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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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PRESTIGE LP 2-Level Metal Concentrations


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General
Study Status Completed
Application Number /
Requirement Number		 P090029 S003/ PAS002
Date Original Protocol Accepted 02/13/2018
Date Current Protocol Accepted 07/12/2019
Study Name PRESTIGE LP 2-Level Metal Concentrations
Device Name PRESTIGE LP(TM) CERVICAL DISC
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Objectives a one-arm cohort study
Study Population Patients diagnosed with degenerative disc disease and two (2) contiguous levels
in the cervical spine from C3 to C7 and implanted with Prestige LP
Sample Size 30 subjects
Key Study Endpoints The main study end-point is assessment of metal concentrations (titanium, vanadium, and aluminum) and their changes over time in blood serum.
Additional Study endpoints are as follows:
Overall success rate with overall success defined as:
NDI score improvement of at least 15 points from baseline
Maintenance or improvement in neurological status
No serious AE classified as implant associated/related or implant/surgical procedure associated/related
No secondary surgical procedure classified as a treatment “failure”
o Neck Disability Index (NDI) score improvement from baseline;
o Neurological Status change from baseline
o Neck and Arm Pain score change from baseline
o Safety of the PRESTIGE LP™ Cervical Disc as reported through AEs and secondary surgeries.
Follow-up Visits and Length of Follow-up 12 months
Interim or Final Data Summary
Actual Number of Patients Enrolled 25 subjects enrolled, 26 subjects have been treated and in follow-up. (8 subjects failed screening, 1 dropped out)
Actual Number of Sites Enrolled 5
Patient Follow-up Rate 72% @ 3mo; 68% @ 6mo; 79.2% @ 12mo.
Final Safety Findings No major safety concerns observed from limited study
Study Strengths & Weaknesses Protocol modified to increase enrollment results in some confounding
factors, small sample size. COVID19 pandemic also introduced follow-up
challenges and reduced data points.


PRESTIGE LP 2-Level Metal Concentrations Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 01/05/2017 12/20/2016 On Time
1 year report 07/07/2017 07/03/2017 On Time
18 month report 01/05/2018 12/15/2017 On Time
2 year report 07/07/2018 06/26/2018 On Time
3 year report 07/07/2019 06/24/2019 On Time
4 year report 07/06/2020 06/22/2020 On Time
5 year report 07/06/2021 07/07/2021 Overdue/Received
6 year report 07/07/2022 07/07/2022 On Time
final report 04/27/2023 04/27/2023 On Time


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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