Post-Approval Studies (PAS) Database

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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Bipolar Model 4968

General
Study Status	Completed
Application Number / Requirement Number	P950024 S002/ PAS001
Date Original Protocol Accepted	09/16/1999
Date Current Protocol Accepted
Study Name	Bipolar Model 4968
Device Name	MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695
General Study Protocol Parameters
Study Design	Prospective & Retrospective Study
Data Source	Sponsor Registry
Comparison Group	Objective Performance Criterion
Analysis Type	Descriptive
Study Population	Child: 2 yrs < 12 yrs, Adolescent: 13-18 yrs, Transit.Adolescent B(as adults): 18 yrs < 22 yrs, Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives	The post-approval study is a 5-year, multi-center, single arm, prospective and retrospective cohort study. All subjects in the study receive the device.
Study Population	Study Population: Patients implanted with the device. Indication: The Medtronic Model 4968 CapSure Epi Steroid-Eluting Bipolar Epicardial Pacing Lead is an epicardial lead designed for pacing and sensing of either the atrium or ventricle.
Sample Size	100 subjects at multiple sites.
Key Study Endpoints	Endpoints include freedom from lead-related complications and post-market performance of the lead.
Follow-up Visits and Length of Follow-up	There is no specified timeframe for follow-up visits; they occur according to the routine care plan set by each site for all cardiac surgical subjects.
Interim or Final Data Summary
Interim Results	There have been 36 deaths in 370 subjects; 32 lead-related complications and 70 lead-related observations reported.
Actual Number of Patients Enrolled	370
Actual Number of Sites Enrolled	85
Patient Follow-up Rate	69.7%
Final Safety Findings	n/a
Final Effect Findings	The performance for the overall 5-year survival probability of the Model 4968 lead was 92.3%. The 5- year survival probability was 89.3% for patients 12 years old or younger, 93.9% for patients 13 ¿ 19 years of age and 98.9% for patients 20 years of age or older.
Study Strengths & Weaknesses	Strength: prospective, multi-center, long-term follow-up period (5 years). Weakness: Small sample size (101 subjects in 5-year follow up), slow enrollment, extended duration of study, retrospective enrollment, high participation at 2 centers, high complications at 1 center, deviations, missing data, and use of a non-pediatric patient population.
Recommendations for Labeling Changes	Yes

Bipolar Model 4968 Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
interim report	10/25/2009	10/26/2009	Overdue/Received
Final Report	04/20/2010	04/14/2010	On Time
Resp to A3 NORE - revised PAS report	01/31/2011	02/09/2011	Overdue/Received
resp to R23 A6 RDEF - final report	12/07/2011	12/02/2011	On Time

Contact Us

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Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background