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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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Extended Follow-Up


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General
Study Status Completed
Application Number P090029 / PAS001
Date Current Protocol Accepted 07/24/2014
Study Name Extended Follow-Up
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Interim or Final Data Summary
Actual Number of Patients Enrolled 280 subjects in the Investigational (INV) cohort, 30 in the Metal Ion cohort, and 24 in the Continued Access cohort.
Actual Number of Sites Enrolled 20 clinical sites have received IRB approval, 15 of them have been enrolled.
Patient Follow-up Rate INV follow-up rate was reported as 82.2% and 90.9% for 84 months (± 3 months) and 120 months (± 6 months), respectively.
Final Safety Findings No alarming safety trends were identified. However, there is a need to further address higher cumulative rate for vascular adverse events in INV group vs. controls and explore its possible reasons other than by a chance finding.
Final Effect Findings Bayesian analyses showed a posterior probability of non- inferiority of essentially 100.0% and a posterior probability of superiority of 98.5% for overall success without Functional Spine Unit (FSU) and a posterior probability of non-inferiority of 94.5% with FSU. Both non-inferiority and superiority of the Prestige lp disc over the control treatment were established for overall success without FSU. Non-inferiority of the Prestige lp disc was missed by 0.5% for overall success with FSU (based on the success criteria of posterior probability of 95%) due to the low rate of the FSU success in the Prestige lp disc group vs. control (83.8% vs. 96.9%, respectively). Angular motion among subjects with the Prestige lp disc was higher at superior, but not inferior, adjacent level.
Study Strengths & Weaknesses This Extended Follow-up study successfully demonstrated non- inferiority of overall Prestige LP disk performance compared to comparator. However, longer-term device performance needs further evaluation, especially taking into account that this follow-up study was based on historical control and therefore lacked comparator data beyond the 84-month timepoint.
Recommendations for Labeling Changes Labeling changes were recommended to reflect that FSU non- inferiority in the INV group was missed at the 84 months as well as refer to some other study findings such as higher cumulative rate for vascular adverse events in the INV group.





Extended Follow-Up Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/22/2015 01/22/2015 On Time
one year report 07/24/2015 07/24/2015 On Time
18 month report 01/22/2016 01/19/2016 On Time
two year report 07/23/2016 07/20/2016 On Time
unscheduled report 07/24/2017 07/24/2017 On Time
Final Report 11/28/2017 11/17/2017 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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