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 PRESTIGE device up to 5 years after device approval
Study Population Description
Study includes all patients who received Prestige Cervical Disc after device approval as per device
indication. This device is indicated indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable radiculopathy and/or myelopathy. Intractable radiculopathy and/or myelopathy should present with at least one of the following items producing symptomatic nerve root and/or spinal cord compression which is documented by patient history (e.g., pain [neck and/or arm pain], functional deficit, and/or neurological deficit), and radiographic studies (e.g., CT, MRI, x-rays, etc.): 1) herniated disc, and/or 2) osteophyte formation. The PRESTIGE 9 device is implanted via an open anterior approach.
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
n/a
Actual Number of Sites Enrolled
n/a
Patient Followup Rate
n/a
Final Safety Findings
Since the PMA approval date of July 16, 2007 through May 13, 2012, a cumulative
total of implants have been sold in the U.S., a cumulative total of MDRs have been reported for implants sold in the U.S., and a cumulative total of MDRs have been reported for instruments sold in the U.S.
A Kaplan-Meier analysis was conducted on adverse events and second surgeries reported from PMA approval on July 16, 2007 through May 13, 2012. events were included in the time-to-adverse event analysis, with cumulative event rates of 0.413% at months, 0.479% months, 0.479% months, and 0.598%. events were included in the time-to-second surgery analysis, with cumulative event rates of 0.124% at months, 0.190% at months, 0.190% at months, and 0.309% at months and beyond following surgery
Final Effectiveness Findings
n/a
Study Strengths and Weaknesses
The study duration was for 5 years after PMA approval, allowing time to monitor adverse
events and complaints received by the company for the device in the postmarket 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. Therefore, the true number of devices implanted during the 5-year study period is unknown.
Recommendations for Labeling Changes
A labeling change based on the results from this study is not recommended because the
study was designed as a surveillance study.
Enhanced Surveillance
Schedule
Report Schedule
Report Date Due
FDA Receipt Date
Reporting Status
6 month report (Enhanced Surveillance Study)
01/14/2008
01/14/2008
On Time
1 Year report (Enhanced Surveillance Study)
07/31/2008
07/15/2008
On Time
18 month report (Enhanced Surveillance Study)
01/13/2009
01/12/2009
On Time
2 year report (Enhanced Surveillance Study)
07/15/2009
07/21/2009
Overdue/Received
3 year report (Enhanced Surveillance Study)
07/15/2010
07/20/2010
Overdue/Received
4 year report (Enhanced Surveillanced Study)
07/15/2011
07/18/2011
Overdue/Received
5 year report (Final)(Enhanced Surveillance Study)
