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.
Transit. Adolescent B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
This is an open-label prospective observational study of patients treated with the RNS System. Patients
are from both continued follow-up of premarket cohorts and new enrollment.
Study Population Description
All patients implanted with the RNS Neurostimulator and/or Lead(s), including patients in the LTT study
and the RNS System PAS2 study, as well as non-study patients whose product data are monitoring systems that consent and have surgical procedures for explant/removal, reimplantation, or revision of the Neurostimulator and Lead(s).
A minimum of 20 procedures to remove a Lead must be collected.
The incidence and number of adverse events related to surgical
procedures associated with implant, explant/removal, reimplantation,
and revision of the Neurostimulator and Lead(s)
Two groups of adverse events will be presented: (1) adverse events that lead to a surgical procedure, and (2) adverse events that occur as a consequence of a surgical procedure (i.e. complication). Within each of the 2 adverse event groups, the incidence and number of events will be presented for 3 categories: