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 B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
This is a multi-center, non-randomized, non-controlled post-approval study.
Study Population Description
Subjects who agree to participate and are consecutively treated with Artefill in nasolabial folds (NLF).
All subjects must have a negative Artefill skin
test prior to treatment.
The sample size is 1,000 subjects who agree to participate and are consecutively treated with
ArteFill in nasolabial folds. There are to be 25 investigational sites.
Endpoints include the incidence of granuloma, incidence of serious unanticipated adverse events (including their severity
and relation to the implant product), incidence of anticipated adverse events at each follow-up, and subject's assessment of satisfaction characterized by using a five point non-parametric scale at each follow-up.
Followup Visits and Length of Followup
Patients will be evaluated at baseline before treatment is administered. Follow-up starts at the
completion of treatments. The first follow-up visit is at a 3 months after the last treatment, and then using a mail patient questionnaire the sponsor will assess adverse events and subject's satisfaction with treatment at the following intervals from the last treatment:
6, 12, and 18 months, and then 2, 3, 4 and 5 years. at the end of 5 years of follow-up, a final office visit is conducted. During the follow-up period, if a subject indicates the presence of a potential adverse event of a
questionnaire, the sponsor or its representative will contact the investigator caring for that subject. For serious adverse events related to the treatment, the investigator will contact the subject to schedule an appointment to have the event evaluated clinically at the site in a timely manner.
Final Study Results
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled
Patient Followup Rate
87% at 5 years
Final Safety Findings
Granulomas were encountered in 17 of 1,008 subjects (1.69%). A total of 887 adverse events
noted among 416 (41.3%) treated subjects. There were 177 AEs among 118 (11.7%) treated subjects that were considered device쳌]related. In general, the majority of these events were typical of dermal fillers, mild in severity and resolved during the study period. A total of 101 serious adverse events (SAEs) were noted among 75 (7.4%) treated subjects. In addition to the 7 deaths, there were 94 other SAEs.
The 94 other serious adverse events included one event of difficulty breathing, shortness of breath, or
tightness in the chest, four events of severe illness or trauma, 43 other local complications, and 46 other systemic complications. None of these SAEs were determined to be device쳌]related.
Final Effectiveness Findings
Subject satisfaction remained high throughout the study. The majority (>83%) of subjects were very satisfied
or satisfied (scored 1 or 2 on the 5쳌]point scale) with their treatment outcome at the 5쳌]year follow쳌]up.
Study Strengths and Weaknesses
This is a prospective, multicenter study that provides long term data up to 5 years
on the safety and effectiveness of the device. The follow쳌]up rate at 5 years was relatively high (87%). The weakness of the study was the lack of a comparison group.
Recommendations for Labeling Changes
The labeling will be updated based on the 5쳌]year safety and effectiveness results reported in