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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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OptiSure Lead Post Approval Study

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Study Status Completed
Application Number P950022 S085/ PAS001
Date Current Protocol Accepted 05/20/2020
Study Name OptiSure Lead Post Approval Study
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source Admin Database
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The purpose of this study is to collect long term safety data of Optisure family of high voltage leads. This study transitions the
Optisure Post Approval Study from a traditional prospective study design to a real world evidence data method for post market
monitoring of the Optisure lead. This method merges multiple real world datasets to assess the Optisure lead performance in a larger
patient population. The proposed method matches patient population datasets from Abbott and Centers for Medicare and
Medicaid Services (CMS) in order to generate data that can be used to evaluate safety of leads in a post market setting.
Study Population Description All patients who had an implant of the Optisure Lead, meet inclusion/exclusion criteria, and link to Medicare FFS claims will be
included in the analysis of this endpoint.
Sample Size Assuming the time to first complication follows an exponential distribution and the complication-free survival at 5 years is 95%, a
minimal sample size of 645 patients provides 80% power to reject the null hypothesis of 92.5% complication-free survival years at the 5%
significance level.
It is estimated that 4287 patients with Optisure lead implants will meet inclusion/exclusion criteria and link to Medicare FFS claims for this
study, which greatly exceeds the minimal required sample size.
Data Collection The primary outcome measure is the complication free survival rate at five years for complications related to the Otisure leads.
The secondary outcome measure is a rate of cardiac tamponade or cardiac perforation events.
Follow-up Visits and Length of Follow-up The study completion is 5 years after final implant, December 2020. The data retention period will be for 2 years after the submission of the final report.
Interim or Final Data Summary
Actual Number of Patients Enrolled 4,023 eligible subjects with 4,028 Optisure leads
Actual Number of Sites Enrolled N/A
Patient Follow-up Rate N/A
Final Safety Findings The rate of freedom from Optisure lead related complications was 97.3% for the worst-case scenario
Final Effect Findings The rate of all cardiac tamponade and cardiac perforation events during the study time period was 44 events in 28 patients (0.6960% of patients with event) and 7 events in 7 patients (0.1740% of patients with event), respectively
Study Strengths & Weaknesses Overall, the results demonstrate the safety of the Optisure family of leads within a large patient population using a real-world data analysis approach. The rate of cardiac tamponade and cardiac perforation events in the Optisure RWE Study remains comparable to what was
observed and reported in the Optisure PAS 72-month clinical study report for Optisure lead related cardiac tamponade and perforation complications. The benefit to risk ratio associated with the Optisure leads remains favorable as determined using RWE analysis. No new risks were identified in the course of the RWE Study.
Recommendations for Labeling Changes Yes

OptiSure Lead Post Approval Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 08/22/2014 08/25/2014 Overdue/Received
one year report 02/21/2015 02/20/2015 On Time
18 month report 08/22/2015 08/24/2015 Overdue/Received
two year report 02/21/2016 02/23/2016 Overdue/Received
three year report 03/21/2017 03/20/2017 On Time
four year report 03/20/2018 03/20/2018 On Time
five year report 03/20/2019 03/20/2019 On Time
six year report 03/20/2020 03/19/2020 On Time
final Report 08/21/2021 07/30/2021 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

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