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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 MRI S-ICD Pt Mgmt System Surv PAS

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Study Status Completed
Application Number P110042 S058/ PAS001
Study Name EMBLEM MRI S-ICD Pt Mgmt System Surv PAS
General Study Protocol Parameters
Study Design Active Surveillance
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Non-randomized, observational surveillance effort using a remote data collection database to identify spontaneous episodes of VF

following possible clinical MRI exposure. Identified episodes will be used to assess sensing and detection via time-to-therapy. All data

will be collected via Boston Scientific’s Latitude NXT Patient Management System and de-identified for analysis.
Study Population Description All Boston Scientific S-ICD systems that have been placed into MRI Protection Mode and transmit data to the Latitude NXT Patient

Management System. Subjects to be included will meet two criteria:

Possible MRI exposure (as indicated by MRI Protection Mode having been enabled), and

At least one documented spontaneous treated episode of VF subsequent to possible MRI exposure
Sample Size 25 subjects will contribute to this data analysis.

Assuming a time to therapy of 20.0 seconds (S),1 a sample size of 25 episodes will produce a 95% confidence interval of [18.0, 22.0] S.

The following assumptions were used to define the scope and duration:

US sales projections indicate that an estimated 8,600 BSC SICD

Systems will be implanted annually for the next 5 years.

An estimated 70% of S-ICDs in the US will enroll and regularly transmit device data through the Latitude NXT Patient Management System.

The annual incidence MRI scans in ICD patients is approximately 10%

Based on episode data from the S-ICD Clinical Investigation, the annual incidence of VF is approximately 1-2% of patients per year.

Per the above assumptions, it will take approximately 5 years to complete the project.
Data Collection Primary Endpoints:

The mean, median and standard deviation of time to therapy will be assessed for the first appropriately treated spontaneous episode of

VF following placement into MRI Protection Mode.

The time to therapy is defined as the interval starting when the rate of the VF is greater or equal to the lowest programmed zone

(Conditional Zone) and measured until the start of the shock marker.

Additional Observational Endpoints:

Number of devices programmed to MRI Protection Mode

Number / type of spontaneous episodes of VT/VF following placement in MRI Protection Mode

Last shock impedance for episodes of VT/VF that occur subsequent to placement in MRI Protection Mode

In the event that the calculated time to therapy exceeds 30 seconds, additional treated episodes from the same device prior to the MRI

will be identified. This will allow within-patient time-to-therapy comparisons before and after the device is programmed into MRI

Protection Mode. Additionally, the clinic and enrolling physician will be queried in order to identify the patient and provide an

opportunity to consent to providing additional data, including:

Details around the programming of MRI Protection Mode

Details of the MRI

Other pertinent medical history information that might explain the long time to therapy
Follow-up Visits and Length of Follow-up 5 years post-approval
Interim or Final Data Summary
Actual Number of Patients Enrolled 34 subjects included in the endpoint analysis
Actual Number of Sites Enrolled 0 sites – study was performed using data collected from Latitude NXT Patient Management Systems transmissions
Patient Follow-up Rate No patient follow-up required by study design due to data collection method using home monitor data.
Final Safety Findings The time to therapy was assessed for the first appropriately treated spontaneous episode of ventricular fibrillation (VF) following placement into MRI Protection Mode.
Final Effect Findings N/A study just had the endpoint listed above
Study Strengths & Weaknesses Study used real-world evidence sources which eliminated the need for the use of sites for data collection. The study design allowed the study to be conducted faster and with more patients than planned (25 planned). The weakness of the study is that it was reliant on home monitor data and did not have the full follow-up with in-person patient visits to identify potential other signals unrelated to the time to therapy endpoint.
Recommendations for Labeling Changes No labeling change is recommended as the performance is in line with the performance observed during the premarket study.

EMBLEM MRI S-ICD Pt Mgmt System Surv PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 02/06/2017 02/06/2017 On Time
one year report 08/08/2017 07/31/2017 On Time
18 month report 02/14/2018 02/14/2018 On Time
two year report 08/08/2018 08/01/2018 On Time
final report 08/08/2019 08/07/2019 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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