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 to continue follow-up of the subjects who participated in (1)
the IDE premarket study and (2) the continued access arm and metal ion study.
Study Population Description
Study population is as per device indication. The study include IDE, CAS and metal ion
study subjects. 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. Intractable radiculopathy and/or myelopathy should present with at least one of the following items producing symptomatic nerve root and/or spinal cord compression which is documented by patient history (e.g., pain [neck and/or arm pain], functional deficit, and/or neurological deficit), and radiographic studies (e.g., CT, MRI, x-rays, etc.): 1) herniated disc, and/or 2) osteophyte formation. The PRESTIGE 9 device is implanted via an open anterior approach.
Sample Size
A minimum of 200 patients (minimum of 100 patients each from control and PRESTIGE groups)
at 7-year follow-up
Data Collection
A patient will be considered an overall success if all of the following conditions are
met:
1. Postoperative Neck Disability Index score improvement of at least a 15-point increase from preoperative;
2. Maintenance or improvement in neurological status from preoperative;
3. Functional spinal unit height success;
4. No serious adverse event classified as implant associated or implant/surgical procedure associated; and
5. No additional surgical procedure classified as a "failure".
Followup Visits and Length of Followup
Postoperative data will be collected at 3, 5, and 7 years
