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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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Extended Follow-up of IDE Subjects


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General
Study Status Study Pending
Application Number P200022 / PAS001
Date Current Protocol Accepted 05/26/2021
Study Name Extended Follow-up of IDE Subjects
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Objective: To evaluate the 5-year long-term safety and effectiveness of the Simplify Cervical Artificial Disc in subjects with symptomatic cervical

radiculopathy with or without neck pain or myelopathy due to a single level abnormality localized to the level of the disc space that is

unresponsive to conservative management.



Design: A continuation of the prospective, multi-center, historically controlled IDE study population to evaluate the long-term safety and

effectiveness of the Simplify Cervical Artificial Disc.
Study Population Description Investigational Device: Simplify Cervical Artificial Disc

Historical Control: Anterior Cervical Discectomy and Fusion (ACDF)
Sample Size 142 Simplify Cervical Artificial Disc IDE subjects and 106 historical ACDF control subjects are elgible for for the PAS study
Data Collection Safety Endpoints:

• Collection and evaluation of all adverse events for severity and device and/or procedure-relatedness

• Evaluation of device failure (device breakage, migration, or mechanical failure) as defined in Radiographic Evaluation Protocol

• Subsequent surgical procedures (revision, removal, reoperation, or supplemental fixation) at the index level

• Neurologic evaluation – investigational device only

• Dysphagia Handicap Index (DHI) – investigational device only

Effectiveness Endpoints:

• Neck Disability Index (NDI) assessment

• Radiographic evaluation

• VAS pain assessments (neck and arm; neck, left arm and right arm (investigational device only))

• Treatment satisfaction

• SF-12 Health Survey
Follow-up Visits and Length of Follow-up 5 years


Extended Follow-up of IDE Subjects Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
One year report 09/18/2021   Overdue
Two year report 09/18/2022    
Three year report 09/18/2023    


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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