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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Elana Surgical KitHUD

General
Study Status	Other
Application Number / Requirement Number	H080005 / PAS001
Date Original Protocol Accepted	03/10/2011
Date Current Protocol Accepted	01/03/2012
Study Name	Elana Surgical KitHUD
Device Name	ELANA ARTERIOTOMY SYSTEM
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 Objectives	Post Approval Registry
Study Population	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.
Key Study Endpoints	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.

Elana Surgical KitHUD Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	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

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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