f Post-Approval Studies (PAS) Database
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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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Protego DF4 Post Approval Registry


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General
Study Status Completed
Application Number /
Requirement Number		 P050023 S076/ PAS001
Date Original Protocol Accepted 07/03/2014
Date Current Protocol Accepted 04/15/2019
Study Name Protego DF4 Post Approval Registry
Device Name ILESTO/IFORIA 5/7 VRT/DRT ICD'S, ILESTO/IFORIA 5/7 HF-T CRT-D
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Admin Database
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs
Detailed Study Protocol Parameters
Study Objectives This study is designed to gather safety data on BIOTRONIK’s lead using active monitoring of Medicare fee-for-service (FFS) claims data. The design is a prospective, single-arm, non-randomized, observational cohort study utilizing real world data.
Study Population Patients who are implanted with the lead and are in the beneficiary match population for the claims data are included in the patient population.
Sample Size 750 minimum evaluable sample required to demonstrate superiority to a complication-free rate of 92.5%.
Key Study Endpoints The purpose of primary endpoint 1 is to evaluate the overall incidence of complications attributable to the lead through 5 years post-implant.
Follow-up Visits and Length of Follow-up 5 years post-implant
Interim or Final Data Summary
Interim Results Th
Actual Number of Patients Enrolled A total of 2,702 patients implanted with 2,721 Protego leads met all study inclusion and no study exclusion criteria and are included in the Protego claims cohort for this final report.
Overall, 37.10% (2,702/7,283) of patients implanted with a Protego lead during the PAS enrollment period were matched as unique beneficiaries in the CMS database and had both FFS Medicare coverage during the month of the Protego lead implant and a Medicare claim during the analysis period.
Actual Number of Sites Enrolled N/A
Patient Follow-up Rate N/A
Final Safety Findings 56 complications were identified to meet the primary endpoint. The estimated freedom from complications at 1,802 days is 97.18%, meeting 5 year rate >92.5%. There were no DF4 header connector malfunctions.
Final Effect Findings N/A
Study Strengths & Weaknesses The study successfully enrolled and matched patients to Administrative Claims data, permitting larger enrollments than traditional post approval study clinical follow up. Since event rates were rare, the CMS cell suppression policy does not permit additional granular information to be included.
Recommendations for Labeling Changes Yes


Protego DF4 Post Approval Registry Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/01/2015 01/29/2015 Overdue/Received
one year report 07/03/2015 06/26/2015 On Time
18 month report 01/01/2016 12/31/2015 On Time
two year report 07/02/2016 06/28/2016 On Time
three year report 07/02/2017 06/28/2017 On Time
four year report 07/02/2018 07/02/2018 On Time
five year report 07/02/2019 07/01/2019 On Time
six year report 10/15/2019 10/15/2019 On Time
seven year report 10/15/2020 10/15/2020 On Time
8 year report 10/15/2021 10/15/2021 On Time
final report 10/15/2022 10/14/2022 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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