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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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OSB Lead-Chronic Extraction

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Application Number P060039 / PAS001
Current Plan Approved 09/12/2014
Study Name OSB Lead-Chronic Extraction
General Study Protocol Parameters
Study Design Case Control Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The purpose of this study is to characterize the removability of the Attain StarFixModel 4195 Left Ventricular Lead (StarFix). This study will evaluate the lead removal success in patients that are indicated for left ventricular lead removal.
Study Population Description The Attain StarFix Model 4195 steroid eluting, transvenous lead with deployable lobe fixation is intended for chronic pacing and sensing of the left ventricle via the cardiac vein, when used in conjunction with a compatible implantable pulse generator or implantable cardiac defibrillator. The study population consists of subjects of either genders that are indicated for a Model 4195 or a non-Model 4195 Medtronic lead extraction who meet all inclusion criteria are eligible for this study. The baseline date (from Baseline CRF) is designated as the date on which the inclusion criteria are verified and must be within 30 calendar days prior to left ventricular lead extraction attempt. The extraction procedure must occur at least 181 days after implant for subjects included in the primary objective.
Sample Size 120 study subjects (Model 4195 and non-Model 4195 implanted subjects) will be enrolled in the study for the primary objective. A separate cohort of up to an additional 20 subjects with Model 4195 implanted from 90 to 180 days leads will be enrolled, 25 sites
Data Collection The primary objective of the study is to compare the removal success of the Model 4195 lead to other Medtronic left ventricular lead models and to test the null hypothesis that the probability of removal of the Model 4195 left ventricular lead is less than other Medtronic left ventricular leads by 20%. The primary end point (extraction success rate) will be first evaluated at the end of three years or when 40 subjects are enrolled in the Model 4195 lead group, whichever comes first.
Follow-up Visits and Length of Follow-up Subjects will be followed at one month after extraction attempt. The one month follow-up can be completed via in person visit, telephone or data collection from primary care center. Subjects will be exited from the study upon completion of the one month follow-up or after all Adverse Events have been resolved, whichever is later.
Final Study Results
Interim Safety Information As of the time of this report there had been a total of five (5) AEs have been reported, one (1) AE had been adjudicated by the EAC. The adjudicated event was post procedural swelling. At the time of this report seven (7) leads had been returned to Medtronic for returned product analysis. Analysis has been completed on three (3) of the seven leads. No anomalies were found on any of the analyzed leads. One of the returned leads was a 4195 model.
Number of Patients 227 subjects
Number of Sites 24 centers
Follow-up Rate 89.77%
Safety Findings Extraction success is either: 1) removal of all targeted leads and all lead material from the vascular space, with the absence of any permanently disabling complication or procedure related death; or 2) removal of all targeted leads except for the retention of a small portion of the lead that does not negatively impact the outcome goals of the procedure. This may be the tip of the lead or a small part of the lead (conductor coil, insulation, or the latter two combined) when the residual part does not increase the risk of perforation, embolic events, perpetuation of infection or cause any undesired outcome

The observed extraction success rate for model 4195 LV leads implanted greater than 181 days was

92.5% (37/40) compared to a success rate of 98.8% (163/165) for Non Model 4195 Leads.

Effect Findings NA
Strengths & Weaknesses Strength: The high follow-up rate: 89.77%

Weaknesses: Limited number of leads studied: 40 Model 4195 leads

Label Changes Yes (Labeling updates has been approved in P060039/S056)

OSB Lead-Chronic Extraction Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 07/28/2009 07/28/2009 On Time
1 year report 02/02/2010 02/02/2010 On Time
18 month report 07/28/2010 07/28/2010 On Time
24 month report 01/28/2011 01/27/2011 On Time
3 year report 08/13/2011 07/28/2011 On Time
42 month report 02/12/2012 02/02/2012 On Time
4 year report 08/12/2012 08/10/2012 On Time
54 month report 02/11/2013 02/11/2013 On Time
5 year report 08/12/2013 08/12/2013 On Time
66 month report 02/11/2014 02/14/2014 Overdue/Received
72 month report 08/13/2014 08/13/2014 On Time
Final Report 12/12/2014 12/11/2014 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

Phone: (301) 796-6134
Fax: (301) 847-8140

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