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.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
This study is a 5-year, prospective, non-randomized, multi-center parallel study of implanted nEw3 (Adapta /Sensia/Versa)
devices using a historical comparison group. Subjects will be compared against the U.S. market released Adapta /Sensia/Versa IPGs historical control group consisting of Medtronic registered devices as reported in the Medtronic Cardiac Rhythm Disease Management Product Performance Report
Study Population Description
Study Population: All enrolled subjects have been implanted with a nEw3 device. Indication: The indications
include: 1) rate adaptive pacing in patients who may benefit from increased pacing rates
concurrent with increases in activity, 2) accepted patient conditions warranting chronic cardiac pacing, 3) symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders, 4) the Medtronic AT500 system is also indicated for dual chamber and atrial tracking
modes in patients who may benefit from maintenance of AV synchrony.
Sample Size
At least 222 patients to ensure that at least 200 subjects are followed for 5
years, it is estimated that approximately 336 subjects will need to be enrolled, 72 sites
Data Collection
Medtronic CRDM considers a device as having malfunctioned whenever the analysis shows that any parameter
was outside the performance limits established by Medtronic while implanted and in service. To be considered a malfunction, the device must have been returned to Medtronic and analyzed as a confirmed device malfunction. All subjects in the SLS study with a nEw3 device will be included until the cohort for analysis is met. Any nEw3 devices returned to Medtronic through returned product and found to have malfunctioned within 6 months after implant will also be included in the analysis. Devices damaged after explant, damaged due to failure to heed warnings or contraindications in the labeling, or damaged due to interaction with other implanted devices (including leads) are not considered device malfunctions.
Followup Visits and Length of Followup
All subjects who are included in the analysis of the primary objective will continue to
be followed for a total of 5 years post-implant. The follow-up schedule for this study is based on utilizing routine, scheduled office/clinic visits and unscheduled office/clinic visits prompted by symptoms or complaints. Follow-up office/clinic visits post-implant are suggested to be at least annually for subjects with an IPG, and a minimum of one follow-up visit every 24 months.
