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U.S. Department of Health and Human Services

Post-Approval Studies

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Post-Approval Studies

  • 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.


Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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Application Number P100023
Current Protocol Accepted 04/22/2011
Study Name PERSEUS Workhorse and Small Vessel (SV)
Study Status Completed
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Final Study Results
Actual Number of Patients Enrolled PERSEUS Workhorse: 1,249

PERSEUS Small Vessel: 223

Actual Number of Sites Enrolled PERSEUS Workhorse: 90

PERSEUS Small Vessel: 28

Patient Followup Rate PERSEUS Workhorse: 92% at five years

PERSEUS Small Vessel: 93.7% at five years

Final Safety Findings PERSEUS Workhorse: Results at five years:

-MACE (cardiac death, MI, TVR)

TAXUS Express (18.2%) and TAXUS   show the rest ...
Final Effectiveness Findings PERSEUS Workhorse: Results at five years:

-Target lesion failure (TLF)

TAXUS Express (13.7%) and TAXUS Element   show the rest ...
Study Strengths and Weaknesses The PERSEUS Workhorse study was prospective, randomized, controlled, single-blind, non-inferiority trial with a sample size   show the rest ...
Recommendations for Labeling Changes A labeling change is recommended to add a summary of the post-approval study results including   show the rest ...

PERSEUS Workhorse and Small Vessel (SV) Schedule

Report Schedule
Date Due
FDA Receipt
Reporting Status
2 year report 04/21/2013 05/18/2011 On Time
3 year report 04/21/2014 05/16/2012 On Time
4 year report 04/21/2015 04/29/2013 On Time
Final Report 04/20/2016 04/08/2014 On Time

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