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
This is an observational, multi-site, one armed prospective cohort study of patients with aneurysms treated
with the TAG device.
Study Population Description
The study will enroll subjects diagnosed with aneurysm of the DTA who meet all inclusion/exclusion
criteria. Patients previously treated with the commercially approved TAG device by a physician who has completed the GORE TAG Physician Training program may be retrospectively screened for enrollment into this study.
Sample Size
150 patients from 25 sites
Data Collection
The incidence of major adverse events at 30 days post-implant. Major Adverse Event are defined
as those requiring therapy and short hospitalization (24-48 hours), major therapy, unplanned increase in level of care, prolonged hospitalization, permanent adverse sequelae, or death.
Followup Visits and Length of Followup
Patients are evaluated at 30 days post-implant.
Final Study Results
Actual Number of Patients Enrolled
150 patients
Actual Number of Sites Enrolled
25 sites
Patient Followup Rate
100%
Final Safety Findings
All success criteria were met
Study Strengths and Weaknesses
Strength: Very good patient follow-up; Data collection was complete
