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.
Total number of device- or procedure-related adverse reported = 62
Most common organ class was general
disorders and administration site conditions- 46 events
Proportion of subjects with device- or procedure-related adverse events, overall - 50.7% (36/71)
Total number of device- or procedure-related serious adverse events reported = 40
Most common organ class was general disorders and administration site conditions- 31 events
Proportion of subjects with device- or procedure-related serious adverse events, overall – 35.2% (25/71)
Final Effectiveness Findings
The primary patency rate at 36 months by Kaplan Meier (KM) estimate was 40.6%
Secondary Endpoints (by Kaplan Meier Analysis)
Primary Assisted Patency rate at 24 and 36 months was 65.3% and 53.0% respectively
Secondary patency rate at 24 and 36 months was 96.9% at each timepoint
Freedom from target lesion revascularizations at 24 and 36 months was 65.1% and 55.5% respectively
Freedom from the composite of death, target vessel revascularization and amputation at 24 and 36 months was 56.5% and 44.5% respectively
The clinical Success rate at 24 and 36 months was 76.7% and 58.5% respectively. There were no reports of device fracture on X-ray
Study Strengths and Weaknesses
The study achieved an adequate follow-up rate of 90.2% at 3 years.
This was a single
arm study without a comparator. Thus, the study result was not evaluated by a formal statistical test.
Recommendations for Labeling Changes
Labeling change is recommended to reflect the long term data from the post-approval study. The
labeling change should include a new section on the label showing a summary of the post-approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoints, follow –up visits etc.), final results and study strengths and limitations of the PAS.