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
Sponsor collects the information for any adverse events and complaints, including those which are not
associated with any adverse clinical effect, received by the company for the BRYAN device following PMA approval.
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 primary outcome variable, overall success, is defined below. A patient will be considered an
overall success if all of the following conditions are met:
- Postoperative Neck Disability Index score improvement of at least 15-points from preoperative (score decrease signifies improvement);
- Maintenance or improvement in neurological status from preoperative;
- No serious adverse event classified as implant associated or implant/surgical procedure associated; and
- No additional surgical procedure classified as a "failure". Second surgery "failures" are additional surgeries that occur after the treatment surgery that affect the original device configuration.
Followup Visits and Length of Followup
This reporting occurs at six-month intervals for the first two years of approval and then
continues on an annual basis until five years after PMA approval.
Final Study Results
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled
N/A - enhanced surveillance study
Patient Followup Rate
Not applicable enhanced surveillance study
The study duration was 5 years.
Final Safety Findings
A cumulative total of 1950* implants have been sold in the U.S. since the PMA
approval date of May 12,
2009 to March 11, 2014. A cumulative total of twenty five MDRs have been reported for implants sold in the U.S. since the approval date to March 11, 2014. A cumulative total of twenty MDRs have been reported for instruments sold in the U.S. since the approval date. A cumulative total of 7769 implants have been sold outside of the U.S. since the PMA approval date of May 12, 2009 to March 11, 2014. A cumulative total of 86 MDRs have been reported for implants sold outside of the U.S. since the approval date to March 11, 2014.
Final Effectiveness Findings
Study Strengths and Weaknesses
The study permitted monitoring of the AEs occurrence in the broader population of the device
Due to the study design it is impossible to meaningfully evaluate the AEs rates. Further, due to study design and lack of clinical information reported to the company it is difficult to find any particular trends in occurrence of heterotopic ossification and osteolysis.
Recommendations for Labeling Changes
Bryan Cervical Disc implantation associated with higher level of surrounding tissue dissection than other artificial
disc systems currently on the market. This in turn leads to higher incidents of HO. The HO incidents were observed in the ESS study.