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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-ProMRI ICD/CRT-D System


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General
Study Status Progress Adequate
Application Number P050023 S101/ PAS001
Date Current Protocol Accepted  
Study Name OSB Lead-ProMRI ICD/CRT-D System
General Study Protocol Parameters
Study Design Enhanced Surveillance
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Design Description Retrospective, observational, post-approval study.



To gather additional data to assess VF episode detection following MRI exposure as a condition of FDA approval. Secondarily, this post-approval study will provide additional data on the MRI mode programming following the MRI and LV pacing threshold changes between pre-MRI and one-month post-MRI.

Study Population Description All subjects implanted with a ProMRI ICD/CRT-D system and enabled with Home

Monitoring® in the United States

Sample Size Primary Objective 1:



An estimated 75% of US ICD implants are registered for Home Monitoring® and approximately 75% of those subjects regularly transmit device data. Applying these Home Monitoring® registration and transmission rate to the estimated US sales of the ProMRI ICD system, approximately 8437 ProMRI ICD subjects will be actively

monitored by Home Monitoring® within 3 years of product approval. With an estimated annual MRI scan rate of 10%, approximately 1702 will have at least one MRI scan

within 4 years post product approval. Annual true VF episode rate is approximately 2%. Applying the estimated 2% to the expected annual implant and MRI rates, results in approximately 16-34 subjects with a true VF episode occurring after an MRI scan within 5 years post-approval.



Primary Objective 2:



With a = 0.025, 1 - ß = 80%, an anticipated pacing threshold success rate of 99%, a performance goal of 95% and a one-sided exact binomial test, a sample size of n = 145 evaluable subjects with LV leads is required.

Data Collection Primary Objective:

Characterize VF detection following MRI exposure, as determined by an independent Clinical Events Committee, to ensure there is no delay in VF detection attributable to the MRI scan.



MRI induced Left Ventricular pacing threshold changes between Pre-MRI and One-Month post-MRI.



Secondary Objectives:



Characterize appropriate tachycardia detection and ICD therapy programming following MRI exposure.



Characterize changes in LV sensing and pacing impedance between pre-MRI and one-month post-MRI.

Follow-up Visits and Length of Follow-up When 50 patients implanted with the ProMRI ICD system with a documented post-MRI VF episode have been identified or 5-years post-approval, which ever comes first


OSB Lead-ProMRI ICD/CRT-D System Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/08/2017 05/02/2017 On Time
one year report 02/08/2018 11/02/2017 On Time
18 month report 08/08/2018    


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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