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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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Long Term (Nasolabial Folds)


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General
Application Number P050052 / PAS001
Current Plan Approved 12/22/2006
Study Name Long Term (Nasolabial Folds)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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.
Follow-up Visits and Length of Follow-up 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
Interim Safety Information Study completed, see final results.
Number of Patients 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
Number of Sites 4 sites
Follow-up Rate 97%
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.
Strengths & 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.
Label Changes Update labeling to reflect the results of the PAS taking into account study limitations


Long Term (Nasolabial Folds) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report long term study 12/22/2007 01/14/2008 Overdue/Received
2 year report long term 12/21/2008 04/01/2008 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
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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