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 is an enhanced surveillance system to collect the patietns demographic, clinical and device information
for all complaints and adverse events (both MDR and non-MDR) possibly related to the Pro-Disc device up to 5 years after device approval
Study Population Description
Study population is as per device approval. The study includes all patients who received Prodisc
after device approval. This device is indicated for skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD). Symptomatic cervical disc disease is defined as neck or arm (radicular) pain and/or a ftmctional/neurological deficit with at least one of the following conditions confirmed by imaging (CT, MRI, or X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or loss of disc height. The ProDiscTM-C Total Disc Replacement is implanted via an open anterior approach. Patients receiving the ProDiscTM-C Total Disc Replacement should have failed at least six weeks of non-operative treatment prior to implantation of the ProDiscTM-C Total Disc Replacement.
Sample Size
n/a
Data Collection
Complaints and Adverse events
Followup Visits and Length of Followup
up to 5-year after device approval
Final Study Results
Actual Number of Patients Enrolled
Not applicable this is Enhanced surveillance investigation
Actual Number of Sites Enrolled
Not applicable this is Enhanced surveillance investigation
Patient Followup Rate
Not applicable this is Enhanced surveillance investigation
Final Safety Findings
Since the PMA approval of December 17, 2007 through November 1, 2012,
theinformation on the cumulative
total MDRs (n=214) and device sales has been collected and evaluated. During 60-monthds of the study period, no
unanticipated adverse events were identified, and the device has not been withdrawn from any of the markets.
Final Effectiveness Findings
Not applicable this is Enhanced surveillance investigation
Study Strengths and Weaknesses
The duration of the Enhanced Surveillance System was 5 years after PMA approval, allowing time
to monitor longer term adverse events and complaints received by the company for the device in the post-market setting.
There may be under-reporting of adverse events and complaints to the company. Therefore, the true number of adverse events and complaints during the 5-year study period is unknown.
In addition, the total number of implants sold may be an overestimate of the number of devices actually implanted.
Recommendations for Labeling Changes
No labeling change is recommended because the adverse events noted in the final report are
