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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) 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 Progress Adequate
Application Number P090029 S003/ PAS002
Date Current Protocol Accepted 07/12/2019
Study Name PRESTIGE LP 2-Level Metal Concentrations
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is intended to study the long term performance of the

Prestige LP Cervical Disc. These observations include all AE,

including device related AE, HO, reoperations/revisions/removals

and metal ion related outcomes due to the new material. This

incorporates 10 year follow-up for IDE cohort as well as

commercial use.
Study Population Description The study population is limited to subjects with Prestige LP at two contiguous levels.

Sample Size 30 subjects
Data Collection 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 1 year following approval of S012
Interim or Final Data Summary
Interim Safety Information Summary of Interim Results Conclusions cannot yet be drawn.

Strengths and Weaknesses Study has had trouble enrolling patients.

Actual Number of Patients Enrolled 15 subjects enrolled, 9 subjects have been treated (8 in report). (6 subjects failed screening, 1 dropped out)
Actual Number of Sites Enrolled 5
Patient Follow-up Rate 71.4% @ 3mo; 50% @ 6mo.


PRESTIGE LP 2-Level Metal Concentrations Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/05/2017 12/20/2016 On Time
one year report 07/07/2017 07/03/2017 On Time
18 month report 01/05/2018 12/15/2017 On Time
two year report 07/07/2018 06/26/2018 On Time
three year report 07/07/2019 06/24/2019 On Time
four year report 07/06/2020    
five year report 07/06/2021    
final report 08/30/2021    


Contact Us

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

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