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.
No significant safety problems were reported at 36 months. A clinically significant decrease in systolic
blood pressure was sustained for 36 months.
Final Effectiveness Findings
The rate of the primary endpoint was 91.7% and the lower limit of the 95%
two-sided confidence interval was 84.2%. The primary premarket hypothesis tested was the 9-month primary patency rate that resulted greater than 60% (p < 0.001). Therefore, the rate was higher than the performance goal. Technical Success was 97.4% (112/115) on a per lesion basis.
Study Strengths and Weaknesses
Results provide further evidence of the clinical utility and safety of this device.
Recommendations for Labeling Changes
Post-approval study findings should be part of the device labeling, including the following key safety
findings: the 9-month primary patency rate (table 3.10-1), Major Adverse Events (table 3.11.1-1), technical success, acute procedural success (tables 3.11.2-1 and3.11.3-1), blood pressure results (table220.127.116.11-1) cured and improved hypertension at 36 months (table 18.104.22.168-
1) and renal function results (tables 3.11.7-1 and 3.11.7-2).