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.
This is a prospective, non-randomized, open-label, multicenter study, which will include subjects from the premarket
study cohorts and new enrollment of subjects receiving the device in the postmarket.
Study Population Description
Group A: Active prospective study subjects. Group B: Subjects previously enrolled in the premarket trials PUMP
I or PUMP II will be offered voluntary participation in the post-approval study. Subjects in Group B will be followed for a total of five years, which includes all time enrolled in the previous PUMP study.
Primary endpoint is to assess long-term occurrence and safety as a result of granuloma formation. Secondary
endpoints are to assess the long-term device performance including: -Pump failure, including time to occurrence, type, and number of occurrences -Pump battery life The additional endpoint will include: -Device-related adverse events -Device-related serious adverse events -The effect of race and ethnicity on granuloma formation -The effect of alternative drugs on granuloma formation
Followup Visits and Length of Followup
5 years Subjects shall be seen at least once every 90 days (± 30 days) from
the date of implantation (Group A) or enrollment (Group B) throughout the study
OSB Lead-Prometra Programmable Pump system