In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
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
Followup Visits and Length of Followup
Post-operative
Information will be collected pre-operatively, during the operation and one post operative follow up (>25
