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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-MR conditional Tachy Therapy Systems Stud


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General
Study Status Progress Adequate
Application Number P890003 S338/ PAS001
Study Name OSB Lead-MR conditional Tachy Therapy Systems Stud
General Study Protocol Parameters
Study Design Active Surveillance
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description MR conditional tachyarrhythmia therapy 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 MR conditional tachyarrhythmia therapy system and followed in the Medtronic CL network with de-identified data accessibility.
Sample Size A sample size of 50 patients with a true VF episode will produce a 2-sided 95% confidence interval upper bound for the estimate of approximately 11% (i.e. no more than one VF that will have = 5 second detection delay).

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

¿ CL participation estimates:

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

o An estimated 69% of US CRT-D implants currently enroll in CL and approximately 55% of those patients regularly transmit device data.

¿ Applying CL use/transmission rate to the current estimated US sales projections:

o An estimated 10,979 MR ICD System Evera MRI patients will be actively monitored in CL within three years of product approval.

o An estimated 14421 MR CRT-D system patients will be actively monitoring within three years of product approval

¿ Annual MRI scan rate of 9%, an estimated 4143 patients will have at least one MRI scan within approximately 4 years post product approval.

Annual true VF/PMVT episode rate of approximately 2%, based on episode adjudication data collected in Medtronic PainFree SST and Shockless studies. Year 1 Year 2 Year 3

Projected US MR ICD Sales per year

6450

10000

11700

Estimated # of Patients

with CareLink Transmissions (0.65|0.6)

2516

3900

4563

Projected US MR CRT-D Sales per year

12000

14000

12000

Estimated # of Patients

with CareLink Transmissions (0.69|0.55)

455

5313

455

Total Estimated (MR ICD + MR CRT-D) with

CareLink Transmissions

7070

9213

9117

MRI after 1 year (0.09 )

635

829

819

MRI after 2 years (0.172)

1214

1583

MRI after 3 years (0.246)

1741

Total Estimated # of Patients with an MRI

4143

Per the above assumptions, a statistical simulation indicates that approximately 40 to 97 patients will have 40 to 194 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 MR conditional tachyarrhythmia therapy system following MRI exposure.

No VF/PMVT detection delays of = 5 seconds were observed in the Evera MRI IDE study. 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 50 patients with VF episodes is 2%.

Other endpoints:

1) Multiple MRI Scans

Data regarding the number of patients presumed to have had 2 or more scans will be provided. The time stamp of a when a device was last programmed to the MRI compatible mode (i.e. SureScan mode) will be tracked from CL transmission to transmission. Any change in the time stamp of an MR mode safe switch of greater than 20 minutes will indicate the occurrence of an MRI. The estimate of patients receiving multiple MRI scans will include all patients regardless if the patient has experienced a VF episode.

2) LV Pacing Capture Threshold

Left ventricular lead Pacing Capture Threshold (PCT) values are automatically stored by the device through the Left Ventricular Capture Management feature and obtained through CareLink transmissions. Pre-MRI and post-MRI4 LV lead PCT measurements obtained through CareLink will be summarized for MR CRT-D patients. Summary statistics will be presented separately for pre-MRI and post-MRI PCT measurements. It is anticipated that PCT measurements from approximately 2,444 patients with a MRI will be presented.
Follow-up Visits and Length of Follow-up 50 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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