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
The PAS is a prospective, randomized, single-blinded (patients), multi-center study to further characterize the DuraSeal
Sealant as compared to "standard of care" in patients scheduled for cranial surgery that entails a dural incision.
Study Population Description
This device is indicated for use as an adjunct to sutured dural repair during cranial
surgery to provide watertight closure.The study population includes subjects scheduled for clean, elective cranial surgery that entail dural incisions that are closed primarily with sutures with or without autologous duraplasty. To be eligible for the study, subjects had to be between 18 and 75 years of age, scheduled for an elective cranial procedure entailing a dural incision, and provided informed consent on an IRB approved consent form, and intra-operatively, there must have been evidence of non watertight closure after primary dural closure, either spontaneously or upon Valsalva maneuver, at 20 cm water for 5-10 seconds.
Sample Size
250 patients; approximately 25 centers
Data Collection
The primary outcome is the incidence of neurosurgical complications related to unplanned intervention (i.e., minimally
invasive procedures) or return to the operating room. The secondary outcomes are 1) the incidence of post-operative surgical site infections within 30 days post-operation defined as (a) Superficial Incisional, (b) Deep Incisional, (c) Organ/Space; and 2) the presence or absence of CSF leaks within 30 days post-operation as determined from clinical diagnosis.
Followup Visits and Length of Followup
Patients are followed for 30 days after treatment, and are evaluated clinically at discharge and
at 30 days post-procedure.
Final Study Results
Actual Number of Patients Enrolled
237 patients
Actual Number of Sites Enrolled
17 centers
Patient Followup Rate
98.30%
Final Safety Findings
There were 18 primary endpoint complications in 16 subjects: 9 happened in 8 patients in
the DuraSeal group of which 6 (66.7%) were procedure related, 1 treatment related (11.1%), 1 not related and 1 unable to determine. Nine happened in 8 patients in the standard of care group: 7 (77.7%) were procedure related and 2 were treatment related (22.2%). All reported neurosurgical complications for the DuraSeal Sealant group are anticipated and expected. The incidence and nature of the complications that have been reported are consistent with the type and complexity of the procedures performed.
Study Strengths and Weaknesses
High follow up rate. Randomized design.
Recommendations for Labeling Changes
The sponsor updated the labeling to reflect the post-approval study results prior to FDA completing
review of the final report. The lableing changes were also reviewed by FDA and the labeling does reflect the study results.
