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.
The rate of cardiac death and MI through 5 years was 29.2% (21/72) [19.0%, 41.1%].
Study Strengths and Weaknesses
This study provides longer term (5 years) safety and effectiveness results of Presillion CoCr Coronary
Stent RX System. The study had a low rate of attrition, thus minimizing selection bias. This study follows up the premarket cohort to provide earlier, descriptive information on long-term performance, as such the study had a small sample size and its results are descriptive. The generalizability of the results from this outside the United States population is limited to Israeli patients. This limitation is being addressed through the conduct of the second condition of approval study, ¿Enrollment of New US Cohort¿. The combined data will provide early information on long-term device performance and generalizable, statistically powered findings.
Recommendations for Labeling Changes
A labeling change is recommended to add a summary of the post-approval study results including
study strengths and limitations. The updated label will reflect the long-term (5-years) postmarket performance of the device.
OSB Lead-Continued f/u of BLAST Placebo Cohort