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.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
This study is desgined to extend the follow-up patients enrolled in the premarket study. Patients
will be followed for 3 years after the date of their first Radiesse study injection in the premarket study.
Study Population Description
This device is indicated for subdermal implantation for the correction of moderate to severe facial
wrinkles and folds such as nasolabial folds. Thr study population includes premarket study population.
Sample Size
100 subjects, 4 sites
Data Collection
There were no primary effectiveness endpoints defined. Patients were assessed for the late onset of
Radiesse adverse reactions experienced since their last visit. Late onset adverse reactions included nodule, granuloma, necrosis, erosion, or infection.
Followup Visits and Length of Followup
The study required 3 year follow-up. As a part of the post-market requirement, study participants
had one or two additonal visits to meet the 3 year follow-up requirement.
Final Study Results
Actual Number of Patients Enrolled
102 of the 117 patients who participated in premarket study enrolled 99 of the 102
subjects compltede 2 study visits and 3 years of follow-up
Actual Number of Sites Enrolled
4 sites
Patient Followup Rate
97%
Final Safety Findings
No adverse events were reported by the study although its purpose was to collect long-term
safety information on the use of the device and to assess the effect of multiple injections. Expected immediate post-injection site adverse events were not collected either.
Study Strengths and Weaknesses
The weakness of the study was that there was no control group. Study weaknesses inlcude
the the following: The safety assessment is confounded by the use of other dermal fillers or Botulinum Toxin. The PAS did not collect information about the exact date of Radiesse injections; only approximate date is provided. This report does not provide the volume of Radiesse injection either.
Recommendations for Labeling Changes
Update labeling to reflect the results of the PAS taking into account study limitations
