DuraSeal Dural Sealant has been approved as a dural sealant by the FDA for use in cranial and
spinal procedures. This study was completed to further evaluate the safety of the DuraSeal
Sealant in a post-approval setting as compared to control (defined as methods typically
employed by surgeons to seal the dura).
- Patient is between 18 and 75 years of age
- Patient is scheduled for an elective cranial procedure that entails a dural incision
- Evidence of intraoperative non-watertight closure