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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-Post Approval Study


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General
Application Number P040040 / PAS002
Current Plan Approved 03/18/2016
Study Name OSB Lead-Post Approval Study
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21, All Pediatric Patients: 0-21 yrs
Detailed Study Protocol Parameters
Study Design Description This study is a prospective, non-randomized, multi-site clinical study.



The primary safety objective is to evaluate the proportion of subjects experiencing a major (serious) adverse event within 12 months of the procedure.



The effectiveness objective is to evaluate the proportion of subjects whom experience technical success, closure success, and acute procedure success.



Study Population Description This device is indicated for use in patients with a complex VSD of significant size to warrant closure (large volume left to right shunt, pulmonary hypertension and or clinical symptoms of congestive heart failure) who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and or based on overall medical condition. Eligible patients can be enrolled retrospectively.



The comparison group is the Historical Control.

Sample Size One hundred (100) subjects will be enrolled at up to 50 U.S. sites and additional sites in Europe and Canada.



If subject follow-up drops below 80%, additional subjects will be enrolled to ensure a final population of 80 subjects either meet a defined endpoint or are followed for five years.

Data Collection Primary safety endpoint:

Any major (serious) adverse event within 12 months of the procedure. A serious adverse event is defined as any untoward medical occurrence that:

results in death;

is a life-threatening adverse event;

requires inpatient hospitalization or prolongation of existing hospitalization;

results in persistent or significant disability/incapacity; or

is a medically significant event.



Primary effectiveness endpoints:

Technical Success

Acute Procedure Success

Shunt Closure Success at 12 months

Follow-up Visits and Length of Follow-up Each study subject receiving a device will be followed for 60 months post-procedure, unless the device is explanted.

Follow-up assessments will be conducted at 30 days, 6 months , one year, and annually until the five-year visit is complete.



If the delivery system enters the subject’s body in an attempt to place a device but no device is implanted during the initial procedure, the subject will be discontinued from the study after a 30-day adverse event collection period.



If the device explant occurs before the 12-month visit and a SAE is associated with the device explant, the subject will be discontinued on the date the device is explanted. (In this case, the subject is considered a failure for all endpoints except Technical Success.)



If a device explant is not associated with a SAE, the subject will continue to be followed through the 12-month visit. The subject will then be discontinued at the 12-month visit. If a subject has a device explanted after the 12-month visit, the subject will be discontinued on the date of the explant procedure.



Final Study Results
Interim Safety Information Six adverse events have occurred in 8 subjects. The adverse events do not raise any concerns at this time.


OSB Lead-Post Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 10/01/2008 09/08/2008 On Time
2 year report 09/06/2009 09/03/2009 Overdue
3 year report 09/06/2010 09/07/2010 Overdue/Received
4 year report 09/06/2011 09/06/2011 On Time
5 year report 09/05/2012 09/05/2012 On Time
6 year report 09/05/2013 08/30/2013 On Time
7 year report 09/05/2014 09/05/2014 On Time
8 year report 09/05/2015 09/08/2015 Overdue/Received
9 year report 09/04/2016 09/02/2016 On Time
10 year report 09/04/2017    


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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