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

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OSB Lead-Elana Surgical KitHUD

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Study Status Other
Application Number H080005 / PAS001
Date Current Protocol Accepted 01/03/2012
Study Name OSB Lead-Elana Surgical KitHUD
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 A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Post Approval Registry
Study Population Description All patients selected for a procedure with the Elana Surgical Kit will be part of the registry study. This will be an 'all comers' registry with no inclusion or exclusion criteria. The registry will collect data of all device uses.
Sample Size It is expected that a site can select between 3-5 patients on an

annual basis. The total expected number of sites in the USA is around 10-15. The total sample size for this registry is set at 80 device uses.

The sample size for this study was selected based on the primary endpoint. The total of 80 device uses will provide 80% power for showing the flap retention rate does not exceed 38% under the assumption that the true rate is 22%. The true flap retention rate of 22% is based on the results of an IDE study on 37 device uses.
Data Collection Primary endpoint

The ability of the Elana Surgical Kit to retrieve a flap (circular disk of tissue) on the tip of the Elana Catheter while creating an arteriotomy. The flap retrieval will be judged successful, if the flap is retrieved on the tip of the Elana Catheter. The flap retrieval will be judged unsuccessful if the flap was either manually retrieved or not retrieved (= flap retention).

Secondary measures

Mortality and non fatal strokes will be recorded and described
Follow-up Visits and Length of Follow-up Post-operative

Information will be collected pre-operatively, during the operation and one post operative follow up (>25 days) will be done.

OSB Lead-Elana Surgical KitHUD Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 09/08/2011 11/22/2011 Overdue/Received
one year report 03/09/2012 03/07/2012 On Time
18 month report 09/07/2012 09/05/2012 On Time
two year report 03/09/2013 03/07/2013 On Time
three year report 03/09/2014 03/18/2014 Overdue/Received
four year report 03/09/2015 03/09/2015 On Time
five year report 03/09/2016 03/08/2016 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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