loss (defined as ¡Ý 30% excess weight loss) at
5 years. Therefore, the main effectiveness endpoint that 5-year successful weight loss will be noted in at least 60% of patients has been met.
Study Strengths and Weaknesses
Strengths of this study include a multi-center, prospective design of adequate sample size for long-term
(5-year) evaluation of the primary safety and effectiveness endpoints. The main limitation is the limited generalizability of results, since this post-approval study is an extended follow-up of the premarket cohort. Given that this study is likely comprised of the best responders from the pivotal trial, the main study findings may be an over-estimate of the true device performance in the lower BMI indication.
Recommendations for Labeling Changes
Labeling changes are recommended based on the long-term safety and effectiveness results of the post-approval