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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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Siello Pacing Lead Study


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General
Study Status Completed
Application Number P950037 S156/ PAS001
Date Current Protocol Accepted 04/15/2019
Study Name Siello Pacing Lead Study
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 Design Description 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 Description 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%.
Data Collection 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
Actual Number of Patients Enrolled 1,015 patients implanted with a Siello lead on or between March 13, 2013 and July 20, 2015.
Actual Number of Sites Enrolled N/A
Patient Follow-up Rate N/A
Final Safety Findings There were a total of 33 complications identified in 33 out of 1,841 Siello leads as attributable or possible attributable to the device. Of the 1174 evaluable patients for this endpoint, there were 33 Siello leads with a qualifying event, resulting in an CFR of 97.19%.
Final Effect Findings N/A
Study Strengths & Weaknesses This study’s use of real-world data captures a large representative assessment of device performance. While data granularity is limited, the study confirms there are no significant safety concerns with the device’s long term performance.
Recommendations for Labeling Changes Yes


Siello Pacing Lead Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/07/2016 12/07/2016 On Time
18 month report 12/07/2017 12/04/2017 On Time
interim report 12/07/2018 11/28/2018 On Time
interim report 10/15/2019 10/15/2019 On Time
interim report 10/15/2020 10/15/2020 On Time
final report 10/15/2021 10/15/2021 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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