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 is a prospective cohort study that involves continued follow-up of the premarket cohort. The
goal of this post-approval study is to assess longer-term performance of the BRYAN Cervical Disc in the treatment of patients with cervical degenerative disc disease. The primary consideration of longer-term performance will be overall success, a composite variable comprised of key safety and effectiveness parameters. The overall success rate for the BRYAN disc treatment will be compared to that of a concurrent fusion control group. Study success will be based on showing non-inferiority for the BRYAN device group overall success rate at ten years following surgery. The secondary objective of the study is to assess superiority, if non-inferiority can be established.
Study Population Description
Study population is as per device indication. This device is indicated in skeletally mature patients
for reconstruction of the disc from C3-C7 following single-level discectomy for intractable radiculopathy and/or myelopathy. The BRYAN device is implanted via an open anterior approach.
Sample Size
Postoperative data will be collected at 5, 7, and 10 years on a minimum of
200 eligible patients (minimum of 100 patients each from control and BRYAN groups)
Data Collection
The primary outcome variable, overall success, is defined below. A patient will be considered an
overall success if all of the following conditions are met:
Followup Visits and Length of Followup
Data will be collected at 60 months (5 years), 84 months (7 years), and 120
months (10 years) postoperative to determine the long-term safety and effectiveness of the device.
