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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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Externalization and Abrasion Sub-Study


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General
Study Status Completed
Application Number /
Requirement Number		 P950022 S085/ PAS002
Date Original Protocol Accepted 02/21/2014
Date Current Protocol Accepted 02/21/2014
Study Name Externalization and Abrasion Sub-Study
Device Name OPTISURE
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs
Interim or Final Data Summary
Actual Number of Patients Enrolled 477 subjects from the main study were consented and enrolled in the sub study
Actual Number of Sites Enrolled 60 clinical sites
Patient Follow-up Rate As of the cut-off date for this report, in the sub-study a total of 370 subjects have completed the 12 month visit, 335 subjects have completed the 24 month, 279 subjects have completed the 36 month, 233 have completed the 48 month follow-up visit, and 9 have completed the 60 month visit, which includes some of the initial cinefluoroscopy evaluations for the sub-study.
Final Safety Findings There were a total of 5 adverse events (3 complications and 2 observations) reported post Optisure lead interventions. The complications were related to the following: Lead Dislodgement or Migration and Pericardial Effusion. The observations were related to the following: Bleeding and other.
Final Effect Findings There are 10 cases of Optisure RV leads that were adjudicated by the Electrical Data Adjudication Committee (EDAC). Of the 10 cases, 1 was adjudicated as having electrical dysfunction. The others had reasons other than the integrity of the lead as the cause for electrical abnormalities. The sponsor states that as of the cutoff date of this report, zero externalized conductors, zero visual lead anomalies and zero other insulation anomalies have been identified by the CAC for the Optisure RV leads.
Study Strengths & Weaknesses There has been no incidence of externalized conductors (EC) or visual lead anomalies (VLA) in Optisure leads as measured throughout >4 years of follow-up in the sub-study.
Recommendations for Labeling Changes No


Externalization and Abrasion Sub-Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
two year report 08/21/2016 08/18/2016 On Time
three year report 03/21/2017 03/22/2017 Overdue/Received
four year report 03/21/2018 03/20/2018 On Time
five year report 03/21/2019 03/20/2019 On Time
six year report 03/20/2020 03/19/2020 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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