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

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EMBLEM S-ICD Electrode Model 3501 PAS


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General
Study Status Progress Adequate
Application Number P110042 S077/ PAS001
Study Name EMBLEM S-ICD Electrode Model 3501 PAS
General Study Protocol Parameters
Study Design Other Study Design
Data Source External Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Primary analyses will use existing data sources from patients implanted with the EMBLEM S-ICD Electrode Model 3501 and represented in the following databases:
NCDR: ICD Registry;
LATITUDE NXT Patient Management System;
CMS Claims Database; and
National Death Index (linage to NCDR patients).
Each database is associated with a unique, independently-powered co-primary endpoint. Comparisons will be made to the predecessor EMBLEM S-ICD Electrode Model 3401. An unpowered secondary analysis will be performed using patients from Truven Marketscan Database (private insurance claims).
Study Population Description Patients will come from the US implant population with EMBLEM S-ICD Electrode Model 3501 whose data are captured in one of the databases utilized for this study.
Sample Size The primary analysis cohorts will consist of consecutive patients implanted with EMBLEM S-ICD Electrode Model 3501 identified in the following databases:

NCDR ICD Registry (N=2,100);

LATITUDE NXT Patient Management System (N=2,000);

CMS Claims Database (N=2,100); and

National Death Index linkage to NCDR patients (N=2,100).

The sample sizes given in the parentheses were calculated based on the provisional statistical assumptions given in Table 1-2 and will be updated based on PAS data for the EMBLEM S-ICD Electrode Model 3401. The sample sizes will be re-estimated and patients will be added if needed to ensure 90% power is maintained.
Data Collection Primary Endpoints:

NCDR: The first primary endpoint evaluates the rate of Model 3501 implant and periprocedural complications.

Remote Monitoring (LATITUDE NXT): The second primary endpoint evaluates the five-year rate of Model 3501 EMBLEM S-ICD Electrode integrity alerts.

Administrative Claims (CMS): The third primary endpoint evaluates the five-year rate of Model 3501 EMBLEM S-ICD Electrode complications requiring reoperation or hospitalization.

National Death Index: The fourth primary endpoint evaluates the five year rate of Model 3501 EMBLEM S-ICD Electrode patient deaths from any cause.

Secondary Endpoint:

Administrative Claims (Truven): The secondary endpoint evaluates the five-year rate of Model 3501 EMBLEM S-ICD Electrode complications requiring reoperation or hospitalization.
Follow-up Visits and Length of Follow-up 5 years
Interim or Final Data Summary
Interim Safety Information Number of study sites enrolled The study utilizes existing real-world data sources, and hence it does not require site enrollment.

Number of subjects enrolled As of 24 January 2018, a total of 140 subjects implanted with a Model 3501 Electrode were accrued in the Latitude database for one of the primary endpoints, i.e., structural electrode complications.

Follow-up rate Among the 140 subjects, 39 and 12 subjects completed 30-day and 60-day follow-ups, respectively. Follow-up rates in this reporting period are not meaningful due to the lack of data.

Summary of Interim Results As of 24 January 2018, there was no high-impedance alert found in the 140 subjects.

Strengths and Weaknesses As of 24 January 2018, there has been no adverse event among the 140 subjects. No weakness can be discussed due to the early phase of the study and the lack of data.



EMBLEM S-ICD Electrode Model 3501 PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 03/30/2018 03/30/2018 On Time
one year report 09/29/2018 09/28/2018 On Time
18 month report 03/30/2019    
two year report 09/29/2019    
three year report 09/28/2020    


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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