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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Enhanced Surveillance


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General
Application Number P010031 S104/ PAS001
Current Plan Approved 08/28/2008
Study Name Enhanced Surveillance
General Study Protocol Parameters
Study Design Enhanced Surveillance
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The post-approval study is a prospective, non-randomized, combined cohort of subjects followed in two other studies. Data from the combined cohort are used prospectively to assess performance of the algorithm.
Study Population Description Study population same as approved product. This device is a software algorithm designed to identify potential RV-Tip to RV-Ring pace/sense electrode issues earlier than contemporary out-of-range impedance criteria. The RVLIA algorithm uses two different criteria to determine potential lead noise. It uses data from the ventricular sensing integrity counter (SIC) and non-sustained VT episodes (NST) to determine potential noise and also looks at the RV pacing lead impedance values.
Sample Size 3873 subjects from multiple centers in 2 cohorts
Data Collection Data are collected via review of the databases using the device algorithm. Triggers associated with the algorithm are reviewed. Lead fractures are confirmed.
Follow-up Visits and Length of Follow-up The cohort is followed for two years.
Final Study Results
Interim Safety Information No adverse events or death information are collected for this study.
Number of Patients 1779
Number of Sites n/a
Follow-up Rate n/a
Safety Findings n/a
Effect Findings Of 41 events, 39 were detected by LIA algorithm, giving an estimated sensitivity of 95.1% (95% IC 83.5%-99.4). The inappropriate shock rate was 21%.



Of 47 LIA triggers, there were eight false-positive alerts increase without lead modification as indicated in the Device Registration System. . The false-positives included two gradually increasing impedance, two T-wave oversensing cases, and one each caused by a header-connector problem, hypothermic ventricular fibrillation during cardiac arrest at cardiac surgery, ventricular fibrillation storm, and one case adjudicated as unknown with abrupt impedance. The estimated number of false positive LIA triggers based on the retrospective analysis was 0.00269 per patient-year.

Strengths & Weaknesses Not all products were returned for the Return Product Analysis. Of 47 LIA triggers, 21 (47%) of the products were not analyzed, where 15 were not returned and 6 were listed as ¿no record¿.
Label Changes Labeling changes should be accomplished in accordance with the findings of the PAS.


Enhanced Surveillance Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 02/26/2009 03/03/2009 Overdue/Received
1 year report 08/28/2009 08/31/2009 Overdue/Received
18 month report 02/26/2010 02/25/2010 On Time
2 year report 08/28/2010 08/23/2010 On Time
Final Report 03/14/2011 03/14/2011 On Time
response to R22 RDEF (final report) 11/01/2011 10/31/2011 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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