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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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COROX LEAD (COSMO)


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General
Application Number P050023 / PAS001
Current Plan Approved 08/10/2006
Study Name COROX LEAD (COSMO)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description In this study patients are enrolled 1-30 days after successful implantation of the Corox OTW Steroid LV lead connected to a BIOTRONIK CRT-D device. Successful implantation is defined as when the pacing threshold of the Corox OTW Steroid LV lead is less than one-half of the maximum programmed output of the BIOTRONIK CRT-D at 0.5 ms without phrenic nerve stimulation.
Study Population Description Study Population: Patients implanted with the Corox OTW Steriod LV lead.
Sample Size 250 subjects, at up to 100 sites
Data Collection The evaluation of safety is based on the analysis of Corox over-the-wire Steroid lead related adverse events that are classified into two types: observations and complications. Additionally, left ventricular lead pacing parameters (acute and chronic pacing thresholds and impedance values) will be evaluated. The study data will also be used to determine the ability of the Corox over-the-wire steroid lead to deliver chronic cardiac resynchronization pacing.
Follow-up Visits and Length of Follow-up The patients will be followed for a period of three years. The specific visits that are part of this registry are at enrollment, 3-months, 6-months, 1-year, and routine follow-ups (every subsequent 6 months). It is required that patients are seen at 3, 6, 12, 18, 24, 30, and 36 months post enrollment within ± 1-month at the first (3month) follow-up and at ± 45 days for all subsequent routine follow-ups thereafter.
Final Study Results
Interim Safety Information As of July 17, 2009, 885 total subject visits had been reported in 221 subjects. There were 22 subjects (10.0%) with a reported threshold higher than 3.7 V at any follow up. Of these 22 subjects, only 2 subjects (0.9% of total) were not able to be reprogrammed to continue biventricular pacing with capture, by increasing the pacing voltage or by increasing the pacing pulse width. Most of these subjects experienced an LV pacing threshold above 3.7 V at only one of their follow-ups. Also of these 22 subjects, there were 3 (1.4% of total) with a reported complication due to a LV lead revision. The proportion of resultant complications resulting from operation outside of the specified parameters is low. Less than half (n=112) of the required participants (n=250) have been followed out to three years. At this time, the current KM estimates of the cumulative event-free survival probabilities do not warrant concern, as they are in keeping with other comparable devices.
Number of Patients 221
Number of Sites 34
Follow-up Rate 59% through three years
Safety Findings Observations. A total of 23 (10.4%) of the enrolled patients have reported a Corox OTW Steroid Unipolar lead related observation. The rate of Corox OTW Steroid Unipolar lead related observations per patient-year is 0.056. Ten observations were due to high LV lead threshold, 14 were from phrenic nerve stimulation, and one was from intermittent loss of capture.



Complications. A total of 9 (4.1%) of the enrolled patients experienced a Corox OTW Steroid Unipolar lead related complication. The rate of Corox OTW Steroid Unipolar lead related complications per patient-year is 0.019. The eight complications were: LV lead dislodgement (3), phrenic nerve stimulation (1), infection (2), high LV lead threshold (2), and lead integrity compromise (1).



Effect Findings

At all scheduled follow-up intervals and interim visits, the CRT system provided appropriate biventricular pacing with capture in 91.9% to 97.8% of subjects. The average overall LV lead impedance was 709 ± 176 ohms. When measured at 0.5 ms pulse width, the average LV lead threshold was 1.3 ± 0.9 ms at enrollment and for all follow-ups was 1.3 ± 1.1 V. In total 1200 subject visits had been reported in 221 subjects.

Strengths & Weaknesses

The study results they provide little long term follow-up of the lead. Overall the lead appears to cause few complications although the data collection is weak and adverse events might have occurred but not been reported.

Label Changes Updated to include the long-term post-approval study data and findings.



COROX LEAD (COSMO) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report COROX/TUPOS LV 08/10/2007 08/08/2007 On Time
2 year report COROX 08/08/2008 08/08/2008 On Time
3 year report COROX 08/10/2009 08/05/2009 On Time
4 year report COROX 08/10/2010 08/10/2010 On Time
5 year report 08/10/2011 08/10/2011 On Time
Final Report 03/06/2012 03/06/2012 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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