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

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LIA in Non-MDT Leads Surveillance Update Analysis


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General
Application Number P010031 S344/ PAS001
Current Plan Approved 09/25/2013
Study Name LIA in Non-MDT Leads Surveillance Update Analysis
General Study Protocol Parameters
Study Design Retrospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This analysis plan is created to leverage data that is already available as part of the Medtronic CareLink remote management system. An RV LIA trigger requires 2 of 3 components to be satisfied within 60 days: abrupt pace sense impedance change, frequent extremely short R-R intervals, and rapid non-sustained VT episodes. The save-to-disk file associated with each of these alert (RV LIA or impedance nominal threshold) triggers, and any associated data from DRS and/or GCHS, will be reviewed by the lead failure adjudication committee to determine the cause of the RV LIA alert or impedance nominal threshold crossing.
Study Population Description This is a retrospective analysis of existing data from CareLink. Among the large number of patients and clinics that use CareLink to manage their devices, there are some that have already been implanted with a combination of an RV LIA enabled device and an RV defibrillation lead not manufactured by Medtronic. There are three Medtronic sources of information that will be used to support this analysis:

¿X Data Warehousing and Analytics Services (DWAS)

¿X Device Registration System (DRS)

¿X Global Complaint Handling System (GCHS)



The DWAS, DRS and GCHS databases will be queried as follows to obtain all necessary data. All Medtronic devices that were connected to non-Medtronic RV defibrillation leads and had the RV LIA algorithm active prior to the data cutoff will be queried. The cutoff date will be set to a date on or after October 4, 2013.

Sample Size As there are no hypotheses being tested for this analysis, there are no powered sample size estimates. However, two requirements were identified to determine the sample size and timing of the analysis. First was to ensure the amount of lead follow-up is at least the size of the PMA analysis (11,052 RV LIA years of follow up across both St. Jude and Boston Scientific leads) and secondly the analysis will occur after PMA approval. Current estimates are that the RV LIA years of follow-up since the PMA cut off of October 4, 2011 has already been exceeded with approximately 14,500 years of RV LIA enabled follow-up. Therefore, assuming event rates remain the same as in the PMA cohort, it is expected at 77 additional lead events will be included in this study which is 28% more than the 60 true lead events observed across both manufacturers in the PMA analysis. The data cut off for analysis will be the first day after PMA approval in which the RV LIA enabled years of follow-up is greater than 11,050 years of follow-up.
Data Collection There are three Medtronic sources of information that will be used to support this analysis:

? Data Warehousing and Analytics Services (DWAS)

? Device Registration System (DRS)

? Global Complaint Handling System (GCHS)



The DWAS, DRS and GCHS databases will be queried as follows to obtain all necessary data. All Medtronic devices that were connected to non-Medtronic RV defibrillation leads and had the RV LIA algorithm active prior to the data cutoff will be queried. The cutoff date will be set to a date on or after October 4, 2013.



Primary Objective:

To summarize the number of lead failure events associated with RV LIA triggers and impedance nominal threshold crossings. This objective will be evaluated separately for each lead manufacturer (i.e. St. Jude Medical Riata/Durata leads and Boston Scientific Endotak leads).



Secondary Objective:

To summarize the number of other detected events associated with RV LIA triggers and impedance nominal threshold crossings. This objective will be evaluated separately for each lead manufacturer (i.e. St. Jude Medical Riata/Durata leads and Boston Scientific Endotak leads).

Follow-up Visits and Length of Follow-up No follow-up visits and length of follow-up
Final Study Results
Number of Patients 5753 devices
Number of Sites N/A
Follow-up Rate N/A
Safety Findings N/A
Effect Findings The incidence of right ventricular (RV) Lead Integrity Alert (LIA) trigger or impedance nominal threshold during the post-approval period was low in St. Jude Medical (STJ) Riata/Durata leads and Boston Scientific (BSX) Endotak leads (0.725% per device year in STJ leads and 1.23% per device year in BSX leads). The majority of identified triggers classified as lead failure events (LFEs) or other detected events (ODE) were detected by only the RVLIA criterion in both STJ and BSX leads. These findings were consistent with events identified during the original analysis supporting the PMA labeling language for RV LIA use with Non- Medtronic leads.
Strengths & Weaknesses Strength: Large sample size;

Weakness: Retrospective data analysis. Lack of data presented to support advance warning of RV LIA

relative to lead failure events. No data available on the positive predictive value or negative predictive value.

Label Changes No


LIA in Non-MDT Leads Surveillance Update Analysis Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report-FINAL 03/26/2014 03/05/2014 On Time


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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