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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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OSB Lead-Evera MRI System PAS


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General
Study Status Study Pending
Application Number P890003 S329/ PAS001
Study Name OSB Lead-Evera MRI System PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Evera MRI systems enrolled in the Medtronic CareLink® (CL) Network will be used to prospectively assess spontaneous VF episode detection following MRI exposure.
Study Population Description All patients who will be implanted with an Evera MRI system and followed in the Medtronic CL network with de-identified data accessibility.
Sample Size This study will capture all Evera MRI systems enrolled in the Medtronic CareLink Network, from the date of device approval through four years post-approval, to prospectively identify and assess spontaneous Ventricular Fibrillation (VF) episode detection following MRI exposure.It is estimated that 25 patients with a true VF episode following MR exposure will be identified through Medtronic CL Network, during this four year study period. An MRI is considered to have been performed if the device MRI-compatible mode (SureScan mode) has been enabled and remains in the MRI-compatible mode for at least 20 minutes.

A sample size of 25 patients with a true VF episode will produce a 2-sided 95% confidence interval with upper bound equal to 0.204 when the sample proportion is 0.040 (i.e. no more than one VF that will have ≥ 5 second detection delay in 25 patients).

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

 An estimated 65% of US ICD implants currently enroll in CL and approximately 60% of those patients regularly transmit device data.

 Applying CL use/transmission rate to the current estimated US sales projections for the Evera MRI system, an estimated 10,979 Evera MRI patients will be actively monitored in CL within three years of product approval.

 Annual MRI scan rate of 9%, an estimated 1,699 patients will have at least one MRI scan within approximately 4 years post product approval.

 Based on episode adjudication data collected in Medtronic PainFree SST and Shockless studies, annual true VF/PMVT episode rate is approximately 2%

Per the above assumptions, a statistical simulation indicates that approximately 10 to 49 patients will have 10 to 98 true VF/PMVT detected episodes, following an MRI, within

approximately 5 years of product approval.
Data Collection Primary Endpoints:

To characterize the proportion of episodes with ≥ 5 seconds VF detection delay in the Evera MRI system following MRI exposure.

A previous Medtronic study estimated a 0.08% detection delay rate in non-MRI patients based on a cohort of 1177 induced VF episodes. Therefore, the probability of observing at least one VF/PMVT episode with ≥ 5 seconds detection delay in the study cohort of 25 patients with VF episodes is 2%.
Follow-up Visits and Length of Follow-up 25 patients with a VF episode following MR exposure have been identified or 5-years post-approval, whichever comes first




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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